China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) filing for its ibrexafungerp, intended for the treatment of vulvovaginal candidiasis (VVC) in adult and post-menarche females.
Phase III Study Results and NDA Filing
The filing is supported by the results of a multi-center, randomized, double-blind, placebo-controlled Phase III study that assessed the efficacy and safety of ibrexafungerp in VVC adult patients in China. The study successfully met pre-set superiority standards in terms of primary and secondary endpoints, demonstrating the drug’s potential effectiveness and safety profile.
Ibrexafungerp: A Novel Antifungal Drug with a Unique Mechanism
Ibrexafungerp is the world’s first novel triterpenoid structure glycogen synthase inhibitor and an antifungal drug with a unique mechanism of action. In vivo and in vitro experiments have shown that it possesses broad-spectrum antifungal activity, making it effective against various drug-resistant strains, including those resistant to azoles and echinocandins. This innovative approach to antifungal treatment offers a new option for patients suffering from VVC.
Partnership with SCYNEXIS, Inc. for Greater China Rights
Hansoh Pharma secured a licensing deal with the US originator SCYNEXIS, Inc. (NASDAQ: SCYX) in February 2021, obtaining development, regulatory filing, and commercialization rights to ibrexafungerp in Greater China. This partnership underscores Hansoh Pharmaceutical’s commitment to bringing innovative treatments to the region and expanding access to advanced medical solutions for patients in need.-Fineline Info & Tech
