ApolloBio Corp., a joint stock company of China’s leading cephalosporin manufacturer Shandong Jincheng Pharmaceutical and Chemical Co., Ltd (SHE: 300233), has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for VGX-3100. This drug, hailed as the world’s first therapeutic vaccine for human papillomavirus (HPV), is co-developed with U.S. firm Inovio Pharmaceuticals, Inc. The upcoming clinical trial will focus on assessing the efficacy of VGX-3100 in treating HPV-16/18 related anal precancerous lesions, following previous clearance for studies on cervical intraepithelial neoplasia (CIN).
In 2018, ApolloBio secured an exclusive licensing agreement with Inovio, granting it the manufacturing and marketing rights for VGX-3100 in China, including Hong Kong, Macau, and Taiwan. Phase III clinical study data from China, where the study was conducted in a blinded manner, indicated that VGX-3100 demonstrated good safety and tolerance profiles within the Chinese population. Notably, the response rate in some patient subgroups reached as high as 70%, highlighting the potential impact of this therapeutic vaccine in addressing HPV-related conditions.- Flcube.com
