Zymeworks: China NMPA accepts BLA for zanidatamab

Zymeworks (ZYME) announced that the Center for Drug Evaluation of the National Medical Products Administration in China has accepted the BLA for zanidatamab for second-line treatment of HER2-positive BTC. Under the terms of Zymeworks’ Asia Pacific license and collaboration agreement with BeiGene (BGNE) for the development and commercialization of zanidatamab, Zymeworks is entitled to receive an $8M milestone payment. Zymeworks also remains eligible to receive up to $164M based on additional milestones plus royalties on product sales in the Asia Pacific region. Under the terms of its collaboration with BeiGene regarding zanidatamab, Zymeworks has received $53M in upfront and milestone payments as well as certain co-development funding for zanidatamab clinical studies, not including the $8M milestone payment Zymeworks is eligible to receive in connection with the NMPA’s acceptance of the BLA for zanidatamab for second-line treatment of HER2-positive BTC. Through our collaboration with BeiGene on zanidatamab, we remain eligible to receive up to $164M in additional development and commercial milestones together with tiered royalties of up to 19.5% of net sales in BeiGene territories.