Mycovia Pharmaceuticals, an emerging biopharmaceutical company, announced that Jiangsu Hengrui Pharmaceuticals (Hengrui) received approval in June from the National Medical Products Administration (NMPA) for Oteseconazole Capsules, an azole antifungal, indicated for the treatment of severe vulvovaginal candidiasis (VVC).

Oteseconazole Capsules is contraindicated for females of reproductive potential, pregnant and lactating women, patients with known hypersensitivity to active ingredients, excipients and azoles.

The approval of Oteseconazole Capsules for the treatment of severe VVC in China is an important milestone under Mycovia's exclusive agreement with Hengrui to develop and commercialize oteseconazole in China, including Mainland China, Hong Kong, Macau and Taiwan, for the treatment or prevention of a range of fungal conditions.

The approval of Oteseconazole Capsules was based on a Phase 3 study with 322 patients at 27 sites. The primary study endpoint was the proportion of subjects with therapeutic cure (defined as the absence of symptoms and signs of VVC with negative fungal culture candidiasis) at Day 28.

"We celebrate and congratulate our partner, Hengrui, on receiving its approval for Oteseconazole Capsules for the treatment of severe VVC," said Patrick Jordan, CEO of Mycovia and Managing Partner at NovaQuest Capital Management. "The disease burden in China is significant and the approval of Oteseconazole Capsules gives another treatment option for those women suffering with VVC."

In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) Capsules, as the first medication for Recurrent Vulvovaginal Candidiasis (chronic yeast infection).