Hansoh Pharma Submits Phase III Clinical Trial Application to NMPA for Global First-in-Class Antifungal Ibrexafungerp

On September 13, Hansoh Pharma (Hansoh Pharmaceutical, 3692.HK) announced that the company has submitted a Phase III clinical trial application to China's National Medical Products Administration (NMPA) for ibrexafungerp, for which it holds Greater China rights, for the treatment of vulvovaginal candidiasis (VVC).

On February 11 this year, Hansoh Pharma announced that it had entered into an exclusive license and collaboration agreement with SCYNEXIS, Inc. (NASDAQ: SCYX). Under the licensing agreement, Hansoh Pharma, as the licensee, will obtain exclusive rights from SCYNEXIS to research, develop, and commercialize ibrexafungerp in China, Hong Kong, Macao, and Taiwan. In consideration for the exclusive rights, the licensee agreed to pay SCYNEXIS a $10 million upfront payment, plus potential milestone payments and royalties.

Ibrexafungerp is a globally first-in-class, fourth-generation novel triterpenoid antifungal agent with a completely novel mechanism of action. It exhibits broad-spectrum antifungal activity and offers the therapeutic advantages of both intravenous and oral formulations. As a novel glucan synthase inhibitor, ibrexafungerp combines the potent activity of this drug class with the potential flexibility of oral and intravenous administration, positioning it for widespread use in both inpatient and outpatient settings.

On June 2 this year, ibrexafungerp (brand name: BREXAFEMME) received approval from the U.S. Food and Drug Administration (FDA), becoming the world's first and only approved oral non-azole antifungal for vaginal yeast infections.

Previously, the U.S. FDA granted Brexafemme Qualified Infectious Disease Product (QIDP) designation, Fast Track designation, and Orphan Drug designation. Brexafemme is expected to receive ten years of market exclusivity in the United States, including five years of New Chemical Entity (NCE) exclusivity and an additional five years of exclusivity due to the QIDP designation. Brexafemme is also protected by multiple patents, including a composition of matter patent covering the ibrexafungerp molecule. With patent term extension, this patent is expected to expire in 2035, providing 14 years of protection in the United States.

Globally, approximately 70%–75% of women experience at least one episode of vaginal yeast infection in their lifetime, with no innovative therapies introduced in this field since 1990. Clinically, vaginal yeast infection manifests as vulvar pruritus and burning pain, severely compromising quality of life. Current mainstream treatments consist of topical or oral azole antifungal agents; however, their clinical application is limited, and antifungal drug resistance continues to rise. Consequently, there is an urgent unmet clinical need for safer and more effective innovative antifungal therapies.

Ibrexafungerp can be developed into dosage forms such as oral and injectable preparations, facilitating convenient administration. Multiple indications are already in late-stage clinical development, including nosocomial infections caused by fungi such as *Candida* (including *Candida auris*) and *Aspergillus* species. *In vivo* and *in vitro* studies have demonstrated that ibrexafungerp exhibits broad-spectrum antifungal activity and can be used to treat infections caused by strains resistant to multiple drug classes, including azoles and echinocandins.