Hansen Pharmaceutical's introduction of "first-in-class" antifungal drug was approved for Phase 3 clinical trials in China

ArticleMedicine Guanlan

According to the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (CDE) and public information, Scinexis's oral antibacterial drug ibrexafungerp tablet has obtained the implied license of the clinical trial, and will start the treatment of vulvovaginal candidiasis (VVC) in China.

Screenshot source: CDE official website

Ibrexafungerp (SCY-078) is a new type of glucan synthase inhibitor, which combines the good activity of glucan synthase inhibitor with the potential flexibility of oral and intravenous administration.

In February 2021, Hansen Pharmaceuticals signed a licensing agreement with Scinexis.

In the United States, the FDA has granted ibrexafungerp Qualified Infectious Disease Product Designation (QIDP), Fast Track Designation, and Orphan Drug Designation

▲Introduction of ibrexafungerp (picture source: Scynexis official website)

The approval of the drug in the United States is based on the positive results of two phase 3 clinical studies.

Vulvovaginal candidiasis (also known as vaginal yeast infection) is the second most common vaginal infection in women.

At present, there are few antifungal drugs approved for marketing in China, and there are urgent unmet clinical needs in this field

references:

[1] Center for Drug Evaluation of China National Medical Products Administration.

[3] Hansen Pharmaceuticals announced that Ibrexafungerp was used for the treatment of acute mycotic vaginitis indication and submitted a Phase III clinical trial application.

[4] "IBREXAFUNGERP Tablets" received clinical trial approval notice.