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SCYNEXIS and Hansoh Pharma Announce NMPA Acceptance of the New Drug Application for Ibrexafungerp in China
JERSEY CITY, N.J., July 20, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and
About this update from Scynexis, Inc.
[{"type":"text","content":"JERSEY CITY, N.J., July 20, 2023 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that China’s National Medical Products Administration (NMPA) has accepted for review a New Drug Application (NDA) for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) in the Chinese mainland. The application was submitted by partner Hansoh Pharmaceutical Group Company Limited (3692.HK), one of the leading biopharmaceutical companies in China, and is based on positive results from Phase 3 studies in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints. In February 2021, SCYNEXIS entered into an agreement for the development and commercialization rights for oral ibrexafungerp in the greater China region with Hansoh Pharma. Under the terms of the agreement, Hansoh is responsible for the development, regulatory approval and commercialization of ibrexafungerp in Greater China. Ibrexafungerp, once approved, is expected to become a new, first in class anti-fungal treatment for Chinese patients with vulvovaginal candidiasis (VVC). “We are delighted by the progress of our partner and the opportunity to make our novel antifungal agent available to patients worldwide,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We are excited to be contributing to the global fight in the treatment of fungal infections.” Ms. Sun Yuan, Executive Director of the Board of Hansoh Pharma, added, “The successful NDA filing of Ibrexafungerp in China marks a significant step in our efforts to combat antifungal resistance, a pressing global health threat. We appreciate the exceptional work carried out by our team and strong support from our partner throughout the regular filing process and the initial assessment conducted by the NMPA. The acceptance of the NDA brings us one more step closer to making this novel and differentiated antifungal available to patients in Greater China.” About IbrexafungerpIbrexafungerp is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpen...