Zymeworks (ZYME) announced that the National Medical Products Administration in China has approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer. The conditional approval marks the first and only1 dual HER2-targeted bispecific antibody approved for HER2-high expression BTC in China. Zymeworks’ collaboration partner, BeOne Medicines Ltd., 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.
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