On June 2, Synexis, a partner of Jiangsu Hansoh Pharmaceutical Group Co., Ltd. ("Hansoh Pharma" or the "Company"), announced that the innovative antifungal drug BREXAFEMME (ibrexafungerp) was approved by the U.S. Food and Drug Administration (FDA) as scheduled, becoming the world's first and only oral non-azole drug approved for vaginal yeast infection.
BREXAFEMME (ibrexafungerp) is the first approved fourth-generation antifungal drug with a new mechanism of action in more than 20 years. Unlike the fungus-inhibiting mechanism of action of azoles, BREXAFEMME (ibrexafungerp) can kill fungal cells, and its approval for marketing represents a major breakthrough in antifungal infection in the field of women's health. Candida vaginal infection is the first indication for FDA approval of BREXAFEMME (ibrexafungerp), as a new one-day oral therapy.
Approximately 70-75% of women worldwide experience vaginal yeast infection at least once in their lifetime, and no innovative therapy has been available in this field since 1990. Clinical manifestations of vaginal yeast infection include itching and burning pain in vulva, which seriously affect the quality of life. At present, the common therapy is local application or oral administration of azole antifungal drugs, but the clinical application is limited and the antifungal drug resistance continues to rise. Therefore, patients need safer and more effective innovative antifungal therapies, and there is an urgent medical need in clinical practice. Up to now, azoles are the only class of drugs approved in the U.S. for the treatment of vaginal yeast infection.
As early as February this year, Hansoh Pharma has signed an exclusive license and cooperation agreement with Synexis and obtained the exclusive right to develop and commercialize ibrexafungerp in Greater China. Hansoh Pharma is currently actively advancing ibrexafungerp in pivotal registrational clinical trials in China and in the development of multiple potential indications.
As a leading innovation-driven pharmaceutical company in China, Hansoh Pharma has a global perspective and insists on the combination of "bringing in" and "going out" to make diversified exploration of unmet medical needs in clinical practice and innovate international cooperation. Previously, the Company has reached strategic cooperation with EQRx, Viela Bio, Terns Pharmaceuticals, NiKang Therapeutics, and Atomwise to integrate advantageous resources through license-in/out for the benefit of patients worldwide.
Hansoh Pharma will continue to uphold the corporate mission to "create excellence in pharmaceuticals, enhance innovation in China", drive development with innovation, and keep developing more innovative drugs, promoting the innovation and upgrade of national pharmaceutical competitiveness, and improving human health and quality of life.
