By Fineline Cube 
China’s Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that it has received two additional indication approvals from the National Medical Products Administration (NMPA) for its Junshida (ongericimab). The anti-PCSK9 monoclonal antibody is now approved for use in adult patients with heterozygous familial hypercholesterolemia (HeFH) and for use alone or in combination with ezetimibe in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or for whom statins are contraindicated. The approval covers two formulations: 150 mg/1 mL per prefilled syringe and 150 mg/1 mL per prefilled auto-injector.
Clinical Trial Results
The NMPA’s decision was based on results from two regulatory studies, JS002-005 and JS002-007. In the JS002-005 study, a randomized, double-blind, placebo-controlled Phase III clinical trial in adult patients with HeFH, ongericimab demonstrated significant reductions in LDL-C levels by 69.4% and 80.6% (p<0.0001) over 24 weeks of treatment. The drug also improved multiple lipid parameters and maintained a good safety profile.
Prior Approval
Ongericimab was previously approved in China in October 2024 for the treatment of adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia. This latest approval further expands the therapeutic applications of Junshida, making it the first domestically developed PCSK9-targeted therapy approved in China for statin-intolerant populations.-Fineline Info & Tech