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SCYNEXIS Announces Hansoh Pharma’s Application to National Medical Products Administration (NMPA) in China for Phase 3 Trial of Ibrexafungerp for Treatment of Vulvovaginal Candidiasis (VVC)
Submission is part of the Hansoh Pharma licensing agreement and strategic partnership to research, develop and commercialize ibrexafungerp in the Greater
About this update from Scynexis, Inc.
[{"type":"text","content":"Submission is part of the Hansoh Pharma licensing agreement and strategic partnership to research, develop and commercialize ibrexafungerp in the Greater China region\nJERSEY CITY, N.J., Sept. 13, 2021 (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 Hansoh Pharmaceutical Group Company Limited (Hansoh Pharma) has filed an investigational new drug (IND) application with the National Medical Products Administration (NMPA) of the People’s Republic of China for a Phase 3 study evaluating the efficacy and safety of ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Earlier this year, SCYNEXIS signed an exclusive licensing agreement and strategic partnership with Hansoh Pharma, one of the leading biopharmaceutical companies in China, to research, develop and commercialize ibrexafungerp in the Greater China region. Ibrexafungerp, the first and only new class of antifungal drug approved by the U.S. Food and Drug Administration (FDA) in more than 20 years, received U.S. regulatory authorization in June. “This clinical trial application is a critical first step as Hansoh works to develop and bring this groundbreaking antifungal treatment to potentially millions of patients in China,” said Marco Taglietti, M.D., President and CEO of SCYNEXIS. “We believe Hansoh Pharma has exactly the right capabilities and expertise to successfully develop and commercialize ibrexafungerp in China, and we are thrilled to see the team achieve this important milestone.” About Ibrexafungerp Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is in late-stage development for multiple indications, including life-threatening fungal infections caused primarily by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has demonstrated broad-spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, in...