GenSci142 capsules for bacterial vaginosis gets clinical trial approval for GeneScience

Changchun High & New Technology Industry Group announced its subsidiary, Changchun GeneScience Pharmaceutical Co., Ltd., has received National Medical Products Administration approval for the clinical trial of GenSci142 capsules for domestic production and drug registration. The application was approved for the treatment of bacterial vaginosis (BV).

GenSci142 capsules are a Class 1 innovative biological product developed by GeneScience Pharmaceutical Co., Ltd. The approval represents the first new drug clinical trial application approved under the National Medical Products Administration's "30-day fast-track," designed to optimize innovative drug clinical trial review and approval processes. BV is a common vaginal infection in women of childbearing age with significant unmet clinical needs, often resistant to existing treatments.

This development is expected to broaden the company's business structure, optimize its product portfolio, and enhance its core competitiveness. However, the company also noted that pharmaceutical product development is characterized by high technology, high risk, and high added value, with lengthy and multi-stage processes from research to market, subject to uncertainties. Investors are advised to exercise caution due to inherent investment risks.