Disclaimer: Due to limited expertise, errors are inevitable, and some information may not be the most up-to-date. Comments pointing out any issues are welcome. This article is only an introduction to medical and health-related drugs and does not recommend any treatment plans (if involved). This article does not constitute any investment advice.
On October 7, the CDE website showed that the Class 1 new drug SGB-3403 Injection, independently developed by SANEGENEBIO, obtained tacit approval for clinical trial application (acceptance number: CXHL2300741) for the treatment of hypercholesterolemia.
SGB-3403 is an RNAi drug targeting PCSK9 and also the first innovative RNAi drug developed by SANEGENEBIO.The first dosing in healthy subjects was completed in Australia at the end of May this year, and the single-dose escalation trial is also proceeding steadily. SGB-3403 is a siRNA-GalNAc conjugate targeting PCSK9 in hepatocytes. It utilizes SANEGENEBIO's proprietary next-generation GalNAc conjugation delivery technology and can be used clinically for the treatment of hypercholesterolemia, mixed dyslipidemia, and atherosclerotic cardiovascular diseases to reduce the risk of cardiovascular events.SANEGENEBIOBiologyIt also showed stronger activity and longer-lasting efficacy compared to the对标product in preclinical disease models, making it a promising "Best-In-Class" siRNA drug for this target.SANEGENEBIO, established in early 2021, is a biopharmaceutical company dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology, with research and development centers in both China and the United States. The founding team consists of senior experts in the field of nucleic acid drugs, possessing years of experience in nucleic acid drug development and cutting-edge technical expertise in the industry. To date, the company has successfully built a globally leading platform for nucleic acid drug chemical modification and intrahepatic and extrahepatic delivery technologies with independent intellectual property rights, accelerating the research and development process of RNAi drugs with differentiated advantages. Its first core product has entered clinical trials, while multiple pipeline products are also under parallel development, covering disease areas such as cardiovascular and cerebrovascular and metabolic diseases, immune-mediated diseases, and neurological disorders.
References:SANEGENEBIO
