JERSEY CITY, NJ – SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company that is pioneering innovative drugs to overcome and prevent difficult-to-treat and drug-resistant infections, announced that Hansoh Pharmaceutical Group Company Limited (Hansoh Pharma) has submitted an application for a new investigational medicinal product (IND) to the National Administration for Medical Devices (NMPA) by People’s Republic of China for a phase 3 study to evaluate the effectiveness and safety of ibrexafungerp for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.
Earlier this year SCYNEXIS signed an exclusive license agreement and strategic partnership with Hansoh Pharma, one of the leading biopharmaceutical companies in Chinato research, develop and commercialize Ibrexafungerp in the US Greater China Region. Ibrexafungerp, the first and only new class of antifungal drugs made by the US Food and Drug Administration (FDA) received in more than 20 years US regulatory approval in June.
‘This clinical trial application is an important first step as Hansoh works to develop this breakthrough antifungal treatment and potentially millions of patients in China,’ called Marco Taglietti, MD, President and CEO of SCYNEXIS. ‘We believe Hansoh Pharma has just the right skills and expertise to successfully develop and commercialize Ibrexafungerp China, and we are very pleased that the team is reaching this important milestone. ‘
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an antifungal agent and the first representative of a new class of structurally different glucan synthase inhibitors, the triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of oral and intravenous (IV) formulations. Ibrexafungerp is in late development for several indications, including life-threatening fungal infections mainly caused by Candida (including C. auris) and Aspergillus species in hospitalized patients. It has shown a broad spectrum of antifungal activity in vitro and in vivo against multi-drug resistant pathogens, including azole and echinocandin resistant strains.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative drugs to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming more and more resistant. SCYNEXIS Scientists are developing the company’s lead product, Ibrexafungerp (formerly known as SCY-078), as a broad spectrum systemic antifungal agent for multiple fungal indications in both the community and hospitals. SCYNEXIS has launched its first commercial product in the US, BREXAFEMME (ibrexafungerp tablets), which is sold by the US Food and Drug Administration (FDA) June 1, 2021. In addition, the late-stage clinical trial of Ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. More information is available at www.scynexis.com.
Above Hansoh Pharma
Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in Asia, strives to discover and develop life-changing drugs to help patients overcome serious illnesses and disorders. Hansoh Pharma is supported by over 10,000 dedicated employees in. supports China and The United States.
Founded in 1995, Hansoh has fully integrated research and development, manufacturing and trading capabilities and supports leadership positions in a variety of therapeutic areas including oncology, central nervous system (CNS) diseases, infectious diseases, diabetes and autoimmune diseases. With the support of over 1,600 highly qualified R&D experts, Hansoh has successfully developed several internally discovered drug candidates into NMPA-approved innovative drugs, including almonertinib (???), a third generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations, flumatinib (??), a second generation BCR-ABL inhibitor for the first-line treatment of chronic myeloid leukemia (CML), PEG-loxenatide (???), the first once-weekly long-acting GLP-1 analog used in. was discovered and developed China used to treat diabetes, morinidazole (???), a third-generation nitroimidazole antibiotic, and tenofovir-amibufenamide (??), the first second-generation oral anti-HBV drug used in China.
Further information can be found at www.hspharm.com.
The 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 to commercialize Ibrexafungerp in China. Because such statements are subject to risks and uncertainties, actual results could differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to: Risks inherent in the ability to operate SCYNEXIS or Hansoh to successfully obtain regulatory approval to commence commercial launch of ibrexafungerp in. to start China; SCYNEXIS’s Need for additional capital resources; and SCYNEXIS’s Trust in the behavior of third parties SCYNEXIS’s Commercialization efforts. These and other risks are described in more detail in SCYNEXIS’s Submissions with the Securities and Exchange Commission, including, but not limited to, the latest Annual Report on Form 10-K and Form 10-Q under the heading “Risk Factors” and other documents to be submitted later at the. submitted or submitted to her Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date of their publication. SCYNEXIS assumes no obligation to update such statements to reflect events or circumstances that occur after the date of their publication.
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DR. Sophia Dong
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