BeyondSpring (NASDAQ: BYSI) has announced an exclusive co-development and commercialization agreement with Jiangsu Hengrui Pharmaceuticals Co. Ltd in Greater China for BeyondSpring’s experimental drug product plinabulin as a first-in-class selective immunomodulation Microtubule-bonding agent (SIMBA.
Plinabulin under FDA review
The U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) are now reviewing plinabulin in conjunction with G-CSF for the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has revealed positive topline Phase 3 findings from its DUBLIN-3 study of plinabulin in combination with docetaxel to treat EGFR wild-type non-small cell lung cancer in patients in their second and third lines (NSCLC). Outside of Greater China, BeyondSpring will maintain 100 percent of the global plinabulin rights.
BeyondSpring CEO Dr. Lan Huang said, “We are thrilled to continue executing on our global commercialization plans by entering into this partnership with Hengrui, a world-class leader in pharmaceuticals with substantial expertise in oncology research and development and deep experience in marketing in China. This landmark partnership serves as a validation from a well-respected, leading pharma for plinabulin as a ‘pipeline in a drug. Over the past 40 years, Hengrui has successfully grown to become the largest oncology drug sales company in China, with the top-selling PD-1 inhibitor and docetaxel product, and one of the top three G-CSF products in China”.
BeyondSpring releases
Jiangsu Hengrui, President of Global R&D, Lianshan Zhang, said, “The U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) are now reviewing plinabulin in conjunction with G-CSF for the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has revealed positive topline Phase 3 findings from its DUBLIN-3 study of plinabulin in combination with docetaxel for the treatment of EGFR wild-type non-small cell lung cancer in patients in their second and third lines (NSCLC). Outside of Greater China, BeyondSpring will maintain 100 percent of the global plinabulin rights.”
