Hansoh Pharma's First-in-Class Broad-Spectrum Antifungal Ibrexafungerp Approved in China for Vulvovaginal Candidiasis

Apr 08, 2025 15:57 CST Updated 15:57

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

On April 8, the NMPA website showed that Hansoh Pharma submitted Ibrexafungerp.(Ibrexafungerp Tablets; R&D Code: HS-10366)Approved for marketing, for adult and post-menarche femalesVulvovaginal Candidiasis（VVC）Treatment.

Screenshot source: NMPA official website

The approval and market launch of Ibrexafungerp in China is based on a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial.（CTR20220918）The positive results. This study aims toEvaluation of the Efficacy and Safety of HS-10366 in Chinese Adult Patients with Vulvovaginal Candidiasis.The primary endpoint of the study isAt the TOC visit, the mITT population achieved clinical cure.(Complete resolution of symptoms and signs)Proportion of Subjects。

In 2024, the research findings were published in "Infection》Magazine.The research results show that,IbrexafungerpDemonstrated good efficacy and safety in the treatment of VVC in Chinese patients.

Compared with placebo,AcceptIbrexafungerpClinical cure rate of treated patients at TOC（51.0% vs. 25.6%）Fungal eradication rate（55.6% vs. 18.2%）, Overall Response Rate（33.9% vs. 8.3%）Complete remission rate of symptoms at follow-up（74.5% vs. 39.7%）Significantly higher.

IbrexafungerpIs aThe world's first fourth-generation novel triterpenoid antifungal agent with a completely new mechanism of action,Only one day of oral medication required。In vivo and in vitro tests have shownIbrexafungerpHasBroad-spectrum antifungal activity, which can be used for infections caused by drug-resistant strains of various drugs such as azoles and echinocandins.

IbrexafungerpDeveloped by U.S.-based SCYNEXIS, in February 2021, Hansoh Pharma entered into a licensing agreement with SCYNEXIS to assume responsibility for the drug in China.(Including Hong Kong, Macao and Taiwan)Development, regulatory approval, and commercialization.

Currently,IbrexafungerpApproved by the FDA for two indications, respectively, for the treatment ofVulvovaginal Candidiasis（VVC）AndReduce the Incidence of Recurrent Vulvovaginal Candidiasis（RVVC）. The drug isFirst ApprovedOral antifungal drugs used to treat VVC and reduce the incidence of RVVC.

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