Zymeworks’ zanidatamab approved in China
Canadian clinical-stage biotech Zymeworks (Nasdaq: ZYME) today announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab (trade name Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC).
The company noted that the conditional approval marks the first and only dual HER2-targeted bispecific antibody approved for HER2-high expression (IHC3+) BTC in China. Zymeworks’ collaboration partner, BeOne Medicines (Nasdaq: ONC), formerly BeiGene, obtained the conditional approval under the terms of its Asia Pacific license and collaboration agreement with Zymeworks. Continued approval of this indication will depend on the verification of clinical benefit in the patient population through ongoing confirmatory trials.
The biologics license application (BLA) for zanidatamab was submitted to the NMPA in June last year.
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