Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for adult patients with primary hypercholesterolemia and mixed dyslipidemia, who are unable to achieve their low-density lipoprotein cholesterol (LDL-C) targets despite moderate or higher doses of statin therapy.
The approval comes on the heels of two pivotal Phase III studies, JS002-003 and JS002-006, which were multi-center, randomized, double-blinded, and placebo-controlled. The JS002-003 study demonstrated that ongericimab significantly reduced LDL-C levels by over 60% compared to placebo and maintained this reduction throughout the 52-week treatment period. Furthermore, it showed significant improvements in other blood lipid parameters, including non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), and total cholesterol (TC).
The JS002-006 study further confirmed the drug’s efficacy by showing a significant reduction in LDL-C levels by over 70% after just 12 weeks of treatment. Ongericimab also exhibited a favorable safety profile in both studies, positioning it as a promising addition to the treatment armamentarium for patients with uncontrolled hypercholesterolemia.- Flcube.com
