Two-Year Data of Pimicotinib Demonstrated Durable Tumor Control and Sustained Improvement in TGCT Symptoms and Joint Function

DARMSTADT, Germany - Monday, 26. October 2026



    Improvements in symptoms of pain, stiffness, and range of motion were sustained through two years

    Tumor responses remained robust1 and durable2

Not intended for U.K.-, U.S.- or Canada-based media

 

(BUSINESS WIRE) -- Merck, a leading science and technology company, today announced new two-year follow-up results from the Phase 3 MANEUVER study evaluating pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The study showed that among patients initially randomized to pimicotinib, improvements in symptoms and joint function were observed as early as Week 5, sustained through two years, and continued to improve over time. Tumor responses remained robust1 and durable,2 and the safety profile was consistent with previous analyses. The findings are being presented today in the Sarcoma poster session at the European Society for Medical Oncology (ESMO) Congress 2026 (Presentation # 3747P).

"For people living with TGCT, the impact of the disease is often felt through persistent limitations in mobility, physical function and the ability to carry out everyday activities," said Vinod Ravi, MD, MS, MBA, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, an investigator on the MANEUVER trial. "What is encouraging about these two-year findings is the consistency of improvements, not only in the durability of tumor response, but across the symptoms and functional outcomes that matter to patients. Together with the observed safety profile, these results provide important insight into the potential for pimicotinib to deliver meaningful benefit over time."

The new analysis in patients initially randomized to pimicotinib found that at Week 97, mean changes from baseline were 19.6% in range of motion, -3.9 in stiffness (as measured by the Worst Stiffness Numeric Scale Rating), -3.1 in pain (as measured by the Brief Pain Inventory worst pain rating) and +7.4 in physical function (as measured by the patient-reported PROMIS-PF scale).

Tumor responses also remained robust1 and durable2 through two years. Objective Response Rate (ORR) by blinded independent review committee (BICR) per RECIST v1.1 was 76.2% (95% CI: 63.8, 86.0), remaining unchanged from the one-year analysis, while ORR per BIRC based on tumor volume score (TVS) increased from 74.6% at one year to 77.8% (95% CI: 65.5, 87.3) at two years. Median duration of response was not reached at the time of analysis, and median treatment duration was 22.6 months (range: 1.8-33.6 months) at the March 1, 2026 data cutoff. Fifty-four percent of patients initially randomized to pimicotinib remained on treatment at two years.

In MANEUVER, pimicotinib was well-tolerated, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. During the randomized, double-blind treatment phase of the trial, treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients.

"These two-year findings add to the growing body of evidence from the MANEUVER study demonstrating the potential for pimicotinib to meaningfully address some of the burden of TGCT," said David Weinreich, MD, MBA, Global Head of R&D and Chief Medical Officer for the Healthcare business of Merck. “The sustained improvements observed across symptoms, physical function and tumor control reinforce the potential of pimicotinib to address aspects of TGCT that can affect patients every day. These results add to our evolving understanding of the long-term benefit that pimicotinib may provide for people living with this debilitating rare tumor."

TGCT is a rare, locally aggressive tumor occurring in or around the joints leading to progressive worsening of symptoms including pain and reduced mobility of the affected joint, significantly impacting physical function in what is typically an otherwise healthy and young adult population. Patient-reported experiences indicate that up to half of people with TGCT may initially receive an incorrect diagnosis, which can delay appropriate disease management.3 If left untreated or in recurrent cases, TGCT may result in cumulative morbidity and irreversible damage to the bone, joint and surrounding tissues.

Pimicotinib was approved in China by the China National Medical Products Administration (NMPA) in December 2025 and in Canada by Health Canada in June 2026 for the treatment of adult patients with symptomatic TGCT. A regulatory application is currently under review by the U.S. Food and Drug Administration (FDA) and other regulatory agencies.

1 54% ORR as assessed by BIRC based on RECIST v1.1 at week 25 vs. 3% with placebo; p<0.0001.

2 The majority (77%) of patients with response at 25 weeks maintained this clinical benefit after an additional 12 months of treatment.

3 Stern S, et al. Localized and diffuse tenosynovial giant cell tumor: real-world results from a patient observational registry. Future Oncol. 2025;21(12):1501-1510.

About MANEUVER

The pivotal, global Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pimicotinib in patients with TGCT who were eligible for systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy.

The ongoing study is being conducted by Abbisko Therapeutics and enrolled patients globally in U.S., Canada and Europe (n=49) and China (n=45).

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of pimicotinib (n=63) or placebo (n=31) for 24 weeks. In addition to the primary endpoint of ORR at week 25, as measured by RECIST v1.1 by BICR, secondary endpoints include tumor volume score (TVS), relative range of motion, stiffness by Numeric Rating Scale (NRS), pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS-PF).

After the double-blind Part 1, all eligible patients from either arm could continue to the open-label Part 2 and receive up to 24 weeks of pimicotinib treatment. Patients who completed Part 2 could then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About Pimicotinib (ABSK021)

Pimicotinib, developed by Abbisko Therapeutics, is a novel, orally administered, selective and potent small-molecule inhibitor of CSF-1R. Pimicotinib has been approved for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity by China National Medical Products Administration (NMPA) and Health Canada. It has been granted breakthrough therapy designation (BTD) for the treatment of inoperable TGCT by the U.S. Food and Drug Administration (FDA), and priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for pimicotinib.

About Merck

Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2025, Merck generated sales of € 21.1 billion in 65 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics.

All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

 

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Dubai Culture Opens Registration for ISEA2026 Dubai

 Dubai Culture and Arts Authority (Dubai Culture) has opened registration for the 31st International Symposium on Electronic/Emerging Art (ISEA2026 Dubai), taking place from 6 to 15 November 2026 under the theme ‘ELYAH: Constellating Place, Data and Identity’. The symposium will be the largest edition to date, bringing together artists, researchers, and innovators from around the world to explore the intersection of art, science, and technology and exchange perspectives on the future of contemporary creative practice.

The event supports Dubai Culture’s efforts to advance the digital arts ecosystem, deliver on its Digital Arts Roadmap objectives, and empower local talent. It also reinforces Dubai’s position as a global cultural reference, a leader in innovation, a driver of the creative economy, and rooted in Emirati heritage.

The symposium combines an in-person Artistic Programme across Dubai with an Online Academic Programme accessible from anywhere in the world. The Online Academic Programme will feature Special Track panels and workshops from 6–9 November, followed by the main academic conference sessions from 10–14 November 2026.

Registration for the artistic programme across Dubai is free, while access to the online academic programme requires a paid ticket. All participants must register and will receive a personal QR code for their exclusive use at artistic programme venues. Access details for the Online Academic Programme will be sent to the email address used to book. Students receive a 50% discount when booking with a valid university email address. To register, visit isea2026.eventshub.ai.

The programme will feature over 100 artworks and 145 academic papers, more than 50 artist talks and panel discussions, and over 10 workshops, 45+ Special Track workshops, panels and presentations, seven Eco Lab workshops and more than 20 institutional presentations within the Online Academic Programme. Exhibitions, live and audio-visual performances, installations, interactive and immersive experiences, and open sessions will take place across Dubai, inviting audiences to engage with works that explore the relationship between people, place and technology.

ISEA is one of the world’s leading platforms exploring the relationship between art, science and technology. Its 31st edition will examine four core themes: Charting Constellations, Celestial Dialogues, Eco-Tech Futures and Starlinked Worlds.

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Dubai Chambers launches world's first Agentic AI marketplace by a chamber of commerce

 Dubai, United Arab Emirates - 

Dubai Chambers has launched Chamber AI Hub, the world's first Agentic AI marketplace developed by a chamber of commerce, enabling businesses in Dubai to access ready-to-use AI agents that independently perform a range of administrative and operational tasks.

The marketplace currently offers 22 specialised AI agents across seven business functions including Compliance, Procurement, Operations, Finance, Sales, Human Resources, and Logistics. The offering is set to expand to 100 agents.

The initiative supports Dubai's efforts to accelerate the adoption of Agentic AI across the private sector, helping businesses enhance efficiency, strengthen competitiveness, and transform their operating models.

H.E. Eng. Sultan bin Saeed Al Mansoori, Chairman of Dubai Chambers, commented: “Success in the transition to Agentic AI is measured not by technology adoption alone, but by how effectively companies use these tools to address business challenges and deliver tangible results. This is why we are connecting knowledge with practical application, building capabilities, and expanding access to specialised solutions and high-quality tools that help companies adapt to change and evolve the way they work.”

The marketplace offers practical solutions for tasks including supplier evaluation, contract reviews, invoice matching, business proposal generation, recruitment screening, and customer lead scoring.

Companies can test agents in a sandbox environment before deployment, with complimentary introductory credits and subscription packages based on usage. The platform also provides readiness assessments and dashboards to monitor usage, costs, and performance. A dedicated administration portal enables companies to oversee their teams' use of AI agents.

The launch forms part of a wider two-year programme aimed at enabling more than 295,000 private sector companies to adopt Agentic AI technologies. This includes specialised training for 14,000 companies to support the integration of Agentic AI technologies into their operational processes.

To find out more, please visit: https://aihub.dubaichambers.com

About Dubai Chambers

Dubai Chambers is a non-profit public entity that supports Dubai’s vision as a global business hub by empowering businesses, providing innovative value-added services, and unlocking access to influential networks.

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ACMC Partners with AI Resource Intelligence Company Scepter to Evaluate Critical Minerals Projects

 (BUSINESS WIRE)--Africa Critical Minerals Corporation (ACMC) and Scepter, Inc. signed an MOU to use Scepter’s AI to evaluate African critical minerals projects for ACMC’s development platform.

ACMC is building a portfolio of critical minerals projects with local African partners. It originates opportunities, secures rights, invests, and assembles the technical, development, and capital partners to advance each project. Development partners build and operate the mines. Local content, skilled jobs, and knowledge transfer are built into every project.

ScepterAir™, Scepter’s sensor-fusion and AI anomaly detection platform, has been used in methane monitoring with ExxonMobil. The companies will integrate satellite, geological, and geospatial data to identify mineral opportunities, with field validation guiding exploration and investment.

Elias Pungong, ACMC’s Chairman, commented: “Our objective is to build a portfolio of critical minerals projects in Africa that create lasting value where we work. Partners like Scepter are key to our vision: working with cutting-edge technology companies to identify and develop the strongest opportunities in Africa.”

“We want to shorten the path from mineral identification through development and commercialization,” said Philip Father, Scepter’s Founder and CEO. “We see an extraordinary opportunity to collaborate with ACMC and its local partners to unlock the value of Africa’s mineral resources and build globally competitive critical minerals industries.”

Kweku Awotwi, mining veteran and Senior Advisor to Scepter, added, “I’m excited about the transformative potential of Scepter’s technology. AI-driven resource intelligence can fundamentally change how African nations develop their mineral resources, helping them move up the value chain.”

ACMC aims to bring American technology, capital, and expertise to African mining, including through U.S. public-private partnerships supporting technical, feasibility, and infrastructure work to attract private capital.

“U.S. national security demands earlier investment in Africa’s critical minerals,” said Carrie Clark, ACMC’s Co-founder and COO. “Scepter’s technology shows how American innovation can de-risk early-stage opportunities and open the door to American capital. We support win-win development that builds long-term prosperity in the markets we operate in.”

About Africa Critical Minerals Corporation

ACMC is a U.S.-based critical minerals development platform working with local African partners. Its founding team combines decades of African mining, energy, and project finance experience with U.S. mineral ownership and upstream development. www.africacriticalmineralscorp.com

About Scepter

Scepter, Inc. develops AI-powered resource intelligence that fuses satellite, airborne, and geological data to identify, characterize, and prioritize opportunities. www.scepterair.com

 

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TVS Motor Company Returns to EICMA With New Models for Europe

 

SINGAPORE & MILAN - 

A year after its Milan debut, TVS Motor returns with a rapidly expanding European footprint and Italian sales up 110%

Peyman Kargar to lead TVS Motor’s next phase of global growth as the company expands European footprint

 

(BUSINESS WIRE)--TVS Motor Company (TVSM), a global leader in two- and three-wheeler manufacturing, returns to EICMA in Milan this November, one year after its debut at the world’s largest two-wheeler exhibition. The company will present new models for Europe at a press conference on Tuesday, 3 November at 10:00 CET. The TVS stand is in Hall 18, Stand I64.

EICMA 2025 marked the beginning of TVS Motor's European growth journey. Since then, the company has focused on establishing the foundations for long-term success, building its dealer network, aftersales capabilities and customer support infrastructure across key markets.

In Italy, its first European market, TVS now works with around 100 dealers. Retail sales in Italy are up 110% this year to September, significantly outpacing overall market growth of around 10% and reflecting strong customer acceptance of the brand.

Expanding further within Europe, the company is establishing its own national sales companies, with operations in Italy being quickly followed by France and Germany, where TVS dealerships will open soon. Elsewhere in Europe, TVS already has 18 dealers in Spain, 2 in Portugal, 4 in Hungary and 1 in Malta. Greece and Serbia will follow by the end of 2026, and Romania by March 2027.

“Last year in Milan we said we were serious about Europe. A year later, we can demonstrate what that commitment looks like,” said Peyman Kargar, President International Business, TVS Motor Company, who has been appointed Director and Chief Executive Officer effective 27 January 2027. “We have built a strong foundation in Italy, established our own presence in key markets, and strengthened our proximity to dealers and customers. This year we return to EICMA to showcase how our product portfolio, guided by TVS Motor's enduring values of innovation, quality and customer centricity, is resonating with riders across Europe.”

TVS Motor Company serves 68 million customers in more than 90 countries. Its European operation is supported by innovation and design capability in India, Bologna and the United Kingdom.

About TVS Motor Company

TVS Motor Company (BSE:532343 and NSE: TVSMOTOR), part of TVS VENU, is a reputed two and three-wheeler manufacturer globally, championing progress through sustainable mobility with four state-of-the-art manufacturing facilities located in India and Indonesia. Rooted in our 100-year legacy of trust, value, and passion for customers, it takes pride in making internationally accepted products of the highest quality through innovative and sustainable processes. TVS Motor is the only two-wheeler company to have won the prestigious Deming Prize. Our products lead in their respective categories in the J.D. Power IQS and APEAL surveys. We have been ranked No. 1 Company in the J.D. Power Customer Service Satisfaction Survey for four consecutive years. Our group company Norton Motorcycles, based in the United Kingdom, is one of the most emotive motorcycle brands in the world. TVS Motor Company endeavours to deliver the most superior customer experience across 90 countries in which we operate.

Website:

www.tvsmotor.com

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https://www.facebook.com/tvsmotorcompany/

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https://in.linkedin.com/company/tvs-motor-company

 

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BeOne Presents Compelling Data in Hard-to-Treat Liver and Lung Cancers at ESMO 2026

 SAN CARLOS, Calif. - Saturday, 24. October 2026 AETOSWire Print 

Potential first-in-class GPC3 x 4-1BB bispecific achieves a 36% confirmed response rate at Phase 3 dose and favorable safety profile in heavily pretreated liver cancer

Brain-penetrant PRMT5 inhibitor shows promising antitumor and CNS activity in the largest publicly shared MTAP-deficient dataset

First clinical data of CEA-targeting ADC demonstrates encouraging and sustained responses in CEAhigh NSCLC

(BUSINESS WIRE) -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from multiple differentiated investigational medicines across its priority solid tumor disease areas at the European Society for Medical Oncology (ESMO) Congress 2026 (October 23–27, Madrid). The presentations span gastrointestinal, lung, and breast cancers, and reflect the growing momentum of BeOne’s solid tumor franchise.

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said:

“At ESMO, we are showing how our strategy of matching the right modality to disease biology is translating into meaningful clinical progress. Our GPC3 x 4-1BB bispecific antibody continues to be well tolerated and demonstrates durable activity with longer follow up in patients with heavily pre-treated hepatocellular carcinoma, while the first clinical data from our brain-penetrant PRMT5 inhibitor and CEA-targeting ADC expand our innovation in non-small cell lung cancer. Alongside the global Phase 3 KANDELA-302 study of our CDK4 inhibitor in breast cancer, these advances mark a clear step forward as BeOne’s solid tumor pipeline moves from promising science toward medicines with the potential to improve outcomes in difficult-to-treat cancers.”

Potential first-in-class GPC3×4-1BB bispecific continues to demonstrate compelling and durable activity in heavily pretreated HCC (Proffered Paper: 1679O; October 24, 10:15–11:45 CET)

Patients with advanced HCC who progress after immunotherapy face a high unmet need, with no established standard of care and five-year survival of only approximately 20%1,2. BGB-B2033 is an investigational bispecific antibody designed to address this gap by activating 4-1BB on T cells in the presence of GPC3-expressing tumor cells, concentrating immune activation at the tumor site, and limiting systemic toxicity, a key consideration for HCC patients who frequently suffer from underlying liver disease.

Updated Phase 1 results include the first disclosure of dose-optimization data and longer follow-up from dose escalation. Among 94 patients, 93.6% had received prior PD-(L)1 therapy and 61.7% had received both PD-(L)1 therapy and a tyrosine kinase inhibitor (TKI). Highlights include:

At the recommended Phase 3 dose of 450 mg every three weeks, the confirmed objective response rate (ORR) was 36.0%, a result that exceeds efficacy observed with TKIs, which have shown an ORR of approximately 5% in late-line HCC.3

At the selected Phase 3 dose, the estimated six-month confirmed duration-of-response rate was 74.1%, with responses observed across all clinically relevant patient subgroups.

Across dose levels, Grade 3 or higher treatment-related adverse events occurred in 5.3% of patients, and treatment-related adverse events led to discontinuation in only 2.1%.

BGB-B2033 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in December 2025, as well as Orphan Drug Designation from the FDA in March 2026 and the European Commission in October 2026 for hepatocellular carcinoma (HCC). BeOne plans to initiate global registrational clinical trials in late-line HCC by the end of 2026, while also developing plans for registrational studies in earlier treatment settings.

Initial first-in-human data from two differentiated assets advance BeOne’s emerging NSCLC portfolio

At ESMO 2026, BeOne is presenting initial clinical data in NSCLC from two biomarker-led programs with distinct mechanisms: the oral, brain-penetrant PRMT5 inhibitor, BGB-58067, and the CEA-targeting antibody-drug conjugate (ADC), BG-C477. Based on these promising data, both programs are intended to advance toward late-stage development in 2027, continuing to build BeOne’s footprint in lung cancer alongside its established program with TEVIMBRA (tislelizumab).

Brain-penetrant PRMT5 inhibitor, BGB-58067, demonstrates systemic and intracranial activity in MTAP-deficient NSCLC (Poster: 1043P; October 23, 3:15–4:00 PM CET)

BGB-58067 is a highly potent, brain-penetrant methylthioadenosine (MTA)-cooperative PRMT5 inhibitor designed to exploit the vulnerability created by MTAP deficiency. In this, the largest publicly shared data set in MTAP-deficient solid tumors, initial Phase 1 findings from 182 patients, including 83 with NSCLC, showed:

Among 75 efficacy-evaluable patients with MTAP-deficient NSCLC, confirmed ORR was 25.3% and disease control rate (DCR) was 76.0%. In the EGFR wild-type subgroup, confirmed ORR was 38.5% and DCR was 82.1%.

Median progression-free survival was 7.7 months in the overall NSCLC cohort and 8.1 months in the EGFR wild-type subgroup.

In the NSCLC cohort, an intracranial objective response rate of 30.8% was observed in patients with untreated, asymptomatic brain metastases as well as a low rate of central nervous system (CNS) progression in 2L+ NSCLC.

At daily doses of 200–400 mg (n=87), Grade 3 or higher treatment-related adverse events occurred in 27.6%, and treatment-related adverse events led to discontinuation in 5.7%. The most common treatment-related events were nausea, anemia and fatigue.

CEA-targeting ADC BG-C477 achieves encouraging response rate in previously-treated CEAhigh NSCLC (Poster: 2567P; October 26, 12:00–12:45 PM CET)

BG-C477 is the first ADC to emerge from BeOne’s internal drug discovery organization. With a proprietary CEA (or CEACAM5) targeting antibody, a highly stable conjugator, and a cleavable linker, BG-C477 is designed to deliver a potent topoisomerase I inhibitor payload directly to CEA-expressing tumor cells.

As of April 9, 2026, preliminary Phase 1 monotherapy findings from 43 heavily pretreated patients with NSCLC, including 25 with high CEA expression, showed:

Confirmed ORR was 56.0% in patients with CEAhigh NSCLC, with a disease control rate of 88.0%; confirmed ORR in the overall NSCLC population was 34.9%.

Among patients with CEAhigh NSCLC, median duration of response had not been reached. The majority of responders, as well as two patients with unconfirmed responses, remained on treatment at data cutoff.

Grade 3 or higher treatment-emergent adverse events (TEAEs) were predominantly hematologic events (anemia 14.0%, neutropenia 14.0%, thrombocytopenia 2.3%).

Updated results, with a more recent data cut-off, will be presented in the Locally Advanced NSCLC poster session on Monday, October 26 at 12:00 CET. BG-C477 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in October 2026.

Pivotal-study update: Phase 3 KANDELA-302 trial of CDK4 inhibitor BGB-43395 now enrolling in first-line HR+/HER2-negative breast cancer (1885TiP; October 24, 12:00–12:45 PM CEST)

Building on previously reported Phase 1 activity and tolerability findings, BeOne is advancing BGB-43395, an investigational selective CDK4 inhibitor, in the global Phase 3 KANDELA-302 study (NCT07492641). The study compares BGB-43395 plus letrozole with investigator’s choice of abemaciclib, palbociclib or ribociclib plus letrozole in first-line HR+/HER2-negative advanced or metastatic breast cancer.

Enrollment began in May 2026, with patients planned across North and South America, Europe, Asia and Australia. The primary endpoint is progression-free survival by blinded independent central review, with overall survival as the key secondary endpoint.

About BGB-B2033

BGB-B2033 is a bispecific antibody targeting GPC3 (glypican 3), a tumor-specific antigen highly expressed in HCC4, and 4-1BB, a co-stimulatory receptor associated with T-cell activation and tumor reactivity in HCC.5 The molecule has been designed with reduced antibody-dependent cellular cytotoxicity (ADCC) to prevent systemic toxicity.

About BGB-58067

BGB-58067 is an investigational, oral small molecule designed to inhibit protein arginine methyltransferase 5 (PRMT5) in an MTA-dependent manner, enabling selective targeting of MTAP-deleted cancer cells. Preclinical data demonstrate enhanced selectivity compared with MTAP wild-type cells, as well as strong potency and brain penetration.

About BG-C477

BG-C477 is an investigational ADC designed to target CEA, also known as CEACAM5, a protein highly expressed in several epithelial cancers, including certain lung and gastrointestinal cancers. The molecule is designed to work as a targeted delivery system, using an antibody that specifically recognizes CEA to deliver a potent anti-cancer payload to CEA-expressing tumor cells. BG-C477 incorporates a highly stable conjugator and cleavable linker, aiming for a strong bystander effect and manageable toxicity.

About BGB-43395

BGB-43395 is an investigational cyclin-dependent kinase (CDK) 4 inhibitor being studied in a global clinical development program that includes the KANDELA-302 (NCT07492641) Phase 3 clinical trial, in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. BGB-43395 is a highly potent and selective CDK4 inhibitor that may reduce dose-limiting hematologic toxicities associated with the current CDK4/6 standard of care and improve tolerability, thereby enabling deeper CDK4 inhibition.

About BeOne

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential of BGB-B2033, BGB-58067, BG-C477 and BGB-43395 to improve outcomes for patients; BeOne’s plans to initiate global registrational clinical trials of BGB-B2033 in late-line HCC by the end of 2026 and to develop registrational studies in earlier treatment settings; the expected advancement of BGB-58067 and BG-C477 toward late-stage development in 2027; the conduct and enrollment of the KANDELA-302 study; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom site.

1 Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08. PMID: 34422400; PMCID: PMC8343080.

2 National Cancer Institute. Surveillance, Epidemiology, and End Results (SEER) Program. Accessed April 2026.

3 J Clin Oncol 44, 2026 (suppl 16; abstr 4002). https://www.asco.org/abstracts-presentations/261439

4 Fanching Lin et al. Novel GPC3-targeting radiopharmaceutical therapy for hepatocellular carcinoma. J Clin Oncol 42, 525-525 (2024). DOI:10.1200/JCO.2024.42.3_suppl.525

5 Kim DY et al. 4-1BB Delineates Distinct Activation Status of Exhausted Tumor-Infiltrating CD8+ T Cells in Hepatocellular Carcinoma. Hepatology, Vol. 71, No. 3, 2020. https://onlinelibrary.wiley.com/doi/pdf/10.1002/hep.30881

 

 

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Mundipharma Announces Further Phase III ReSPECT Results Presented as a Late-Breaking Oral Presentation at IDWeek 2026

 For Trade and Medical Media Only

 

(BUSINESS WIRE)--Today Mundipharma announced additional results from the global Phase III ReSPECT clinical trial evaluating REZZAYO® (rezafungin acetate) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT). The Phase III findings were presented today as a late-breaking oral presentation at IDWeek 2026.

The presentation provides additional detail following the top line ReSPECT results announced in April 2026, including further endpoint analyses, the components contributing to fungal-free survival (FFS), pre-specified sensitivity analyses and detailed safety outcomes. The additional analyses were consistent with the previously announced topline findings.

ReSPECT was a global, multicentre, randomised, double-blind Phase III study in which 402 patients were randomised to rezafungin and 200 to the standard antimicrobial regimen. As previously announced, the study met its primary endpoint, demonstrating non-inferiority of rezafungin to the standard antimicrobial regimen for FFS at Day 90 following allo-HSCT.

The primary endpoint result was supported by six pre-specified sensitivity analyses examining the handling of indeterminate outcomes, definitions of IFD, randomisation stratification factors and the use of non-study systemic antifungal therapy.

Phase III findings were presented as a late-breaking oral presentation at IDWeek 2026

FFS at Day 90 was 60.7% with rezafungin and 59.0% with the standard antimicrobial regimen, corresponding to an estimated treatment difference of 1.6% (95% CI -6.2 to 9.3; P=0.0002 for non-inferiority)

Proven or probable IFD contributing to FFS failure occurred in 3.5% of patients receiving rezafungin versus 4.5% receiving the standard antimicrobial regimen

Data from ReSPECT have been submitted to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for regulatory review

Antifungal prophylaxis is an important component of care for patients undergoing allo-HSCT, who are at risk of life-threatening IFD. Despite established prophylactic approaches, clinical challenges can include drug toxicities, drug–drug interactions, therapeutic drug monitoring, antifungal resistance and difficulties with daily oral administration, (including adherence to antimicrobial regimens). There remains an unmet need for continued research and evidence generation to optimise prevention in this complex, immunocompromised and medically vulnerable population.2

Additional findings from ReSPECT

The composite FFS endpoint incorporated survival, absence of proven or probable IFD as assessed by an independent Data Review Committee, and no use of non-study systemic antifungal therapy for more than 10 cumulative days.

Proven or probable IFD contributing to FFS failure occurred in 3.5% of patients receiving rezafungin and 4.5% receiving the standard antimicrobial regimen. Death contributing to FFS failure occurred in 4.5% and 5.5%, respectively, while use of non-study systemic antifungal therapy for more than 10 cumulative days was numerically lower in the rezafungin group, occurring in 27.4% and 32.5%, respectively.

The study also reported IFD caused by individual fungal species. Candida infections occurred in 1.2% versus 1.0%, Aspergillus infections in 2.0% versus 3.0%, and Pneumocystis jirovecii infections in 0.2% versus 0% in the rezafungin and standard antimicrobial regimen groups, respectively.

Treatment-emergent adverse events were reported in 99.7% of patients receiving rezafungin and 100% receiving the standard antimicrobial regimen. Serious adverse events occurred in 66.0% and 67.5% of patients, respectively. Treatment-emergent adverse events leading to study discontinuation occurred in 9.3% and 14.7%, while those leading to dose reduction, interruption or withdrawal of study treatment occurred in 31.0% and 47.7%, respectively. No new safety signals were identified in allo- HSCT recipients.

“Patients undergoing allogeneic haematopoietic stem cell transplantation remain vulnerable to invasive fungal disease, and prevention is an important part of their clinical management. ReSPECT provides new Phase III evidence in this complex setting and contributes to the continuing effort to address unmet needs in antifungal prophylaxis,” said Johan Maertens, MD, PhD, University Hospitals Leuven.

“Our continued investment in the rezafungin research programme reflects Mundipharma’s commitment to advancing antifungal science and generating robust clinical evidence in areas where important unmet needs remain,” said Yuri Martina, MD, PhD, Chief Development and Medical Officer, Mundipharma. “ReSPECT is an important part of that commitment, and we are pleased to see these Phase III findings shared with the scientific community as a late-breaking oral presentation at IDWeek. We are planning to communicate progress and emerging findings through international scientific meetings including ASH, ESCMID, EHA, TIMM and EBMT, as well as through peer-reviewed publications in specialized medical journals. The submission of these data to the FDA and EMA represents another important milestone in our ongoing research programme.”

Data from the ReSPECT programme have been submitted to the FDA and EMA for regulatory review. Rezafungin prophylaxis in adults undergoing allo-HSCT represents the investigational use evaluated in ReSPECT. This prophylaxis indication is not currently approved, and approved indications for rezafungin vary by jurisdiction.

In the United States, the FDA has granted Priority Review, with a PDUFA (Prescription Drug User Fee Act) target action date in Q1 2027.

About ReSPECT

ReSPECT is a Phase III, multicentre, randomised, double-blind study comparing once-weekly intravenous rezafungin with a daily standard antimicrobial regimen for prevention of invasive fungal disease following allo-HSCT through Week 13. Adults were randomised 2:1 to rezafungin or standard antimicrobial prophylaxis.

Rezafungin was administered as a 400 mg intravenous loading dose on Day 1 followed by 200 mg once weekly. The standard antimicrobial regimen consisted of a daily oral azole, fluconazole or posaconazole, together with trimethoprim/sulfamethoxazole following engraftment.

The primary endpoint was FFS survival at Day 90 following HSCT, a composite incorporating survival, absence of proven or probable IFD, and no use of non-study systemic antifungal therapy for more than 10 cumulative days.

Regulatory status

REZZAYO® (rezafungin) is the differentiated echinocandin with a unique PK/PD profile indicated for the treatment of invasive candidiasis in adults. REZZAYO has approved indications for the treatment of Candida infections in both the United States and European Union; 4 these differ from the investigational prophylaxis setting evaluated in ReSPECT.

In the United States, REZZAYO is an echinocandin antifungal indicated in adult and paediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO.3

In the European Union, REZZAYO is indicated for the treatment of invasive candidiasis in adults. The EU Summary of Product Characteristics states that consideration should be given to official guidance on the appropriate use of antifungal agents.4

The use of rezafungin for prophylaxis of invasive fungal disease in adults undergoing allogeneic haematopoietic stem cell transplantation, as evaluated in the Phase III ReSPECT study, is investigational and is not currently an approved indication in either the United States or European Union.

About Mundipharma

Mundipharma is a global healthcare company with a presence in Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East. In line with its mission, United for Patients, Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease, ophthalmology, oncology, respiratory and central nervous system. For more information visit: www.mundipharma.com.

References:

Maertens J. et al, Rezafungin (Once Weekly) versus Standard Antimicrobial Regimen for Antifungal Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation: ReSPECT, a Multicentre, Randomized, Double-Blind, Phase III, Oral presentation at IDWeek 2026, 22 October 2026.

Quattrone M. et al, Managing Invasive Fungal Infections During Allogeneic Hematopoietic Transplantation: A 2025 Update. Mediterr J Hematol Infect Dis. 2025 Sep 1;17(1):e2025064. doi: 10.4084/MJHID.2025.064. PMID: 40937308; PMCID: PMC12422250.

HIGHLIGHTS OF PRESCRIBING INFORMATION REZZAYO https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217417s007lbl.pdf (last accessed October 2026)

Rezzayo: EPAR - Product information https://www.ema.europa.eu/en/documents/product-information/rezzayo-epar-product-information_en.pdf (last accessed October 2026)

Job Code: GBL-S-RZF-2600007

Date of preparation: October 2026

 

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media.relations@mundipharma.com

 

Galderma’s Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown Lines

 ZUG, Switzerland - Friday, 23. October 2026

The Chinese National Medical Products Administration (NMPA) has approved Relfydess™, the first and only ready-to-use liquid neuromodulator designed with PEARL™ Technology, for the temporary improvement of moderate-to-severe glabellar lines (frown lines) in adults1,2

The approval is based on phase III results from a local clinical trial conducted in China as well as global READY clinical trials, with local results reinforcing that Relfydess delivers significant improvements in frown lines, with a fast onset of action as early as day one, and sustained results for up to six months in some patients3-7

This approval underscores Galderma’s continued leadership in the Asia-Pacific region and further expands the global reach of Relfydess, which is already authorized in more than 35 markets worldwide

 

(BUSINESS WIRE)--Galderma (SIX: GALD) today announced that the Chinese NMPA has approved Relfydess for the temporary improvement of moderate-to-severe frown lines in adults, marking a significant expansion of the company’s Injectable Aesthetics portfolio in China – one of the world's largest and fastest-growing aesthetics markets.8,9 This approval follows successful authorizations and launches of Relfydess in more than 35 markets worldwide.

Relfydess is the first and only ready-to-use liquid neuromodulator developed with PEARL Technology, designed to deliver a highly active, innovative, complex-free molecule that addresses the real needs of patients and healthcare professionals.1,2,4,5 It is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10

At a time when patients and healthcare professionals are increasingly seeking high-performance neuromodulators that rapidly deliver long-lasting, natural-looking outcomes, Relfydess’ introduction to China will help to meet the increasing needs of this large and diverse market by providing an innovative new treatment option.11 Insights from a Galderma survey on anti-wrinkle treatments indicate that the market is set to expand further, with 97% of surveyed patients in China indicating they plan to maintain or increase their use in the future.11 Additionally, the survey found that 88% of Chinese patients ranked natural-looking results as one of their top three treatment benefits, and 86% ranked long lasting results up to six months in their top three.11

 

 

“Relfydess represents a breakthrough in neuromodulation, the first in decades. As a clinician, I have seen patients increasingly seek treatments that fit seamlessly into their lifestyles, delivering both rapid onset and long-lasting results. With its ready-to-use liquid formulation requiring no reconstitution, Relfydess also offers a new level of convenience and innovation. I am delighted to bring this treatment to aesthetic patients in China and help usher in a new era in neuromodulation.”

 

 

 

PROF. WU YAN

 

CHIEF PHYSICIAN OF DERMATOLOGY DEPARTMENT

 

PEKING UNIVERSITY FIRST HOSPITAL, CHINA

 

 

 

The Chinese NMPA approval is based on data from a local phase III study conducted in China, as well as the global READY (RElabotulinumtoxin Aesthetic Development studY) clinical trials, with more than 2,300 participants.3-7 Across trials, Relfydess demonstrated:

Significant improvements in frown lines, with a composite ≥2-grade improvement responder rate* at Month 1 of 82.9% in READY-1 and 72.4% in the China study vs. 0% and 1.6% for placebo, respectively3,4

Rapid onset of action, with 39% of patients reporting improvements in frown lines from day one (READY-1)4

Sustained results lasting through six months in up to 75% of patients, not returning to baseline severity (READY-1)4

Favorable safety profile, with a low incidence of treatment-related adverse events that were predominantly local or expected effects, such as injection-site reactions, headache, and eyelid ptosis3-7

*A composite responder was defined as a subject with a glabellar line severity score of 0 or 1 and an improvement of at least 2 grades from baseline on both the glabellar line investigator live assessment and glabellar line subject live assessment.

Relfydess is developed and manufactured at Galderma's Aesthetic Center of Excellence in Uppsala, Sweden, a world-class facility that reflects the company's longstanding expertise in product development, manufacturing excellence, and commitment to quality.

 

 

“The approval of Relfydess in China marks a significant milestone for Galderma and reinforces our commitment to bringing differentiated, science-based innovations to patients and healthcare professionals worldwide. With approvals in more than 35 markets globally, Relfydess continues to build strong momentum, and we are excited to now bring it to patients in China, one of the world's biggest and most dynamic aesthetics markets.”

 

 

 

FLEMMING ØRNSKOV, M.D., MPH

 

CHIEF EXECUTIVE OFFICER

 

GALDERMA

 

 

 

With Relfydess’ approval in China, Galderma expands its footprint and further strengthens its Injectable Aesthetics leadership within the fast-growing Asia-Pacific market.8,9 This milestone reinforces Galderma's long-term growth strategy and commitment to delivering scientifically proven innovation, representing another important step forward in Galderma's ambition to make Relfydess available to even more patients globally, following its authorizations in more than 35 markets, including the European Union, the United Kingdom, and Australia.

About Relfydess (relabotulinumtoxinA)

Pioneered by Galderma, Relfydess is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity.1,2 PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, creating a product that enables up to 39% of patients seeing effects from day one, and up to 75% of patients maintaining improvements for six months, based on four phase III studies from the READY clinical trial program.1,2,4-7 Relfydess is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10

Relfydess was entirely created and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. Relfydess has received marketing authorization in numerous markets. Authorization conditions may vary internationally.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References

Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting.

Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA.

Galderma. Data on File. China RelabotulinumtoxinA study. 43QMCH1908.

Shridharani SM, et al. Efficacy and safety of RelabotulinumtoxinA, a new ready-to-use liquid formulation botulinum toxin: Results from the READY-1 double-blind, randomized, placebo-controlled phase 3 trial in glabellar lines. Aesthet Surg J. 2024;44(12):1330-1340. doi: 10.1093/asj/sjae131.

Ablon G, et al. Treatment of lateral canthal lines with RelabotulinumtoxinA, an investigational liquid botulinum toxin: clinical efficacy and safety results from the READY-2 phase 3 trial. Toxicon. 2024;237(1):107353. doi: 10.1026/j.toxicon.2024.107353.

Galderma. Data on file. Clinical Study Report for Protocol 43QM1902: READY-3. Galderma Laboratories; 2021.

Galderma. Data on file. Clinical Study Report for Protocol 43AM1903: READY-4. Galderma Laboratories; 2021.

Deloitte. China Aesthetic Medicine Outlook Report. Accessed October 2026. Available online.

Grand View Horizon. China Aesthetic Medicine Market Size & Outlook, 2026-2033. Accessed October 2026. Available online.

Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Presented at: TOXINS 2024; Jan 17-20, 2024, Berlin.

Galderma. Data on File. Anti-wrinkle Treatment Aesthetic Future Survey.

 

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For further information:

Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com

+41 76 315 26 50

Richard Harbinson

Corporate Communications Director

richard.harbinson@galderma.com

+41 76 210 60 62

Céline Buguet

Franchises and R&D Communications Director

celine.buguet@galderma.com

+41 76 249 90 87

Emil Ivanov

Head of Strategy, Investor Relations, and ESG

emil.ivanov@galderma.com

+41 21 642 78 12

Jessica Cohen

Investor Relations and Strategy Director

jessica.cohen@galderma.com

+41 21 642 76 43

Lifezone Metals Confirms Advanced Negotiations with Orion CMC on Kabanga Nickel Project

 

NEW YORK - 

(BUSINESS WIRE) -- Lifezone Metals Limited (NYSE: LZM) notes comments made today by Oskar Lewnowski, Founder and Group Chief Executive of Orion Resource Partners, in an interview with Bloomberg Television regarding the Company’s Kabanga Nickel Project in Tanzania.

In response to inbound inquiries from media outlets and investors following the interview, the Company can confirm that negotiations with Orion Critical Mineral Consortium (Orion CMC) regarding a significant equity investment into the Kabanga Nickel Project are at an advanced stage.

The Orion CMC is a global investment platform launched by Orion Resource Partners in partnership with the U.S. International Development Finance Corporation (DFC) and Abu Dhabi's sovereign investor ADQ.

As previously announced, the Company has been running a competitive process, led by Standard Chartered Bank, to secure a strategic investment into the Kabanga Nickel Project.

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About Lifezone Metals

Lifezone Metals (NYSE: LZM) is committed to delivering cleaner and more responsible metals production and recycling. Through the application of our Hydromet Technology, we offer the potential for lower energy consumption, lower emissions and lower cost metals production compared to traditional smelting.

Our Kabanga Nickel Project in Tanzania is believed to be one of the world's largest and highest-grade development-ready nickel sulfide deposits. By pairing it with our Hydromet Technology, we are working to unlock a new source of nickel, copper and cobalt for the global battery metals markets and to empower Tanzania to achieve in-country beneficiation.

Through our US-based recycling partnership, we are working towards applying our Hydromet Technology to the recovery of platinum, palladium and rhodium from responsibly sourced spent automotive catalytic converters. Our process is expected to be cleaner and more efficient than conventional smelting and refining methods, supporting a circular economy for precious metals.

https://lifezonemetals.com

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These statements are subject to a number of risks and uncertainties regarding Lifezone Metals’ business, and actual results may differ materially. These risks and uncertainties include, but are not limited to: general economic, political, and business conditions, including but not limited to economic and operational disruptions; global inflation and cost increases for materials and services; capital and operating costs varying significantly from estimates; delays in obtaining or failures to obtain required governmental, environmental or other project approvals; changes in government regulations, legislation and rates of taxation; fluctuations in commodity prices; delays in the development and processing of mineral resources at the Kabanga Nickel Project; the amendment of the Framework Agreement entered into on January 19, 2021 (the “Framework Agreement”), between Kabanga Nickel Limited, a wholly-owned subsidiary of Lifezone Metals Limited, and the Government of Tanzania, and the agreement and finalization of the joint financial model relating to the Kabanga Nickel Project which will define the equitable sharing of economic benefits with government authorities in Tanzania; obtaining additional capital, including use of the debt market, future capital requirements, and sources and uses of cash; maintaining key strategic relationships with partners and customers; the timing and significance of contractual relationships; the outcome of any legal proceedings that may be instituted against Lifezone; risks related to the rollout of Lifezone’s business, the efficacy of the Hydromet Technology, and the timing of expected business milestones; the acquisition, maintenance, and protection of intellectual property; the ability of Lifezone to achieve projections and anticipate uncertainties relating to its business, operations, and financial performance, including expectations with respect to financial and business performance, future operating results, financial projections, and business metrics; expectations regarding product and technology development and pipeline, market size, and the competitive landscape; the ability to develop, design, and sell differentiated products and services; expectations regarding future acquisitions, partnerships, or other relationships with third parties; the timing and significance of contractual relationships; the effects of competition on Lifezone Metals’ business; the ability of Lifezone Metals to execute its growth strategy, the development and processing of the mineral resources at the Kabanga Nickel Project; the ability to finance the Kabanga Nickel Project; negotiations regarding the Framework Agreement and other commercial arrangements; obtaining additional capital, including use of the debt market, future capital requirements, and sources and uses of cash; the ability of Lifezone Metals to reach and maintain profitability; enhancing future operating and financial results; complying with laws and regulations applicable to Lifezone Metals’ business; and other risks that will be detailed from time to time in filings with the SEC.

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Ken Chernin

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Takeda Announces Arcotatug Tavatecan (TAK-921) Demonstrated Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Phase 3 Advanced Gastric Cancer Study

 OSAKA, Japan & CAMBRIDGE, Mass. - Friday, 23. October 2026 AETOSWire  

Data from the Registrational Phase 3 G-HOPE-001 Study of Arcotatug Tavatecan, a Novel, Potential Best-in-Class Claudin (CLDN)18.2 ADC, were Highlighted in a Late-Breaking Presentation at ESMO 2026

Arcotatug Tavatecan Met Dual Primary Endpoints of Overall Survival and Progression-Free Survival, Showing Significant Improvements vs. Treatment of Physician’s Choice in Patients with Previously Treated CLDN18.2-Positive Advanced Gastric Cancer

Findings to Support Planned Regulatory Filing in Japan and Continued Global Development of Arcotatug Tavatecan in CLDN18.2-Positive Cancers

 

(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) announced positive results from the Phase 3 G-HOPE-001 study (NCT06238843) of arcotatug tavatecan (TAK-921; Innovent R&D code: IBI343) in patients with Claudin (CLDN)18.2-positive, previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA). Results from two prespecified interim analyses, which were shared in a late-breaking oral presentation at the 2026 European Society for Medical Oncology (ESMO) Congress, showed the study met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS).

Gastric cancer is a leading cause of cancer-related death worldwide, and outcomes are particularly poor once the disease is advanced.1 Because treatment options are limited for people whose cancer continues to progress after multiple therapies, there is a significant need for new targeted therapies.2 CLDN18.2, a protein found at abnormally high levels on the surface of certain cancer cells, has emerged as a key biomarker and therapeutic target for some gastrointestinal cancers, including gastric cancer.3 Arcotatug tavatecan is a novel, potential best-in-class CLDN18.2-targeted antibody-drug conjugate (ADC) with an exatecan payload and an Fc-silenced backbone designed to reduce risk of Fc-mediated side effects. Under a license and collaboration agreement with Innovent, Takeda holds the rights to develop, manufacture and commercialize arcotatug tavatecan worldwide outside of greater China.

“People with advanced gastric cancer whose disease has progressed after multiple prior therapies face limited treatment options and poor survival outcomes,” said Kohei Shitara, M.D., Ph.D., G-HOPE-001 study author and director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. “In the Phase 3 G-HOPE-001 study, arcotatug tavatecan helped patients live longer and significantly extended the time without disease progression compared with commonly used later-line treatments. Together with its manageable safety profile, these findings highlight the potential for arcotatug tavatecan to offer meaningful clinical benefit and become an important new treatment option for patients with advanced CLDN18.2-positive gastric cancer.”

Results Signal Meaningful Benefit for Patients with Limited Options

The G-HOPE-001 study met both prespecified primary endpoints of OS and PFS, with arcotatug tavatecan demonstrating statistically significant improvements compared with treatment of physician’s choice (TPC) (irinotecan, paclitaxel or trifluridine/tipiracil).

The recently completed second prespecified interim analysis (IA2) evaluated OS. Results from IA2, with a data cutoff of September 3, 2026, showed:

Statistically significant and clinically meaningful improvement in OS. Median OS was 10.2 months with arcotatug tavatecan versus 6.9 months with TPC (HR=0.57 [95% CI: 0.45-0.73], P<0.0001).

Clinically meaningful improvement in PFS. Independent radiological review committee (IRRC)-assessed median PFS was 7.1 months with arcotatug tavatecan versus 3.1 months with TPC (HR=0.45 [95% CI: 0.35-0.58]).

Higher objective response rate (ORR). The confirmed ORR per IRRC assessment was 37.4% with arcotatug tavatecan versus 7.7% with TPC.

The overall safety profile of arcotatug tavatecan was generally manageable.

Among patients receiving arcotatug tavatecan monotherapy, the overall safety profile was manageable, with a Grade ≥3 treatment-related adverse event rate of 47.4% versus 55.9% with TPC.

The most common Grade ≥3 treatment-emergent adverse events (TEAEs) with arcotatug tavatecan versus TPC included anemia (20.4% vs. 13.1%), decreased neutrophil count (17.4% vs. 32.0%) and decreased white blood cell count (11.7% vs. 22.5%).

There was a low incidence of severe gastrointestinal events with Grade ≥3 nausea, vomiting and diarrhea occurring in 0.9%, 2.6% and 1.3% of patients receiving arcotatug tavatecan, respectively, compared with 1.8%, 3.2% and 4.1% with TPC. This characteristic of the safety profile differentiates arcotatug tavatecan and may ease this aspect of treatment burden for patients in the future.

TEAEs leading to dose interruption were reported in 47.4% of patients treated with arcotatug tavatecan versus 51.4% with TPC. Treatment-related drug discontinuations were uncommon and comparable between treatment arms, occurring in 1.7% of patients receiving arcotatug tavatecan. One treatment-related fatal adverse event, reported as sudden death of unknown cause, occurred in the arcotatug tavatecan arm.

The first prespecified interim analysis (IA1) included the final analysis of PFS and an assessment of OS futility, with a data cutoff of February 13, 2026. Results from IA1 showed:

Statistically significant and clinically meaningful improvement in PFS. IRRC-assessed median PFS was 5.5 months with arcotatug tavatecan versus 2.9 months with TPC (HR=0.47, 95% CI: 0.34-0.65; P<0.0001).

G-HOPE-001 is an international, multicenter, randomized, open-label study being conducted in China and Japan to evaluate arcotatug tavatecan monotherapy versus TPC in patients with previously treated, unresectable locally advanced or metastatic CLDN18.2-positive G/GEJA. Additional post-hoc analyses from the ongoing study will be shared at a future medical congress.

Takeda to Continue Advancing Global Development of Arcotatug Tavatecan

Data from G-HOPE-001 will support a planned regulatory filing for this indication in Japan. In China, Innovent’s New Drug Application for arcotatug tavatecan has been accepted with Priority Review by the National Medical Products Administration.

“These potentially practice-changing data from G-HOPE-001 not only support the path toward our first regulatory filing and continued global development of arcotatug tavatecan but also mark meaningful progress in translating promising science into new treatment options for patients with a range of challenging CLDN18.2-positive cancers, including gastric and pancreatic cancer,” said Phuong Khanh (P.K.) Morrow, M.D., Head of the Oncology Therapeutic Area Unit at Takeda.

Building on ongoing proof-of-concept studies in these settings, Takeda plans to initiate global Phase 3 trials of arcotatug tavatecan in gastric and pancreatic cancer.

Arcotatug tavatecan is an investigational compound that has not been approved for use by the U.S. Food and Drug Administration (FDA) or any other regulatory authorities.

About Arcotatug Tavatecan

Arcotatug tavatecan is a next-generation antibody-drug conjugate (ADC) that targets Claudin (CLDN)18.2-expressing tumor cells. CLDN18.2 is a protein typically found in the lining of a healthy stomach but is abnormally expressed on the surface of cancer cells in certain tumors, making it a target for new cancer therapies.3 Arcotatug tavatecan combines an anti-CLDN18.2 antibody with the cytotoxic agent exatecan, a topoisomerase I inhibitor (TOPO1i). It also incorporates an Fc-silenced structural design intended to minimize off-tumor, on-target toxicity.

Arcotatug tavatecan has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with CLDN18.2-positive, locally advanced or metastatic pancreatic cancer who have received two prior systemic therapies.

About the G-HOPE-001 Study

The Phase 3 G-HOPE-001 study (NCT06238843) is an ongoing, international, multicenter, randomized, open-label study evaluating arcotatug tavatecan monotherapy versus treatment of physician’s choice (TPC) (irinotecan, paclitaxel or trifluridine/tipiracil) in patients with previously treated, unresectable locally advanced or metastatic Claudin (CLDN)18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA). Eligible patients had CLDN18.2-positive tumors, defined as IHC ≥2+ in ≥75% of tumor cells as measured by the VENTANA CLDN18 (43-14A) Assay, and had progressed on two to four prior systemic regimens. Patients were randomized 1:1 to receive arcotatug tavatecan 6 mg/kg once every three weeks or TPC, stratified by region, primary tumor site and prior gastrectomy. The study’s dual primary endpoints are progression-free survival (PFS) per RECIST v1.1 and overall survival (OS). Secondary endpoints include objective response rate (ORR), disease control rate, duration of response, time to response and safety. The study enrolled 464 participants across Japan and China.

About Gastric and Gastroesophageal Junction Adenocarcinoma (G/GEJA)

Gastric cancer is the fifth most common cancer and fifth leading cause of cancer-related deaths worldwide with Japan and China among the highest-incidence regions globally.1,4 Five-year net survival rates vary globally but are approximately 20% to 40%, with markedly poorer rates in patients with advanced disease.5 Treatment options become increasingly limited as the disease progresses, and median overall survival remains less than 10 months for patients receiving later lines of therapy.6 Claudin 18.2, a tight junction protein typically found in healthy gastric tissue but abnormally expressed on the surface of tumor cells in a significant proportion of G/GEJA cancers, has emerged as an important biomarker-driven target for the development of novel precision therapies in this disease.3

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Yashima K, et al. Gastric Cancer Screening in Japan: A Narrative Review. J Clin Med. 2022;11(15):4337. doi:10.3390/jcm11154337

Rowsell A, et al. Systematic review of health-related quality of life (HRQoL) issues associated with gastric cancer: capturing cross-cultural differences. Gastric Cancer. 2022;25(4):665-677. doi:10.1007/s10120-022-01309-6

Sahin U, et al. Claudin-18 splice variant 2 is a pan-cancer target suitable for therapeutic antibody development. Clin Cancer Res. 2008;14(23):7624–7634. doi:10.1158/1078-0455.CCR-08-1547

Sung H, et al. Global cancer statistics 2024: GLOBOCAN estimates of incidence and mortality worldwide for 34 cancers in 186 countries. CA Cancer J Clin. 2026;70090. doi:10.3322/caac.70090

Allemani C, et al. Global surveillance of trends in cancer survival 2000–14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018;391(10125):1023-1075. doi:10.1016/S0140-6736(17)33326-3

Shitara K, et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric or gastro-oesophageal junction cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19(11):1437-1448. doi:10.1016/S1470-2045(18)30739-3

 

 

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Takeda U.S. and International Media

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Takeda Investor Relations

Christopher O’Reilly

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Dashen Bank and ShebaMiles Launch Platinum co-branded Mastercard Debit card to unlock premium travel benefits for customers in Ethiopia

 Dashen Bank and ShebaMiles have launched a Platinum co-branded Mastercard debit card in Ethiopia, combining secure payments, digital access, loyalty benefits and premium travel privileges in one offering.

Issued by Dashen Bank and powered by Mastercard, the card is linked to Ethiopian Airlines’ ShebaMiles loyalty program. It enables customers to use one card for everyday and travel-related payments while accessing benefits including airport lounge access, airport fast track and global data roaming, in addition to the miles they earn in the air.

The collaboration combines Ethiopian Airlines’ travel network and loyalty program, Dashen Bank’s issuing capabilities, customer reach and Super App, and Mastercard’s global payment network, technology and premium card benefits.

Shehryar Ali, senior vice president and country manager for East Africa and Indian Ocean Islands at Mastercard, said: “Travel is increasingly becoming a connected digital experience, and consumers expect the same level of convenience, security and value from the way they pay. This unique collaboration brings together payments, loyalty and premium travel benefits in a single proposition, creating a differentiated experience for travellers while strengthening Ethiopia’s premium travel payments ecosystem.”

The card will be available in physical and virtual formats. Customers can access the virtual card through the Dashen Bank Super App, which serves more than 2 million active monthly users. Eligible cardholders will also have access to Mastercard Airport Experiences, which provides entry to a global network of more than 1,600 airport lounges.

Ato Asfaw Alemu, CEO of Dashen Bank, said: “Customers today increasingly expect financial services to be more connected, convenient and relevant to the way they live and travel. Our collaboration with Mastercard and Ethiopian Airlines brings together payments, travel and loyalty in a differentiated proposition, while giving customers the flexibility to access their card digitally through the Dashen Bank Super App or through a physical card. This initiative reflects our commitment to delivering innovative, premium financial solutions that enhance the customer experience and create greater value for our customers.”

Ethiopian Airlines serves more destinations within Africa than any other airline. Connecting ShebaMiles with everyday payments and lifestyle benefits creates more opportunities for customers to engage with the airline beyond the flight and is designed to deliver ongoing value for frequent travellers, premium and diaspora customers, and digitally active consumers. It also gives Dashen Bank a differentiated offering for travel-focused customers.

The launch builds on the strategic collaboration between Mastercard and Dashen Bank, including a strategic investment agreement supporting the program’s rollout. Together, Dashen Bank and ShebaMiles are creating a digitally led payment experience that connects travel, loyalty and financial services in Ethiopia, giving customers greater choice, convenience and value throughout their journey.

About Ethiopian

Ethiopian Airlines Group (Ethiopian) is a true African success story, transforming a visionary dream into a globally renowned reality for eight decades. Operating flights to more than 160 domestic and international passenger, and cargo destinations across five continents, Ethiopian bridges the gaps between Africa and the world. Emphasizing passenger comfort and environmental sustainability, Ethiopian utilizes ultra-modern aircraft such as the Boeing 737s, 777s, 787s, Airbus A350-900, A350-1000 and De Havilland Q400.

Ethiopian, the Star Alliance member airline, champions in various coveted awards including Skytrax’s ‘Best Airline in Africa Award’ for eight consecutive years, APEX ‘Best Overall in Africa’ award and ‘Leadership in Connecting Africa through Transport’ Award among others. Ethiopian aims to further excel in its success through a strategic vision and become one of the top 20 most competitive and leading aviation groups in the world. Embracing a Pan-African spirit, Ethiopian is pursuing multi-hub strategy through hubs in Lomé, Togo with ASKY, in Lilongwe, Malawi with Malawi Airlines, in Lusaka, Zambia with Zambia Airways, and in Kinshasa, Democratic Republic of the Congo (DRC) with Air Congo.

For more information, visit our website at www.ethiopianairlines.com  email us at CorporateCommunication@ethiopianairlines.com , or call us at (251-11)517-8913/8165/8907.

About Dashen Bank

Headquartered in Addis Ababa, Dashen Bank is one of Ethiopia’s leading private banks and among the country’s most trusted banking brands, with a nationwide network of 900+ branches, 9 dedicated Forex Bureaus, 1,100+ ATMs, and 2,000+ POS terminals. Through its omnichannel banking ecosystem, Dashen provides customers with convenient access to digital payments, banking services, and a wide range of lifestyle and third-party services. At the heart of this digital transformation is the Dashen Bank Super App, Ethiopia’s first banking super app, which brings personal banking, business, and lifestyle solutions together in one secure and seamless platform, serving more than 2 million active monthly users. More at https://dashenbanksc.com/

About Mastercard

Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we’re building a resilient economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential.

www.mastercard.com

 

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BeOne Medicines Reports Sustained Survival Benefit with TEVIMBRA-ZIIHERA Combination in First-Line HER2+ Gastroesophageal Cancer

 SAN CARLOS, Calif. - Friday, 23. October 2026 AETOSWire  

New data from HERIZON-GEA-01 Phase 3 trial show 36-month overall survival of nearly 40% with TEVIMBRA plus ZIIHERA and chemotherapy, and median OS reaching 27 months

TEVIMBRA-containing arm was associated with a four-month longer median OS compared with ZIIHERA plus chemotherapy

(BUSINESS WIRE) -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new survival results from the planned second interim analysis (IA2) and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA® (tislelizumab) plus ZIIHERA® (zanidatamab) and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (LBA79).

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said:

“Following the U.S. approval in August, these longer-term data provide further evidence supporting TEVIMBRA plus ZIIHERA and chemotherapy as the new standard of care in all first-line HER2-positive advanced gastroesophageal adenocarcinoma patients, regardless of PD-L1 status. The magnitude of the survival benefit previously demonstrated with TEVIMBRA plus ZIIHERA and chemotherapy versus trastuzumab plus chemotherapy increased after longer follow-up, with nearly 40% of patients receiving the TEVIMBRA-containing regimen alive at three years, representing a compelling result in this challenging disease area.”

Longer follow-up reinforces benefit of TEVIMBRA in combination regimen

This new analysis was conducted after 35.3 months of follow-up, an additional 9.4 months since the first interim analysis. Formal overall survival (OS) comparisons were tested sequentially, first comparing ZIIHERA plus chemotherapy with trastuzumab plus chemotherapy and then comparing TEVIMBRA plus ZIIHERA and chemotherapy with ZIIHERA plus chemotherapy.

Key findings include:

TEVIMBRA plus ZIIHERA and chemotherapy demonstrated sustained long-term survival versus trastuzumab plus chemotherapy. Median OS was 27.0 months, with an OS hazard ratio (HR) of 0.65 (95% CI: 0.52-0.80), improved from 0.72 at the first interim analysis. This regimen is the only treatment for patients with HER2+ GEA to show a median overall survival of more than two years.

ZIIHERA plus chemotherapy significantly improved OS versus trastuzumab plus chemotherapy. Median OS was 22.9 months versus 19.6 months, respectively (HR 0.76; 95% CI: 0.62-0.93; P=0.0088), meeting the remaining primary endpoint of the study.

Adding TEVIMBRA to ZIIHERA plus chemotherapy was associated with a four-month longer median OS at 27.0 months compared with ZIIHERA plus chemotherapy with 22.9 months (HR 0.81; 95% CI: 0.65-1.00). The difference did not reach statistical significance (P=0.0502) in the context of an underpowered analysis. A consistent trend toward improved OS was observed irrespective of PD-L1 status (PD-L1 TAP<1% HR 0.76; 95% CI: 0.52-1.10; PD-L1 TAP≥1% HR 0.77; 95% CI: 0.58-1.02).

Long-term survival was highest with the TEVIMBRA-containing regimen. Estimated 36-month OS was 39.8% with TEVIMBRA plus ZIIHERA and chemotherapy, 31.5% with ZIIHERA plus chemotherapy and 22.9% with trastuzumab plus chemotherapy.

TEVIMBRA plus ZIIHERA and chemotherapy significantly improved progression-free survival (PFS) versus trastuzumab plus chemotherapy, with median PFS of 12.7 months versus 8.3 months (HR 0.61; 95% CI:0.5-0.76). Median PFS with ZIIHERA plus chemotherapy was 12.4 months versus trastuzumab plus chemotherapy (HR 0.65; 95% CI:0.5-0.76).

The safety findings for both experimental arms were generally consistent with the first interim analysis, and with the known profiles of the component therapies. No new safety signals were identified, and diarrhea was the most common Grade ≥3 treatment-related adverse event (TRAE). A mandatory anti-diarrheal prophylaxis was established during the first cycle, with most diarrhea events occurring early in the treatment.

About the HERIZON-GEA-01 Phase 3 Trial

HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with Jazz Pharmaceuticals, to evaluate and compare the efficacy and safety of ZIIHERA plus chemotherapy, with and without TEVIMBRA, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: ZIIHERA in combination with chemotherapy and TEVIMBRA; ZIIHERA in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial evaluated dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About ZIIHERA (zanidatamab-hrii)

ZIIHERA (zanidatamab-hrii) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the cornerstone asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved for various solid tumors (see prescribing information) in over 50 countries, and more than 2.2 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

About BeOne

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential of the HERIZON-GEA-01 regimens as a standard of care for first-line HER2-positive GEA; ongoing clinical development of zanidatamab and TEVIMBRA across multiple tumor types and disease settings; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom site.

___________________________________

1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.

 

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