Junshi Biosciences Receives NMPA Approval for Ongericimab’s Supplemental New Drug Applications in China
Wednesday, May 28, 2025
Shanghai Junshi Biosciences has announced that the National Medical Products Administration (NMPA) has approved two supplemental new drug applications (sNDAs) for its ongericimab injection.
Cardiovascular disease remains the leading cause of death in China’s urban and rural populations, with atherosclerotic cardiovascular disease (ASCVD) being the main subtype. Elevated low-density lipoprotein cholesterol (LDL-C) is a key risk factor for ASCVD. Effective lowering of LDL-C can reduce the incidence and mortality associated with this condition.
HeFH, a common form of familial hypercholesterolemia affecting approximately 1 in 200 to 1 in 250 people, is characterised by significantly elevated LDL-C and early coronary artery disease. Failure to reach LDL-C targets with treatments such as statins puts these patients at high cardiovascular risk.
Ongericimab is a recombinant humanised anti-PCSK9 monoclonal antibody independently developed by Junshi Biosciences. It is available in 150 mg pre-filled syringes and pre-filled auto syringes.
The approvals cover treatment for: 1) adults with heterozygous familial hypercholesterolemia (HeFH); and 2) adults with non-familial hypercholesterolemia or mixed dyslipidemia who are statin-intolerant or have contraindications to statins, either as monotherapy or in combination with ezetimibe.
JS002-005, a randomised, double-blind, placebo-controlled phase 3 study, involved 135 adult patients with HeFH. It was the first phase 3 trial of an anti-PCSK9 monoclonal antibody in Chinese HeFH patients. Results published in Atherosclerosis showed ongericimab significantly reduced LDL-C by 69.4% with 150 mg every two weeks and 80.6% with 450 mg every four weeks over 24 weeks, with sustained effects. Other lipid markers, including non-HDL cholesterol, apolipoprotein B, total cholesterol, and lipoprotein (a) levels, also decreased notably, with Lp(a) reducing by 50%. The safety profile was comparable to placebo.
JS002-007, also a randomised, double-blind, placebo-controlled phase 3 study, evaluated ongericimab in adult patients with primary hypercholesterolemia or mixed dyslipidemia who were statin-intolerant.
Source: globenewswire.com
