regulatory
confidence high
sentiment positive
materiality 0.65
NMPA accepts zanidatamab BLA in China; Zymeworks earns $8M milestone from BeiGene
Zymeworks Inc.
- China's NMPA accepted BLA for zanidatamab in second-line HER2+ biliary tract cancer.
- Acceptance triggers $8 million milestone payment from partner BeiGene under Asia Pacific license.
- FDA previously granted priority review for same indication; PDUFA target date Nov 29, 2024.
- Zanidatamab is also being developed by Jazz Pharmaceuticals in the U.S.
- Milestone payment expected to be received following NMPA acceptance.