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.