Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its self-developed chemical class 1 new drug, SYH2061 injection, which is set to enter clinical trials in the United States. The drug has also been approved by the National Medical Products Administration of China for clinical trials starting in October 2025 [1]. Group 1 - The drug is a siRNA medication that utilizes GalNAc for targeted delivery to the liver, aiming to reduce complement protein C5 levels effectively [1]. - SYH2061 is the first domestically developed ultra-long-acting siRNA drug targeting C5 to enter clinical trials, indicating significant progress in the treatment of IgA nephropathy and other complement-mediated diseases [1]. - Preclinical studies demonstrate that SYH2061 outperforms similar siRNA products in terms of drug activity and efficacy duration, showcasing its long-lasting effects, good safety profile, and high patient compliance [1].
石药集团(01093)：双链小干扰RNA药物(SYH2061注射液)在美国获临床试验批准