Zymeworks Receives Conditional NMPA Approval for HER2+ Biliary Tract Cancer in China

Zymeworks has received conditional approval from China's National Medical Products Administration (NMPA) for zanidatamab, a dual HER2-targeted bispecific antibody for treating previously treated, unresectable, or metastatic HER2-positive biliary tract cancer (BTC). This marks the first approval of such a therapy in China, with the continuation of approval dependent on ongoing confirmatory clinical trials. The approval triggers a $20 million milestone payment from BeOne Medicines, Zymeworks' collaboration partner in the region, with potential additional milestones up to $144 million and tiered royalties of up to 19.5% on net sales. Zanidatamab had previously received FDA approval in the U.S. and a positive opinion from the European CHMP, highlighting its growing global regulatory footprint. Despite current financial challenges and mixed sentiment around Zymeworks stock, analysts generally maintain an 'Outperform' rating with price targets suggesting significant upside potential. This approval underscores Zymeworks' commitment to advancing innovative treatments for difficult-to-treat cancers and expanding its presence in major markets.