Zymeworks Inc., a clinical-stage biotechnology company, has announced that China's National Medical Products Administration (NMPA) has granted conditional approval for zanidatamab. This marks the first and only dual HER2-targeted bispecific antibody approved for the treatment of previously treated, unresectable or metastatic HER2-positive biliary tract cancer $(BTC.AU)$ in China. The approval was obtained under Zymeworks' collaboration with BeOne Medicines Ltd., which entitles Zymeworks to a $20 million milestone payment from BeOne Medicines. Additionally, Zymeworks remains eligible to receive up to $144 million in further development and commercial milestones, alongside tiered royalties of up to 19.5% of net sales in BeOne Medicine's territories. The continued approval of zanidatamab is dependent on the verification of clinical benefit through ongoing confirmatory trials.
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