Latest news with #BeOneMedicines
Business Insider
7 hours ago
- Business
- Business Insider
BeOne Medicines to present new data from Phase 3 SEQUOIA trial of BRUKINSA
BeOne Medicines (ONC) will present new data from the Arm C and D cohorts of the pivotal, global Phase 3 SEQUOIA trial of BRUKINSA. These data will be presented in two rapid oral presentations at the American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago, IL. Data from the Arm D of SEQUOIA demonstrate that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. The best undetectable minimal residual disease rate in peripheral blood at a sensitivity level 10-4 was 59%. These efficacy responses observed in Arm D, despite the high proportion of high-risk patients enrolled, are in line with recent fixed-duration studies in fitter, healthier patient populations. Additionally, 11 patients in Arm D were able to discontinue treatment early due to meeting uMRD-guided stopping criteria, and 9 patients remain in ongoing clinical remission with sustained uMRD, allowing them to remain treatment-free. In patients without del(17p) and TP53 mutations, 43% achieved uMRD by cycle 16 and 60% by cycle 28. These data were published today in the Journal of Clinical Oncology. Confident Investing Starts Here:
National Post
2 days ago
- Business
- National Post
BeOne Medicines Presents New SEQUOIA Study Results Reinforcing BRUKINSA's Differentiated Profile with or without Venetoclax in Frontline CLL at ASCO 2025
Article content BRUKINSA plus venetoclax demonstrated high response rates and a favorable safety profile across CLL patient types in SEQUOIA Arm D, including those with high-risk del(17p) mutational status Article content Article content At 5-year follow-up of SEQUOIA Arm C, BRUKINSA monotherapy showed sustained OS and PFS benefit in hard-to-treat del(17p) CLL patients versus historical data Article content SAN CARLOS, Calif. — BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today will present new data from the Arm C and D cohorts of the pivotal, global Phase 3 SEQUOIA trial of BRUKINSA ® (zanubrutinib). The findings underscore the strong and consistent efficacy of BRUKINSA across CLL patient types, including high-risk mutation status. These data will be presented in two rapid oral presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL. Article content Data from the Arm D of SEQUOIA demonstrate that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. The best undetectable minimal residual disease (uMRD) rate in peripheral blood at a sensitivity level 10 -4 was 59%. These efficacy responses observed in Arm D, despite the high proportion of high-risk patients enrolled, are in line with recent fixed-duration studies in fitter, healthier patient populations. Additionally, 11 patients in Arm D were able to discontinue treatment early due to meeting uMRD-guided stopping criteria, and 9 patients remain in ongoing clinical remission with sustained uMRD (1 patient discontinued study while in clinical remission), allowing them to remain treatment-free. In patients without del(17p) and TP53 mutations, 43% achieved uMRD by cycle 16 and 60% by cycle 28. These data were published today in the Journal of Clinical Oncology. Article content 'While many first-line CLL studies have excluded patient populations with high-risk disease features, BeOne included those patients in SEQUOIA,' said Lai Wang, Ph.D., Global Head of R&D at BeOne. 'Nearly 88% of patients with del(17p) and /or TP53 treated with BRUKINSA plus venetoclax remain progression-free at 36 months, which represents an unprecedented outcome for a doublet regimen in this difficult-to-treat patient population. These new SEQUOIA data reinforce BRUKINSA's versatility across the spectrum of CLL patients and reflect BeOne's commitment to progressing a pipeline built to meet unmet patient needs and elevate the standard of care.' Article content Arm D Highlights (Abstract 7009) SEQUOIA Arm D investigated BRUKINSA plus venetoclax in 114 patients with treatment-naïve (TN) CLL / small lymphocytic lymphoma (SLL) with or without del(17p) and/or TP53 high-risk mutations. At a median follow-up of 31.2 months, the combination induced a high 24-month progression-free survival (PFS) rate of 92% (95% CI, 85-96%) and an impressive overall response rate (ORR) of 97%. The 24-month overall survival (OS) rate was 96% (95% CI, 90%-98%). Of those patients with del(17p) and/or TP53 mutations, 94% were progression-free at 24 months and 87.6% were progression-free at 36 months. Article content The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. Article content 'The zanubrutinib and venetoclax combination achieved deep, durable responses across risk groups, including patients with TP53 mutations, with a generally manageable safety profile. Notably, several patients were able to discontinue treatment and maintain remission, highlighting the potential for time-limited therapy with meaningful disease control,' said Mazyar Shadman, M.D., M.P.H., Associate Professor and Innovators Network Endowed Chair, Medical Director, Cellular Immunotherapy and the Bezos Family Immunotherapy Clinic at Fred Hutch Cancer Center. 'Generating data to inform future CLL treatment strategies that allow for both continuous therapy and planned time off treatment is essential, particularly for high-risk patients who are the most likely to succumb to this disease.' Article content Arm C Highlights (Abstract 7011) Arm C of the SEQUOIA study investigated BRUKINSA monotherapy in patients with TN CLL / SLL and del(17p) mutations and is the largest prospective cohort of CLL/SLL patients with del(17p). At a median follow-up of over 5.5 years (65.8 months), most patients remained progression-free. Notably, at 60 months, 72.2% of patients who received BRUKINSA remained progression-free (95% CI, 62.4, 79.8). When adjusted for the impact of the COVID-19 pandemic, 73.0% of patients in the cohort remained progression-free (95% CI, 63.3, 80.6) at 60 months. The 60-month OS rate was 85.1% (95% CI, 76.9, 90.6) and 87.0% (95% CI, 79.0, 92.1) when adjusted for COVID-19. At the time of data cut-off, the ORR was 97.3%, and 62.2% of patients were still receiving treatment with BRUKINSA. Article content The safety profile of BRUKINSA was consistent with the results of prior studies with no new safety signals identified. Article content For additional information about our presence at the 2025 ASCO Annual Meeting, please visit our meeting hub: Article content About Chronic Lymphocytic Leukemia Chronic lymphocytic leukemia (CLL) is a life-threatening cancer of adults. It is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues. 1,2 CLL is the most common type of leukemia in adults, accounting for about one-third of new cases. 2,3 Approximately 20,700 new cases of CLL will be diagnosed in the U.S. in 2024. 3 Article content About 50% of CLL patients have high-risk genetic features – including del(17p), TP53 or unmutated IGHV – that may limit the effectiveness of some treatments (e.g. chemotherapy) and increase the likelihood of disease progression. 4,5 Article content About SEQUOIA SEQUOIA ( NCT03336333) is a randomized, multicenter, global Phase 3 trial designed to evaluate the efficacy and safety of BRUKINSA in patients with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The trial consists of three cohorts: Article content Cohort 1 (n=479): randomized 1:1 to receive BRUKINSA (n=241) or bendamustine plus rituximab (n=238) until disease progression or unacceptable toxicity, in patients not harboring del(17p); data from this group comprise the primary endpoint; Cohort 2/Arm C (n=110): patients with del(17p) receiving BRUKINSA as a monotherapy; and Cohort 3/Arm D (n=114): 66 patients with del(17p) and/or pathogenic TP53 mutation and 47 patients without del(17p) or TP53 were enrolled, with 110 patients receiving BRUKINSA in combination with venetoclax. Article content The results of Cohort 1 of the SEQUOIA study led to the regulatory approval of BRUKINSA monotherapy in the treatment of TN CLL in many countries across the world, including approvals by the U.S. Food and Drug Administration and the European Medicines Agency. The primary endpoint of the trial is progression-free survival (PFS), as assessed by an independent review committee (IRC). Secondary endpoints include investigator-assessed PFS, IRC- and investigator-assessed overall response rate (ORR), overall survival (OS), and safety, as well as PFS and ORR in patients with del(17p). Article content About BRUKINSA ® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. Article content BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets, and more than 200,000 patients have been treated globally. Article content Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström's macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. Article content The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Article content Hemorrhage Article content Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Article content Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Article content Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Article content Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Article content Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Article content Cytopenias Article content Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Article content Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Article content Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Article content Cardiac Arrhythmias Article content Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Article content Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Article content Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Article content Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Article content Embryo-Fetal Toxicity Article content Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Article content Adverse Reactions Article content The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Article content Drug Interactions Article content CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Article content About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to 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. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Article content Forward-Looking Statements 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 BeOne's ability to deliver advanced and effective treatments for a broad range of cancer patients; BRUKINSA's role across CLL patients; the ability of BeOne's pipeline to meeting evolving patient needs and elevate the standard of care; 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; BeOne's ability to obtain additional funding for operations and to complete the development of its drug candidates 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. Article content _______________________________ 1 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version. Accessed November 2024. 2 American Cancer Society. What is Chronic Lymphocytic Leukemia? Updated May 10, 2018. Accessed November 2024. 3 American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Updated July 1, 2024. Accessed November 2024. 4 Leukemia and Lymphoma Society. Chronic Lymphocytic Leukemia. Revised June 2021. Accessed November 5, 2024. Article content Article content Article content Article content Article content Contacts Article content Article content Article content
Yahoo
3 days ago
- Business
- Yahoo
Zymeworks Announces NMPA Approval of Zanidatamab in China for Adults with Previously Treated, Unresectable or Metastatic HER2-high expression (IHC3+) Biliary Tract Cancer
Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2+ biliary tract cancer in China; conditional approval based on the results of the HERIZON-BTC-01 clinical study $20 million milestone payment to be received from BeOne Medicines; Zymeworks remains eligible to receive up to $144 million in additional development and commercial milestones VANCOUVER, British Columbia, May 30, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). The conditional approval marks the first and only1 dual HER2-targeted bispecific antibody approved for HER2-high expression (IHC3+) BTC in China. Zymeworks' collaboration partner, BeOne Medicines Ltd. (formerly BeiGene, Ltd), obtained the conditional approval under the terms of its Asia Pacific license and collaboration agreement with Zymeworks. Continued approval of this indication will depend on the verification of clinical benefit in the patient population through ongoing confirmatory trials. 'Zanidatamab's conditional approval in China is a meaningful advancement for patients living with HER2-positive BTC, a population with historically high unmet need and poor prognoses,' said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. 'This milestone affirms the strength of zanidatamab's clinical potential and reflects our continued focus on translating innovation into real impact for patients around the globe. We are deeply grateful to our partners at BeOne Medicines, and to the patients, families, and clinical teams whose contributions have made this milestone a reality. As Zymeworks continues to advance our broader development programs and R&D pipeline, we remain committed to realizing zanidatamab's potential to transform the standard of care across HER2-expressing cancers.' Under the terms of its agreement with BeOne Medicines, Zymeworks has received $61 million in upfront and milestone payments, as well as certain co-development funding for zanidatamab clinical studies. Zymeworks is entitled to receive a $20 million milestone payment in connection with the NMPA approval of zanidatamab, and is eligible to receive up to $144 million in additional development and commercial milestones. Zymeworks is also eligible to receive tiered royalties of up to 19.5% of net sales in BeOne Medicine's territories. Zanidatamab was approved by the U.S. Food and Drug Administration (FDA) in November 2024 for the treatment of adults with previously treated, unresectable or metastatic HER2+ (IHC 3+) BTC. In April 2025, Zymeworks' partner, Jazz Pharmaceuticals, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of zanidatamab for the treatment of advanced HER2+ BTC. About Biliary Tract Cancer Biliary tract cancers (BTC), including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, account for approximately 3% of all digestive system tumors and are often associated with a poor prognosis2,3,4. Approximately 11%-25.2% of patients with BTC are HER2-positive5,6,7. The human epidermal growth factor receptor 2 (HER2) is a well-validated target for antitumor therapy in other cancers3,8. The incidence rate of BTC is on the rise globally, in particular in Asian countries and regions.9 About zanidatamab Zanidatamab is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the 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 tumor cell death.10 About Zymeworks Inc. Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks' mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company's complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company's proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval and China's NMPA granted conditional approval for zanidatamab to treat adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. and China. Zanidatamab is currently under regulatory review in the EU for second-line BTC and is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are now actively recruiting with an investigational new drug application for ZW251 planned for mid-2025. In addition to Zymeworks' pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes 'forward-looking statements' or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the efficacy and safety of zanidatamab; ongoing clinical studies and regulatory reviews; the anticipated benefits of the collaboration agreement with BeOne Medicines, including Zymeworks' ability to receive any future milestone payments and royalties thereunder; the potential addressable market of zanidatamab; the timing of and results of interactions with regulators; Zymeworks' clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies and the related data; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab; the commercial potential of technology platforms and product candidates; Zymeworks' ability to satisfy potential regulatory and commercial milestones with existing and future partners and anticipated continued receipt of revenue from existing and future partners. When used herein, words such as 'plan', 'believe', 'expect', 'may', 'anticipate', 'potential', 'will', 'continues', and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks' current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials, including any required confirmatory trials, may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; any of Zymeworks' or its partners' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; conditional regulatory approval may be withdrawn or revoked if any of Zymeworks' or its partners' product candidates fail to satisfy the requirements of any such conditional regulatory approvals; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks' business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks' behalf; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under 'Risk Factors' in Zymeworks' quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Investor inquiries:Shrinal InamdarSenior Director, Investor Relations(604) 678-1388ir@ Media inquiries:Diana PapoveSenior Director, Corporate Communications (604) 678-1388media@ _________________________________ 1 According to publicly available information, as of the approval announcement on May 29, 2025, zanidatamab is the only HER2-targeting bispecific antibody approved by the National Medical Products Administration (NMPA) for HER2-high-expression biliary tract cancer (BTC).2 Chinese Society of Clinical Oncology (CSCO). Diagnosis and Treatment Guidelines for Biliary Malignant Tumors (2024).3 Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up. Ann Oncol. 2023;34(2):127-40. doi:10.1016/ Chakrabarti, S., Choong-kun Lee, et al. 2025 ASCO GI Abstr. #629.6 Hiraoka N, et al. Hum Pathol. 2020 Nov:105:9-19.7 Vivaldi C, et al. Oncologist. 2020 Oct;25(10):886-893.8 Meric-Bernstam, F., Beeram, et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: a phase 1, dose-escalation and expansion study. The Lancet Oncology. 2022; doi: 10.1016/S1470-2045(22)00621-0.9 Chinese Society of Clinical Oncology (CSCO) Biliary Tumor Expert Committee Expert consensus on precise detection and molecular diagnosis of biliary malignant tumors [J]. Journal of Clinical Oncology, 2024, 29 (8): 797-804.10 Weisser NE, Sanches M, Escobar-Cabrera E et al. An anti-HER2 biparatopic antibody that induces unique HER2 clustering and complement-dependent cytotoxicity. Nature Communications. 2023 Mar 13;14(1):1394. doi: 10.1038/ while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Upturn
3 days ago
- Business
- Business Upturn
Zymeworks Announces NMPA Approval of Zanidatamab in China for Adults with Previously Treated, Unresectable or Metastatic HER2-high expression (IHC3+) Biliary Tract Cancer
Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2+ biliary tract cancer in China; conditional approval based on the results of the HERIZON-BTC-01 clinical study $20 million milestone payment to be received from BeOne Medicines; Zymeworks remains eligible to receive up to $144 million in additional development and commercial milestones VANCOUVER, British Columbia, May 30, 2025 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). The conditional approval marks the first and only1 dual HER2-targeted bispecific antibody approved for HER2-high expression (IHC3+) BTC in China. Zymeworks' collaboration partner, BeOne Medicines Ltd. (formerly BeiGene, Ltd), obtained the conditional approval under the terms of its Asia Pacific license and collaboration agreement with Zymeworks. Continued approval of this indication will depend on the verification of clinical benefit in the patient population through ongoing confirmatory trials. Advertisement 'Zanidatamab's conditional approval in China is a meaningful advancement for patients living with HER2-positive BTC, a population with historically high unmet need and poor prognoses,' said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. 'This milestone affirms the strength of zanidatamab's clinical potential and reflects our continued focus on translating innovation into real impact for patients around the globe. We are deeply grateful to our partners at BeOne Medicines, and to the patients, families, and clinical teams whose contributions have made this milestone a reality. As Zymeworks continues to advance our broader development programs and R&D pipeline, we remain committed to realizing zanidatamab's potential to transform the standard of care across HER2-expressing cancers.' Under the terms of its agreement with BeOne Medicines, Zymeworks has received $61 million in upfront and milestone payments, as well as certain co-development funding for zanidatamab clinical studies. Zymeworks is entitled to receive a $20 million milestone payment in connection with the NMPA approval of zanidatamab, and is eligible to receive up to $144 million in additional development and commercial milestones. Zymeworks is also eligible to receive tiered royalties of up to 19.5% of net sales in BeOne Medicine's territories. Zanidatamab was approved by the U.S. Food and Drug Administration (FDA) in November 2024 for the treatment of adults with previously treated, unresectable or metastatic HER2+ (IHC 3+) BTC. In April 2025, Zymeworks' partner, Jazz Pharmaceuticals, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of zanidatamab for the treatment of advanced HER2+ BTC. About Biliary Tract Cancer Biliary tract cancers (BTC), including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, account for approximately 3% of all digestive system tumors and are often associated with a poor prognosis2,3,4. Approximately 11%-25.2% of patients with BTC are HER2-positive5,6,7. The human epidermal growth factor receptor 2 (HER2) is a well-validated target for antitumor therapy in other cancers3,8. The incidence rate of BTC is on the rise globally, in particular in Asian countries and regions.9 About zanidatamab Zanidatamab is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the 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 tumor cell death.10 About Zymeworks Inc. Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks' mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company's complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company's proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval and China's NMPA granted conditional approval for zanidatamab to treat adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. and China. Zanidatamab is currently under regulatory review in the EU for second-line BTC and is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are now actively recruiting with an investigational new drug application for ZW251 planned for mid-2025. In addition to Zymeworks' pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes 'forward-looking statements' or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the efficacy and safety of zanidatamab; ongoing clinical studies and regulatory reviews; the anticipated benefits of the collaboration agreement with BeOne Medicines, including Zymeworks' ability to receive any future milestone payments and royalties thereunder; the potential addressable market of zanidatamab; the timing of and results of interactions with regulators; Zymeworks' clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies and the related data; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab; the commercial potential of technology platforms and product candidates; Zymeworks' ability to satisfy potential regulatory and commercial milestones with existing and future partners and anticipated continued receipt of revenue from existing and future partners. When used herein, words such as 'plan', 'believe', 'expect', 'may', 'anticipate', 'potential', 'will', 'continues', and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks' current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials, including any required confirmatory trials, may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; any of Zymeworks' or its partners' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; conditional regulatory approval may be withdrawn or revoked if any of Zymeworks' or its partners' product candidates fail to satisfy the requirements of any such conditional regulatory approvals; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks' business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks' behalf; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under 'Risk Factors' in Zymeworks' quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Investor inquiries: Shrinal Inamdar Senior Director, Investor Relations (604) 678-1388 [email protected] Media inquiries: Diana Papove Senior Director, Corporate Communications (604) 678-1388 [email protected] _________________________________ 1 According to publicly available information, as of the approval announcement on May 29, 2025, zanidatamab is the only HER2-targeting bispecific antibody approved by the National Medical Products Administration (NMPA) for HER2-high-expression biliary tract cancer (BTC). 2 Chinese Society of Clinical Oncology (CSCO). Diagnosis and Treatment Guidelines for Biliary Malignant Tumors (2024). 3 Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up. Ann Oncol. 2023;34(2):127-40. doi:10.1016/ 4 Chakrabarti, S., 5 Choong-kun Lee, et al. 2025 ASCO GI Abstr. #629. 6 Hiraoka N, et al. Hum Pathol. 2020 Nov:105:9-19. 7 Vivaldi C, et al. Oncologist. 2020 Oct;25(10):886-893. 8 Meric-Bernstam, F., Beeram, et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: a phase 1, dose-escalation and expansion study. The Lancet Oncology. 2022; doi: 10.1016/S1470-2045(22)00621-0. 9 Chinese Society of Clinical Oncology (CSCO) Biliary Tumor Expert Committee Expert consensus on precise detection and molecular diagnosis of biliary malignant tumors [J]. Journal of Clinical Oncology, 2024, 29 (8): 797-804. 10 Weisser NE, Sanches M, Escobar-Cabrera E et al. An anti-HER2 biparatopic antibody that induces unique HER2 clustering and complement-dependent cytotoxicity. Nature Communications. 2023 Mar 13;14(1):1394. doi: 10.1038/s41467-023-37029-3. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
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Zymeworks Announces NMPA Approval of Zanidatamab in China for Adults with Previously Treated, Unresectable or Metastatic HER2-high expression (IHC3+) Biliary Tract Cancer
Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2+ biliary tract cancer in China; conditional approval based on the results of the HERIZON-BTC-01 clinical study $20 million milestone payment to be received from BeOne Medicines; Zymeworks remains eligible to receive up to $144 million in additional development and commercial milestones VANCOUVER, British Columbia, May 30, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). The conditional approval marks the first and only1 dual HER2-targeted bispecific antibody approved for HER2-high expression (IHC3+) BTC in China. Zymeworks' collaboration partner, BeOne Medicines Ltd. (formerly BeiGene, Ltd), obtained the conditional approval under the terms of its Asia Pacific license and collaboration agreement with Zymeworks. Continued approval of this indication will depend on the verification of clinical benefit in the patient population through ongoing confirmatory trials. 'Zanidatamab's conditional approval in China is a meaningful advancement for patients living with HER2-positive BTC, a population with historically high unmet need and poor prognoses,' said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks. 'This milestone affirms the strength of zanidatamab's clinical potential and reflects our continued focus on translating innovation into real impact for patients around the globe. We are deeply grateful to our partners at BeOne Medicines, and to the patients, families, and clinical teams whose contributions have made this milestone a reality. As Zymeworks continues to advance our broader development programs and R&D pipeline, we remain committed to realizing zanidatamab's potential to transform the standard of care across HER2-expressing cancers.' Under the terms of its agreement with BeOne Medicines, Zymeworks has received $61 million in upfront and milestone payments, as well as certain co-development funding for zanidatamab clinical studies. Zymeworks is entitled to receive a $20 million milestone payment in connection with the NMPA approval of zanidatamab, and is eligible to receive up to $144 million in additional development and commercial milestones. Zymeworks is also eligible to receive tiered royalties of up to 19.5% of net sales in BeOne Medicine's territories. Zanidatamab was approved by the U.S. Food and Drug Administration (FDA) in November 2024 for the treatment of adults with previously treated, unresectable or metastatic HER2+ (IHC 3+) BTC. In April 2025, Zymeworks' partner, Jazz Pharmaceuticals, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of zanidatamab for the treatment of advanced HER2+ BTC. About Biliary Tract Cancer Biliary tract cancers (BTC), including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, account for approximately 3% of all digestive system tumors and are often associated with a poor prognosis2,3,4. Approximately 11%-25.2% of patients with BTC are HER2-positive5,6,7. The human epidermal growth factor receptor 2 (HER2) is a well-validated target for antitumor therapy in other cancers3,8. The incidence rate of BTC is on the rise globally, in particular in Asian countries and regions.9 About zanidatamab Zanidatamab is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the 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 tumor cell death.10 About Zymeworks Inc. Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks' mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company's complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company's proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. The U.S. FDA granted accelerated approval and China's NMPA granted conditional approval for zanidatamab to treat adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. Zanidatamab is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. and China. Zanidatamab is currently under regulatory review in the EU for second-line BTC and is being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody-drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Phase 1 studies for ZW171 and ZW191 are now actively recruiting with an investigational new drug application for ZW251 planned for mid-2025. In addition to Zymeworks' pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit and follow @ZymeworksInc on X. Cautionary Note Regarding Forward-Looking Statements This press release includes 'forward-looking statements' or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the efficacy and safety of zanidatamab; ongoing clinical studies and regulatory reviews; the anticipated benefits of the collaboration agreement with BeOne Medicines, including Zymeworks' ability to receive any future milestone payments and royalties thereunder; the potential addressable market of zanidatamab; the timing of and results of interactions with regulators; Zymeworks' clinical development of its product candidates and enrollment in its clinical trials; the timing and status of ongoing and future studies and the related data; expectations regarding future regulatory filings and approvals and the timing thereof; potential safety profile and therapeutic effects of zanidatamab; the commercial potential of technology platforms and product candidates; Zymeworks' ability to satisfy potential regulatory and commercial milestones with existing and future partners and anticipated continued receipt of revenue from existing and future partners. When used herein, words such as 'plan', 'believe', 'expect', 'may', 'anticipate', 'potential', 'will', 'continues', and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks' current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials, including any required confirmatory trials, may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; any of Zymeworks' or its partners' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; conditional regulatory approval may be withdrawn or revoked if any of Zymeworks' or its partners' product candidates fail to satisfy the requirements of any such conditional regulatory approvals; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks' business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks' behalf; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks' or its collaborators' product candidates; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under 'Risk Factors' in Zymeworks' quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at and Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events. Investor inquiries:Shrinal InamdarSenior Director, Investor Relations(604) 678-1388ir@ Media inquiries:Diana PapoveSenior Director, Corporate Communications (604) 678-1388media@ _________________________________ 1 According to publicly available information, as of the approval announcement on May 29, 2025, zanidatamab is the only HER2-targeting bispecific antibody approved by the National Medical Products Administration (NMPA) for HER2-high-expression biliary tract cancer (BTC).2 Chinese Society of Clinical Oncology (CSCO). Diagnosis and Treatment Guidelines for Biliary Malignant Tumors (2024).3 Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up. Ann Oncol. 2023;34(2):127-40. doi:10.1016/ Chakrabarti, S., Choong-kun Lee, et al. 2025 ASCO GI Abstr. #629.6 Hiraoka N, et al. Hum Pathol. 2020 Nov:105:9-19.7 Vivaldi C, et al. Oncologist. 2020 Oct;25(10):886-893.8 Meric-Bernstam, F., Beeram, et al. Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: a phase 1, dose-escalation and expansion study. The Lancet Oncology. 2022; doi: 10.1016/S1470-2045(22)00621-0.9 Chinese Society of Clinical Oncology (CSCO) Biliary Tumor Expert Committee Expert consensus on precise detection and molecular diagnosis of biliary malignant tumors [J]. Journal of Clinical Oncology, 2024, 29 (8): 797-804.10 Weisser NE, Sanches M, Escobar-Cabrera E et al. An anti-HER2 biparatopic antibody that induces unique HER2 clustering and complement-dependent cytotoxicity. Nature Communications. 2023 Mar 13;14(1):1394. doi: 10.1038/ in to access your portfolio
