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BeyondSpring Initiates New Drug Application Rolling Submission for Plinabulin in China for Chemotherapy-Induced Neutropenia
- Potential to be First Superior Therapy to Standard of Care for Chemotherapy-Induced Neutropenia in 30 Years - - Targeting CIN After All Chemotherapies in
About this update from Beyondspring, Inc.
[{"type":"text","content":"- Potential to be First Superior Therapy to Standard of Care for Chemotherapy-Induced Neutropenia in 30 Years -\n - Targeting CIN After All Chemotherapies in All Cancer Types in Combination with All G-CSFs - - Strong Patent Protection Through 2036 - NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company headquartered in New York focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has initiated the rolling submission of its New Drug Application (NDA) with the Company’s lead asset, Plinabulin, for the chemotherapy-induced neutropenia indication to China’s National Medical Products Administration (NMPA). “Commencing the NDA rolling submission in China marks a significant milestone for BeyondSpring, bringing Plinabulin one step closer to commercialization to enhance the lives of cancer patients,” said Dr. Lan Huang, BeyondSpring’s co-founder and CEO. “Our clinical results clearly demonstrate that there is a significant need for improvement in the prevention of CIN. CIN is a common side effect of chemotherapy and can have a devastating impact on cancer care. Plinabulin has the potential to not only reduce infections and other clinical consequences associated with CIN, but also help patients to maintain their optimal chemotherapy care, which potentially prolongs their lives.” If approved, Plinabulin in combination with G-CSFs can potentially be the first superior therapy to the standard of care (G-CSF alone) for chemotherapy-induced neutropenia in 30 years, with a broad label for the prevention of CIN after all chemotherapies in all cancer types in combination with all G-CSFs. The Company expects to submit an NDA for the same indication to the U.S. Food and Drug Administration (FDA) in the second half of 2020. About Plinabulin in CIN StudiesStudy 105 and Study 106 trials are both multicenter, double blind Phase 3 trials to support Plinabulin’s broad application in preventing CIN to be used with all chemotherapy and for all cancers. Study 105 was designed to evaluate the safety and efficacy in NSCLC, breast cancer, and prostate cancer patients with risk factors, treated with docetaxel (Day 1 dose) in a 21-day cycle with a single dose of Plinabulin (40 mg, Day 1 dose) vs. a single dose of N...