CSPC Pharmaceutical Group Limited ‘s chemical 1-class new drug, a double-stranded small interfering RNA drug, has received approval for clinical trials from the FDA
November 25, 2025
Source: drugdu
78
On November 24th, CSPC (01093) released an announcement stating that the group's independently developed chemical Class 1 new drug, the double-stranded small interfering RNA drug (SYH2061 injection), has been approved by the US Food and Drug Administration (FDA) and can now conduct clinical trials in the United States. Additionally, this product was approved by the China National Medical Products Administration in October 2025 to conduct clinical trials in China.
SYH2061 injection is a siRNA drug that achieves liver-targeted delivery through the conjugation of acetylated galactosamine (GalNAc). It aims to target the complement protein C5 (C5) and effectively reduce its level. Preclinical studies have shown that this product outperforms other similar siRNA products in terms of drug activity and drug efficacy persistence, and has high clinical development value. It is suitable for the treatment of IgA nephropathy and other complement-mediated related diseases.
https://finance.eastmoney.com/a/202511243573136076.html
By editor
Copyright©2025 Ddu. All rights reserved.
Read more on
- Multiple batches of quadrivalent influenza virus split vaccine have been sub-packaged and submitted for lot release approval; expected to be released to the market soon after approval December 12, 2025
- Ab&B Bio-Tech CO., LTD. JS Lyophilized Human Rabies Vaccine Initiates Phase III Clinical Trials December 12, 2025
- The ‘Sweetest’ HPV Vaccine Market is Gone | Haibin Interview December 12, 2025
- InnoCare Pharma announced that its first independently developed next-generation TRK inhibitor, zoletrazinib, has been approved for marketing in China December 12, 2025
- Is PD-1/VEGF dual antibody + ADC becoming the standard configuration? December 12, 2025
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
