Suzhou Siran Biotechnology Co. Ltd. (SiranBio) has entered a worldwide exclusive license agreement with GSK (excluding mainland China, Hong Kong, Macau and Taiwan) for SA030, a potential first-in-disease, long-acting, small interfering RNA (siRNA) oligonucleotide in development for treatment of metabolic and vascular disease.

GSK will pay an upfront fee as well as potential future success-based development, regulatory and  commercial milestones payments up to $1.005 billion, and tiered royalties on global product net sales (excluding mainland China, Hong Kong, Macau and Taiwan). SiranBio will lead the clinical development of SA030 through the completion of phase I, following which GSK will assume responsibility for development, regulatory filings, and commercialization outside of mainland China, Hong Kong, Macau and Taiwan.

About SiranBio’s Oligonucleotide Candidate

SA030 has recently entered phase I trials and targets activin receptor-like kinase 7 (ALK7), an established therapeutic mechanism for cardiometabolic disease. The program represents broad clinical and market potential given unaddressed cardiometabolic risk across multiple chronic diseases.

According to SiranBio, Targeting ALK7 could reduce abdominal fat (visceral adipose tissue, VAT) while preserving lean mass, leading to improved insulin sensitivity, blood lipid profile and reduced fat cell-driven inflammation. They claim that growing evidence links VAT to cardiometabolic risk and lowering this in people with chronic inflammatory diseases could have a greater impact on their survival than managing the underlying disease alone.

Preclinical studies have shown a differentiated, long-acting profile for SA030 that could address the underlying inflammation associated with cardiometabolic risk through adipocyte (fat cell)-directed delivery and a low-frequency dosing schedule. SA030 has a complementary and distinct mechanism to GLP- 1 agonists and SGLT2 inhibitors, supporting potential future combination approaches to lower remaining cardiometabolic risk not fully addressed by current therapies.

SA030 will benefit from GSK’s extensive expertise in oligonucleotide therapeutics, such as siRNA and antisense oligonucleotides (ASO), a key modality that could address therapeutic targets, including ALK7, that are not amenable to traditional small molecules or biologics.

Zhiwei Yang, Founder & CEO, SiranBio, said: “We are very honored to be recognized by a top biopharma company for our cutting-edge extrahepatic delivery technology and siRNA pipeline. GSK’s resources and clinical development capabilities have the potential to accelerate the transformation of our innovative pipeline into therapeutics, benefitting more people in the reduction of fat and related chronic diseases.”