Zymeworks' BLA For Zanidatamab For HER2-positive BTC Accepted By CDE In China

(RTTNews) - Monday, Zymeworks Inc. (ZYME) announced that the National Medical Products Administration's Center for Drug Evaluation or CDE in China has accepted the Biologics License Application or BLA for Zanidatamab for the second-line treatment of HER2-positive biliary tract cancer, also known as BTC.

The company confirmed that the BLA is backed by data from the HERIZON-BTC-01 clinical trial.

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