Zymeworks Announces China NMPA Acceptance of Biologics License Application for Zanidatamab for Second-Line Treatment of Biliary Tract Cancer
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.