Suzhou Siran Biotechnology Co.,Ltd. announced that its independently developed siRNA drug SA030 Injection, targeting ALK7 (Activin Receptor-Like Kinase 7), has officially received ethical approval from the Australian Human Research Ethics Committee (HREC) to proceed with a Phase I clinical trial in Australia. This marks the official entry of SA030 into the clinical development stage, representing a significant milestone in SiranBio's innovative drug research and development in the field of metabolic diseases.

SA030 Injection is a first-in-class candidate drug developed by SiranBio based on its independently developed STORK-F adipose delivery platform, targeting individuals who are overweight or obese. The approved clinical study is a randomized, double-blind, placebo-controlled Phase I trial (Protocol No: SAOB101-AUS) designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SA030 in overweight or obese participants.

Obesity has become a global public health challenge, and SA030 Injection, with its unique mechanism of action, aims to provide a safer and effective treatment option for overweight or obese individuals. The successful ethical approval of SA030 by the Australian HREC (application submitted on January 28, approved on February 24) serves as a strong acknowledgment and recognition of SiranBio's R&D capabilities and product quality. We will rapidly advance the Phase I clinical trial and look forward to bringing new treatment hope to obese participants worldwide at an early date.

About STORK-F Delivery Platform

The STORK-F adipose delivery platform is a core component of SiranBio’s non-liver tissue delivery technology portfolio. Developed through iterative technical innovation and leveraging the Company’s comprehensive expertise in nucleic acid drug delivery, STORK-F features high specificity and efficiency tailored to the unique characteristics of adipose tissue. Preclinical data from non-human primate (NHP) studies across multiple targets, including ALK7, have validated its efficacy and safety. Additionally, the platform is fully compatible with SiranBio’s proprietary dual-target siRNA technology, enabling precise modulation and potentiation of adipose tissue-specific therapeutic pathways.

About SiranBio

Founded in May 2022 in Suzhou Industrial Park, SiranBio is a biotechnology company dedicated to the development of innovative siRNA drugs. Co-founded by a team of top scientists and industrialization experts in the nucleic acid therapy field, the company has been recognized as a Suzhou Industrial Park Leading Enterprise and Gusu Leading Enterprise.

SiranBio has established an industry-leading nucleic acid drug technology platform with independent intellectual property rights, including eSAFE chemical modification technology, the Stork-W dual-target platform, and intrahepatic/extrahepatic delivery platform technologies. Based on these advanced platforms, the company has built a pipeline of nucleic acid drugs targeting antiviral, cardiovascular, and metabolic diseases, and has entered into multiple out-licensing and R&D cooperation agreements with renowned domestic and international pharmaceutical companies.