GeneScience Pharmaceuticals gets NMPA acceptance for GenSci142 capsules trial

Changchun High & New Technology Industry Group announced that its subsidiary, Changchun GeneScience Pharmaceuticals Co., Ltd. (GeneScience Pharmaceuticals), has received acceptance from the National Medical Products Administration (NMPA) for the clinical trial application of GenSci142 capsules for domestic production and drug registration. The application is for the treatment of bacterial vaginosis.

GenSci142 capsules represent a recombinant lysin developed by GeneScience Pharmaceuticals, specifically targeting Gardnerella bacteria. The drug aims to directly destroy bacterial cell walls, leading to rapid lysis and death. It offers advantages over traditional treatments, including rapid onset, precise bactericidal action, efficient biofilm clearance, low resistance risk, and localized safety. Bacterial vaginosis is a common vaginal infection in women of childbearing age, characterized by a decrease in hydrogen peroxide-producing lactobacilli and an overgrowth of anaerobic bacteria, particularly Gardnerella.

The company stated that a successful clinical trial would expand its business structure, optimize its product portfolio, and enhance its core competitiveness. However, it also cautioned investors about the inherent risks associated with pharmaceutical R&D, including the long development cycles and potential uncertainties in the clinical trial process. The company committed to timely disclosure of future progress.