Zymeworks Inc. announced on May 30, 2025, that the National Medical Products Administration (NMPA) in China has granted conditional approval for zanidatamab. This approval is for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC) with high expression (IHC3+).
This milestone marks zanidatamab as the first and only dual HER2-targeted bispecific antibody approved for HER2-high expression BTC in China. The conditional approval was obtained by Zymeworks’ collaboration partner, BeOne Medicines Ltd., under the terms of its Asia Pacific license and collaboration agreement.
In connection with this NMPA approval, Zymeworks is entitled to receive a $20 million milestone payment from BeOne Medicines. The company is also eligible for up to $144 million in additional development and commercial milestones, along with tiered royalties of up to 19.5% of net sales in BeOne Medicine’s territories, significantly enhancing Zymeworks' revenue potential.
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