Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biopharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for JS401, an injectable co-developed with Risen Pharma, for the treatment of hyperlipidemia.
JS401’s Mechanism of Action
JS401 is an innovative angiopoietin-like 3 (ANGPTL3) mRNA-targeted small interfering RNA (siRNA) product. It is designed to treat hyperlipidemia by specifically degrading the ANGPTL3 mRNA in hepatocytes, thereby continuously inhibiting the expression of the ANGPTL3 protein. ANGPTL3, expressed by the liver, plays a crucial role in lipid metabolism by inhibiting lipoprotein lipase (LPL) and endothelial lipase (EL). The loss or inhibition of ANGPTL3 function can significantly reduce triglyceride levels and other atherogenic lipoproteins, making JS401 a promising therapy for lowering blood lipids, including triglycerides and cholesterol.
Market Context and Competitive Landscape
Currently, only Evkeeza (evinacumab-dgnb), an ANGPTL3-targeted monoclonal antibody (mAb) developed by Regeneron, is commercially available for treating patients with homozygous familial hypercholesterolemia (HoFH) in children or adults aged 12 years and above. There is no siRNA product with the same target approved for marketing, making JS401 a potentially groundbreaking therapy in the hyperlipidemia treatment landscape.
Conclusion
The NMPA’s approval of the clinical trial for JS401 is a significant milestone for Junshi Biosciences and its partner Risen Pharma. As a novel siRNA therapy, JS401 has the potential to offer a new treatment option for patients with hyperlipidemia, addressing a significant unmet medical need and contributing to the advancement of lipid-lowering therapies.-Fineline Info & Tech
