Suzhou SiranBio Co., Ltd. (Siranbio) announced today that its independently developed small interfering RNA (siRNA) therapeutic candidate SA030, targeting activin receptor-like kinase 7 (ALK7), submitted a pre-IND consultation to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China on January 21, 2026. Subsequently, the Company filed an Investigational New Drug (IND) application with the Therapeutic Goods Administration (TGA) of Australia and submitted the clinical trial application to the Human Research Ethics Committee (HREC) on January 28, 2026. It also plans to submit a pre-IND meeting request to the U.S. Food and Drug Administration (FDA) in February 2026.

As a member of the transforming growth factor-β (TGF-β) superfamily, ALK7 plays a pivotal role in regulating energy metabolism and adipose tissue homeostasis. SA030 utilizes Siranbio’s proprietary STORK-F adipose tissue-targeted delivery platform to specifically silence ALK7 gene expression in adipose tissues, thereby promoting lipolysis and improving systemic metabolic profiles. This approach holds great promise as a novel therapeutic option for patients with suboptimal responses, intolerance, or post-treatment weight regain to existing GLP-1 receptor agonist (GLP-1RA) therapies.

The planned clinical studies will evaluate the safety, tolerability, and preliminary clinical pharmacodynamics of SA030 both as monotherapy and in combination with GLP-1RAs in overweight or obese subjects. The combination regimen is expected to exert synergistic effects, facilitating healthy fat reduction while preserving muscle mass, thus advancing innovative obesity treatment paradigms.

As one of the global first-in-class ALK7-targeted siRNA therapies entering clinical development, the simultaneous regulatory engagement and clinical filings across China, Australia, and the United States highlight Siranbio’s global development strategy and unwavering confidence in the clinical value and market potential of SA030. Following regulatory clearance, the Company plans to initiate the first-in-human (FIH) clinical trial of SA030 in Australia in the second quarter of 2026, representing a critical milestone in validating this innovative therapeutic modality.

About STORK-F Delivery Platform

The STORK-F adipose tissue-targeted 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.