Mycovia Pharma Announces Partner Jiangsu Hengrui Pharma

Mycovia Pharmaceuticals Inc Announces Partner Jiangsu Hengrui Pharmaceuticals Co Ltd Commercial Launch of VIVJOA® (Oteseconazole) Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VVC) in China

Mycovia Pharmaceuticals Inc an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui") has commercially launched VIVJOA® (oteseconazole) in China, making available an innovative oral azole antifungal indicated for the treatment of severe vulvovaginal candidiasis (VVC). VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.

The availability of VIVJOA for the treatment of severe VVC in China is an important achievement of Mycovia's 5-year partnership with Hengrui. The 2-day oral regimen, recently approved by the National Medical Products Administration, was previously shown in a randomized phase 3 study to have superior efficacy to the current standard-of-care, fluconazole, in women presenting with severe VVC.

"We celebrate our partner, Hengrui, on bringing VIVJOA to the Chinese market, the second largest pharmaceutical market in the world," said Patrick Jordan, CEO of Mycovia and Managing Partner at NovaQuest Capital Management. "The disease burden in China is significant, and access to VIVJOA provides health care providers and women suffering with severe VVC a new treatment option."

Vulvovaginal candidiasis is an exceedingly common mucosal infection usually caused by Candida albicans but can occasionally be caused by other Candida species or yeasts. Typical symptoms include vulvovaginal itching, irritation, burning, soreness, fissuring, redness, vaginal discharge, and dyspareunia. Approximately 70% to 75% of women in all strata of the society will experience at least one episode during their lifetime.

Oteseconazole is designed to selectively inhibit fungal CYP51, which is required for fungal cell wall integrity. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared to fungal CYP enzymes.

In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) Capsules as the first medication for Recurrent Vulvovaginal Candidiasis (RVVC, or chronic yeast infection). VIVJOA is currently available in the U.S. at over 300 Walgreens Community Specialty Pharmacies.

About Recurrent Vulvovaginal Candidiasis

RVVC is a debilitating, chronic infectious condition that affects 138 million women worldwide each year. RVVC, also known as chronic yeast infection, is a distinct condition from vulvovaginal candidiasis (VVC) and defined by the Centers for Disease Control and Prevention as three or more symptomatic acute episodes of yeast infection in 12 months. Primary symptoms include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain.

About VIVJOA®

VIVJOA® (oteseconazole) is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. VIVJOA is the first FDA-approved medication that provides sustained efficacy demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus comparators.

Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this selective interaction is also toxic to fungi, resulting in the inhibition of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared to fungal CYP enzymes. The FDA approved VIVJOA based upon the positive results from three phase 3 clinical trials of oteseconazole – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including 875 patients at 232 sites across 11 countries.

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