Shanghai Junshi Biosciences Co., Ltd. announce that recently, the Company has received the Acceptance Notice issued by the National Medical Products Administration. Two supplemental new drug applications for the Company's
product Ongericimab injection have been accepted. Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody independently developed by the Company. The Company is the first domestic company in China to obtain clinical trial approval for drug targeting to PCSK9. The Company completed two Phase III clinical studies in patients with primary hypercholesterolemia (including familial and non-familial heterozygous) and mixed hyperlipidemia, a Phase II clinical study in patients with homozygous familial hypercholesterolemia, and a Phase III clinical study in patients with heterozygous hypercholesterolemia. In addition, a Phase III clinical study of monotherapy in patients with primary hypercholesterolemia and mixed hyperlipidemia (statin intolerance and intermediate to low cardiovascular risk) finished the primary analysis. In April 2023, the new drug application for ongericimab was accepted by the National Medical Products Administration for the treatment of: (1) primary hypercholesterolemia (including familial and non-familial heterozygous) and mixed dyslipidemia; and (2) homozygous familial hypercholesterolemia in adults or adolescents aged 12 or above. According to the Chinese Guidelines for Lipid Management (2023), cardiovascular disease is the leading cause of death among urban and rural residents in China, with a predominant focus on atherosclerotic cardiovascular disease ("ASCVD"). The rise of low-density lipoprotein cholesterol ("LDL-C") level is a dangerous factor in causing an ASCVD. Reducing the level of LDL-C can
significantly lower the incidence of ASCVD and the risk of death. Despite statins currently being the cornerstone of lipid lowering treatment, approximately 9.1% of patients clinically exhibit statin intolerance, with a higher proportion observed in Asian populations. Discontinuation of statins or the use of only tolerable doses in patients with statin intolerance may lead to suboptimal LDL-C levels, potentially hindering the achievement of reducing the patient's ASCVD risk. The supplemental new drug applications are mainly based on two registered clinical trials (JS002-005 and JS002-007). JS002-005 (NCT05325203) is a randomized, double-blind, placebo-controlled Phase III clinical studies completed for the adult patients of HeFH. JS002-007 (NCT05621070) is a randomized, double-blind, placebo-controlled Phase III clinical studies completed for the adult patients of primary hypercholesterolemia and mixed hyperlipidemia in which statins are not tolerated or contraindicated.