On June 10, 2024, Zymeworks Inc. announced that the Center for Drug Evaluations of the National Medical Products Administration in China has accepted the biologics license application for zanidatamab for second-line treatment of HER2-positive biliary tract cancer. Under the terms of the Company?s Asia Pacific license and collaboration agreement with BeiGene Ltd. for the development and commercialization of zanidatamab, the Company is entitled to receive an $8 million milestone payment upon acceptance of the BLA by the NMPA. The NMPA acceptance follows the announcement in May 2024 by the Company?s partner Jazz Pharmaceuticals plc regarding the U.S. Food and Drug Administration?s acceptance and grant of priority review of the BLA for zanidatamab for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive BTC.

Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 29, 2024.