Zymeworks' Cancer Drug Application Accepted by China’s NMPA

Published 21 hours agoZYME

Zymeworks' Cancer Drug Application Accepted by China’s NMPA

Zymeworks Inc. has achieved a major regulatory milestone with the National Medical Products Administration (NMPA) in China accepting its Biologics License Application (BLA) for zanidatamab. This development is crucial as it brings Zymeworks' targeted treatment for HER2-positive biliary tract cancer (BTC) a step closer to patients in China, expanding global access to potentially life-saving therapies.

The NMPA's acceptance of the BLA is backed by conclusive data from the HERIZON-BTC-01 clinical trial. This trial indicated that zanidatamab achieved an objective response rate of 41.3%, with patients displaying a median duration of response lasting 12.9 months. These statistics highlight zanidatamab's effectiveness for patients with previously treated, unresectable, locally advanced, or metastatic HER2-positive BTC.

Adding to the successful application acceptance, Zymeworks stands to gain financially through its partnership with BeiGene. According to Reuters, the company is set to receive an $8 million milestone payment following the NMPA's decision, with opportunities for additional milestones and royalties up to $164 million as the drug progresses in the Asia Pacific market. Meanwhile, Zymeworks continues to see international advancements, with the U.S. FDA having granted accelerated approval to zanidatamab in late 2024, marketed as Ziihera, further underscoring its global therapeutic potential.

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