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)
SCYNEXIS has announced that its partner, Hansoh Pharma, has filed an IND application for a Phase 3 study of ibrexafungerp in China, targeting vulvovaginal candidiasis. This follows an exclusive licensing agreement between the companies to develop and commercialize ibrexafungerp in the region. Ibrexafungerp is the first new antifungal drug approved by the FDA in over two decades, emphasizing its potential in combating drug-resistant infections. The collaboration aims to leverage Hansoh's capabilities to enhance treatment accessibility for patients in China.
- IND application filed in China for Phase 3 study of ibrexafungerp.
- Exclusive licensing agreement with Hansoh Pharma to develop and commercialize ibrexafungerp in Greater China.
- Ibrexafungerp is the first new class of antifungal drug approved by the FDA in over 20 years.
- Collaboration expected to improve treatment access for millions of patients in China.
- Potential regulatory hurdles in obtaining approval for commercial launch in China.
- SCYNEXIS's reliance on third parties for commercialization efforts could pose risks.
Submission is part of the Hansoh Pharma licensing agreement and strategic partnership to research, develop and commercialize ibrexafungerp in the Greater China region
JERSEY 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, including azole- and echinocandin-resistant strains.
About SCYNEXIS
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. For more information, visit www.scynexis.com.
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.
For more information, visit www.hspharm.com.
Forward Looking Statements
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding the commercial launch of ibrexafungerp, the potential benefits of ibrexafungerp, and this collaboration for the commercialization of ibrexafungerp in China. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks inherent in ability by SCYNEXIS or Hansoh to successfully obtain regulatory approval to commence the commercial launch of ibrexafungerp in China; SCYNEXIS’s need for additional capital resources; and SCYNEXIS's reliance on third parties to conduct SCYNEXIS's commercialization efforts. These and other risks are described more fully in SCYNEXIS's filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Form 10-Q under the caption "Risk Factors" and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
SCYNEXIS
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
Media Relations
Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
ggasaatura@lifescicomms.com
Hansoh Pharma
Investor Relations
Dr. Sophia Dong
IR@hspharm.com
FAQ
What is the purpose of the IND application filed by Hansoh Pharma for SCYX?
What is ibrexafungerp's significance in the antifungal drug market?
How does the partnership with Hansoh Pharma benefit SCYNEXIS?
What potential risks does SCYNEXIS face regarding its IND application?
