FX.co ★ Zymeworks' BLA For Zanidatamab For HER2-positive BTC Accepted By CDE In China

On Monday, Zymeworks Inc. (ZYME) announced that China's National Medical Products Administration's Center for Drug Evaluation (CDE) has accepted the Biologics License Application (BLA) for Zanidatamab. This application pertains to the second-line treatment of HER2-positive biliary tract cancer (BTC).

The company indicated that the BLA submission is supported by data from the HERIZON-BTC-01 clinical trial.

Furthermore, under the terms of Zymeworks' licensing and collaboration agreement with BeiGene, Ltd. for the development and commercialization of Zanidatamab in the Asia Pacific region, Zymeworks is set to receive an $8 million milestone payment. Additionally, the company could earn up to $164 million in further milestone payments and royalties based on product sales in the region.