Zymeworks Gets China's NMPA Approval For Zanidatamab

(RTTNews) - Zymeworks Inc. (ZYME), a clinical-stage biotechnology company, Friday said that the National Medical Products Administration (NMPA) in China has approved zanidatamab for the treatment of HER2-high expression (IHC3+) biliary tract cancer (BTC).

Zymeworks' 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, Zymeworks said in a statement.

In connection with the NMPA approval of zanidatamab, Zymeworks is entitled to receive $20 million in milestone payment. Zymeworks is eligible to receive up to $144 million in additional development and commercial milestones. It will also get tiered royalties of up to 19.5% of sales in BeOne Medicines territories.

Zanidatamab was approved by the U.S. Food and Drug Administration (FDA) in November 2024 for the treatment of BTC. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of zanidatamab for treating BTC.