Dezhan Health JV's new indication cleared for clinical trials

Dezhan Health's (SZSE:000813) joint venture, Beijing Orient Gene Biotech, has received approval from China's National Medical Products Administration (NMPA) to conduct clinical trials for a new indication of the VGX-3100 project. The project, a collaboration with Inovio Pharmaceuticals, targets HPV-16/18 related vaginal intraepithelial neoplasia (VIN) II. VGX-3100, already in Phase III trials for cervical precancerous lesions and Phase II for anal precancerous lesions, is poised to become the first domestic treatment for VIN II to enter Phase II clinical trials. The company highlights that VGX-3100 has the potential to clear HPV16/18 viruses and restore affected tissues, addressing a significant unmet medical need. While the approval marks progress, Dezhan Health cautions about the uncertainties inherent in drug development, including clinical trial outcomes and regulatory approvals.