Hansoh Pharma's New Oral Antifungal Drug Ibrexafungerp Approved in China for Vulvovaginal Candidiasis

Apr 08, 2025 15:51 CST Updated 15:51

Hansoh Pharma

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Today (April 8), the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that Hansoh PharmaDeclaredIbrexafungerp Citrate TabletsThe new drug marketing application has been approved.According to an earlier press release from Hansoh Pharma, Ibrexafungerp is an antifungal drug with a novel mechanism of action, and this approval is for use in...Treatment of Vulvovaginal Candidiasis (VVC) in Adult and Postmenarchal Females。

Screenshot source: NMPA official website

VVC is a common and frequently occurring disease among women of childbearing age, with approximately 75% of women experiencing it once in their lifetime, and 40%-50% experiencing recurrence. The clinical manifestations of the disease include vulvar itching and increased vaginal discharge.Burning pain、Dysuria, dyspareunia, etc. VVC recurs and is difficult to cure, seriously affecting the patient's quality of life.

Ibrexafungerp（ibrexafungerp，HS-10366）Is aA novel triterpenoid structure glycogen synthase inhibitor, is an antifungal drug with a novel mechanism of action.In vitro and in vivo tests have shown that this product has broad-spectrum antifungal activity and can be used forAzoles and EchinocandinsInfections caused by multidrug-resistant strains. In addition, this productWith oral andConvenient to use with two injectable formulations, which is expected during hospitalizationAnd OutpatientWidely used in the environment.

Ibrexafungerp InitiallyDeveloped by SCYNEXIS. In February 2021, Hansoh Pharma entered into a licensing agreement with SCYNEXIS, responsible forIbrexafungerpDevelopment, Regulatory Approval and Commercialization in China. Currently,IbrexafungerpApproved by the US FDA for two indications, respectively used forTreatment of Vulvovaginal Candidiasis (VVC)AndReduce the Incidence of Recurrent Vulvovaginal Candidiasis (RVVC)。

According to the earlier press release from Hansoh Pharma, the current submission for marketing approval of Ibrexafungerp Citrate Tablets in China is based on a...Multicenter, Randomized, Double-blind, Placebo-controlledPhase 3 clinical trial, the trialInChinese Adult Patients with Vulvovaginal CandidiasisThe efficacy and safety of HS-10366 were evaluated in China. The trial met the pre-specified superiority criteria in the primary and key secondary endpoints, demonstrating a statistically significant advantage over placebo.

Ibrexafungerp Receives FDA Approval for the Treatment of VCC Based onPositive results from two Phase 3 clinical studies show that once-daily oral administration of the drug demonstrated significant efficacy and good tolerability in patients with VVC.After 10 days of treatment, 63.3% of patients reached the primary endpoint of "clinical cure.", 58.5% of patients achieved the secondary endpoint of mycological eradication, and 72.3% of patients showed clinical improvement.

References:

[1]Drug Approval Certificate Delivery Information on April 8, 2025. Fromhttps://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250408154249119.html

[2]SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections. Retrieved June 2, 2021, from https://www.globenewswire.com/news-release/2021/06/02/2240294/0/en/SCYNEXIS-Announces-FDA-Approval-of-BREXAFEMME-ibrexafungerp-tablets-as-the-First-and-Only-Oral-Non-Azole-Treatment-for-Vaginal-Yeast-Infections.html

[3] Hansoh Pharma's New Antifungal Drug Ibrexafungerp Citrate Tablets Accepted for Marketing Application. Retrieved July 20, 2023, from https://mp.weixin.qq.com/s/NAFiqx_EW3p4bZoHUxGd-A

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