Zymeworks' zanidatamab wins NMPA conditional approval in China for HER2+ BTC; $20M milestone due

Zymeworks Inc.

NMPA (China) conditionally approved zanidatamab for previously treated unresectable/metastatic HER2+ biliary tract cancer (IHC3+).
Zymeworks receives $20M milestone from BeOne Medicines (formerly BeiGene); already received $61M in prior payments.
Eligible for up to $144M in additional development/commercial milestones and tiered royalties up to 19.5% on net sales.
Approval based on HERIZON-BTC-01 study showing overall survival benefit; confirmatory trials ongoing.
Zanidatamab previously approved by FDA (Nov 2024); EMA CHMP positive opinion (Apr 2025) for same indication.

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