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Hansoh Pharma Announces Application for Phase 3 Trial of Ibrexafungerp for the Treatment of Vulvovaginal Candidiasis (VVC)

2021.09.13 Size

Shanghai, China — September 13, 2021— Hansoh Pharma (HKEX 3692.HK), an innovative biopharmaceutical company, carrying the mission of "create excellence in pharmaceuticals, enhance innovation in China", which has been committed to improving human health through continuous innovation, especially in major disease treatment fields including oncology, CNS, anti-infectives, diabetes and autoimmune disease, announced today that the company 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).

Ibrexafungerp, the first fourth-generation antifungal drug with a new mechanism of action discovered and developed in more than 20 years, was approved by the U.S. Food and Drug Administration (FDA) in June 2021. The therapy is being studied and developed by U.S.-based SCYNEXIS, Inc. (NASDAQ:SCYX) as a broad-spectrum, systemic antifungal for multiple severe fungal infections in community and hospital settings. Under a licensing agreement with SCYNEXIS announced in February 2021, Hansoh will be responsible for the development, regulatory approval, and commercialization of ibrexafungerp in Greater China.


Aifeng Lyu, Ph.D., President of Hansoh Pharma, said, “Antifungal resistance is on the rise, posing a global health threat, and with only three classes of antifungal drugs on the market in China, we recognize the urgent need for more effective antifungal therapies. We believe in ibrexafungerp’s potential to address this need, and we are confident that with our integrated R&D, manufacturing, and commercial infrastructure, we can make ibrexafungerp a significant commercial success in Greater China. We look forward to initiating and progressing this Phase 3 trial to bring this differentiated antifungal to patients in Greater China.”


About Ibrexafungerp

Ibrexafungerp 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, including azole- and echinocandin-resistant strains.


SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME® (ibrexafungerp tablets), which was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

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About Hansoh Pharma

Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in Asia, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 10,000 dedicated employees in China and the United States.

Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions across a broad range of therapeutic areas, including oncology, central nervous system (CNS) disorders, infectious diseases, diabetes, and autoimmune diseases. With the support of over 1,600 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including almonertinib (阿美乐®), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations, flumatinib (昕福®), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML), PEG-loxenatide (孚来美®), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes, morinidazole (迈灵达®), a third-generation nitroimidazole antibiotic and tenofovir amibufenamide (恒沐®), the first second-generation oral anti-HBV drug developed in China.

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