Chinese acceptance of zanidatamab filing

11 June 2024

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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