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Zymeworks Announces China NMPA Acceptance of Biologics License Application for Zanidatamab for Second-Line Treatment of Biliary Tract Cancer
Pursuant to the terms of the licensing agreement between Zymeworks and BeiGene, Zymeworks is entitled to receive an $8 million milestone payment from BeiGene
About this update from Zymeworks Inc.
[{"type":"text","content":"Pursuant to the terms of the licensing agreement between Zymeworks and BeiGene, Zymeworks is entitled to receive an $8 million milestone payment from BeiGene and remains eligible to receive up to $164 million based on additional milestones plus royalties on product salesA Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for zanidatamab as a treatment for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) has also been recently accepted for Priority Review by the FDA with target action date of November 29, 2024 VANCOUVER, British Columbia, June 10, 2024 (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, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has accepted the BLA for zanidatamab for second-line treatment of HER2-positive BTC. Under the terms of Zymeworks’ Asia Pacific license and collaboration agreement with BeiGene for the development and commercialization of zanidatamab, Zymeworks is entitled to receive an $8 million milestone payment. Zymeworks also remains eligible to receive up to $164 million based on additional milestones plus royalties on product sales in the Asia Pacific region. This BLA is based on the data from the HERIZON-BTC-01 (NCT04466891, CTR20202607) clinical trial, which was published in Lancet Oncology in June 20231. The trial is an open-label phase 2b study that evaluated the efficacy and safety of zanidatamab in previously treated patients with unresectable, locally advanced, or metastatic HER2-positive BTC. Zanidatamab demonstrated clinically meaningful anticancer activity and durable responses in subjects with previously treated HER2-positive BTC. As of October 10, 2022, the objective response rate (ORR), median duration of response (DOR), and median progression-free survival (PFS) assessed by independent central review (ICR) were 41.3% (95% CI: 30.4–52.8), 12.9 months (95% CI: 6.0–not estimable), and 5.5 months (95% CI: 3.7–7.2), respectively. “Acceptance of this BLA in China represents a significant milestone in the global effort to bring effective, targeted treat...