Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer
Shots:
- The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025
- Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTC
- Approval triggers a $20M milestone under Zymeworks & BeOne Medicines’ APAC license & collaboration deal, under which Zymeworks has received $61M to date & is eligible for ~$144M in additional development & commercial milestones, plus tiered royalties up to 19.5% of net sales
Ref: Globenewswire| Image: Zymeworks| Press Release
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