- Zymeworks (ZYME, Financial) receives NMPA approval in China for zanidatamab, a first-of-its-kind bispecific antibody for HER2+ biliary tract cancer.
- The approval triggers a $20 million payment from BeOne Medicines, with potential additional milestones totaling $144 million.
- Zanidatamab has already secured FDA approval and received a positive CHMP opinion in Europe.
Zymeworks Inc. (Nasdaq: ZYME) has announced that the National Medical Products Administration (NMPA) in China has granted conditional approval for zanidatamab. This approval makes it the first dual HER2-targeted bispecific antibody available for the treatment of HER2-positive biliary tract cancer (BTC) in China. The approval is part of an ongoing partnership with BeOne Medicines Ltd., which will result in a $20 million milestone payment to Zymeworks.
The conditional approval is a significant milestone, addressing the high unmet medical needs of patients with HER2-positive BTC, a rare and aggressive form of cancer. Although the approval is conditional and requires further confirmation through ongoing clinical trials, it opens up avenues for additional revenue through potential development and commercial milestones worth up to $144 million. Zymeworks is also set to receive tiered royalties up to 19.5% based on sales in BeOne's covered territories.
Previously, zanidatamab received FDA approval in the United States in November 2024 for treating adults with unresectable or metastatic HER2-positive BTC. Furthermore, the Committee for Medicinal Products for Human Use (CHMP) in Europe issued a positive opinion in April 2025, suggesting a likely approval in the European Union soon.
This development highlights Zymeworks' growing influence in the oncology field, underlining its capacity to deliver innovative treatments for difficult-to-treat cancers. The company's global regulatory progress suggests zanidatamab could have a strong commercial impact in major markets, further validating Zymeworks' proprietary bispecific antibody technology.
