[October 21, 2025, Suzhou, China] Suzhou Siran Biotechnology announces SA1211 was approved for Phase I clinical trial in China (Approval Number: 2025LP02762), for the treatment of chronic hepatitis B (CHB).  SA1211 is the first dual-targeting siRNA drug which silences mRNA of HBV and PD-L1 on the infected hepatocytes.  It is also the first single molecule dual-targeting siRNA that got IND approval in the world.

CHB is a major challenge of public health in the world.  The goal for new CHB therapeutics is the functional cure, i.e., to eliminate HBV DNA and HBsAg in serum without viral relapse.  Although tremendous progresses have been made for the HBV viral clearance, high percentage of viral rebound is the major challenge for the first-line drugs as well as the most promising new drugs in clinical trials.  To address that, SiranBio invented two siRNA molecules: the first one degrades HBV mRNA, and the second one silences the PD-L1 mRNA in hepatocytes.  We further connected those two molecules into a dimer based on our proprietary dual-targeting platform technology, and achieved a single molecule that has the pharmacodynamics of combo treatment: eliminates HBV and restores acquired immune response.  In pre-clinical studies, >80% of mice were functional cured with single injection of SA1211.  Those results were orally presented in AASLD, and was acclaimed widely.

The IND approval of SA1211 may provide a novel approach for the functional cure of CHB.  SA1211 is expected to provide a novel therapeutic approach for the functional cure of chronic hepatitis B. The dual-targeting siRNA platform technology can be applied in many other chronic diseases which involve the modulation of multiple targets simultaneously.  SiranBio is working on several dual-target as well as extrahepatic delivered siRNA drugs and pushing them to clinical stages. In CMC studies, SiranBio and Hongene Bioengineering worked together to overcome huge challenges in the process chemistry and analytical method development for dual-targeting siRNA, laying a solid foundation to support SA1211 and future dual-targeting siRNAs into clinical trials and commercialization.

About SiranBio

SiranBio was founded in Biobay of Suzhou in May 2022.  We are a Biotech company focusing on siRNA drug discovery.  Our core team is composed of top scientists and industrial experts with many years of experiences in the related fields. We have received several awards including Suzhou Industrial Park Leading Enterprise and Gusu Leading Enterprise. 

We have independently developed cutting-edge and proprietary platform technologies that covers the full spectrum of nucleic acid drug discovery, including eSAFE chemical modification, the Stork-W dual-targeting platform, and intra- and extrahepatic delivery technologies.  We developed drug pipelines for viral infections, cardiovascular and metabolic diseases, and have set up multiple licensing and collaborations with renowned domestic and international pharmaceutical companies. Committed to patient-centered innovation, SiranBio strives to innovate best siRNA drugs for unmet clinical needs and better health for mankind.