Research & Development
Scynexis, Hansoh Pharma Inks Licensing Deal for Ibrexafungerp in Greater China
18 February 2021 - - US-based biotechnology company Scynexis, Inc. (NASDAQ: SCYX) and China-based biopharmaceutical company Hansoh Pharmaceutical Group Company Ltd. (3692: HK) have forged a strategic partnership and license agreement for the development and commercialization of Ibrexafungerp for the Greater China region, the companies said.

Ibrexafungerp is a first-in-class, broad-spectrum triterpenoid antifungal agent providing the therapeutic advantages of both intravenous and oral formulations.

It is currently under review by the US Food and Drug Administration for the treatment of vaginal yeast infections, and in late-stage development for multiple indications, including life-threatening fungal infections in hospitalized patients.

Under the terms of the agreement, Hansoh shall be responsible for the development, regulatory approval, and commercialization of ibrexafungerp in Greater China.

Scynexis will receive a USD 10m upfront payment and will also be eligible to receive development and commercial milestones, plus low double-digit royalties on net product sales.

Ibrexafungerp is an oral antifungal product candidate under regulatory review for the treatment of vaginal yeast infection also known as vulvovaginal candidiasis.

Its mechanism of action is fungicidal against Candida species, meaning it kills fungal cells. In December 2020, the US Food and Drug Administration accepted a New Drug Application for ibrexafungerp and granted a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021.

The NDA is supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated statistically superior efficacy and a favorable tolerability profile in women with VVC.

If approved, this could be the first new antifungal class in over 20 years, and the first and only non-azole treatment for vaginal yeast infections.

Scynexis' lead candidate ibrexafungerp (formerly known as SCY-078), a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, is under regulatory review for vaginal yeast infection and in late-stage development for multiple life-threatening fungal infections in hospitalized patients.

Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in Asia, has more than 10,000 dedicated employees in China and the United States.