CSPC Innovation Pharmaceutical (300765.SZ) subsidiary Juishi Biologics' therapeutic vaccine SYS6026 received the drug clinical trial approval notification.

CSPC Innovation Pharmaceutical (300765.SZ) announced that its subsidiary CSPC PHARMA Giant Stone Biopharmaceutical Co., Ltd. (referred to as "Giant Stone Biopharmaceutical") recently received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration for the therapeutic vaccine SYS6026 targeting precancerous lesions caused by human papillomavirus (HPV). Clinical trials will be conducted in the near future. According to the Drug Administration Law of the People's Republic of China and relevant regulations, after review, SYS6026 injection solution, which was accepted on August 16, 2024, meets the requirements for drug registration and is approved to conduct clinical trials for patients with high-grade squamous intraepithelial lesions (HSIL) related to HPV 16/18. It is reported that SYS6026 is the first therapeutic vaccine developed independently based on the company's mRNA platform, consisting of messenger RNA (mRNA) molecules combined with lipid nanoparticle (LNP) delivery systems. This product expresses the HPV16 or 18 type E6 and E7 antigens through mRNA, inducing the body to generate a specific T cell immune response, thereby eliminating HPV-infected cells and blocking the process of carcinogenesis.