Chinese acceptance of zanidatamab filing
The Center for Drug Evaluations of the National Medical Products Administration (NMPA) in China has accepted the biologics license application (BLA) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (BTC).
This is good news for Zymeworks (Nasdaq: ZYME), a Canadian biotech that develops protein therapeutics for the treatment of cancer as well as for autoimmune and inflammatory diseases. Shares in the company were more than 2% higher early in Tuesday morning's trading in New York.
Zanidatamab is a bispecific antibody developed using Zymeworks’ proprietary Azymetric platform that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. It is being advanced in multiple cancer types in partnership with US biopharma Jazz Pharmaceuticals (Nasdaq: JAZZ) and Sino-American biotech BeiGene (Nasdaq: BGNE).
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