Junshi Biosciences Announces Ongericimab’s sNDA Approval in China

Core Viewpoint - Junshi Biosciences has received approval from the National Medical Products Administration (NMPA) for two supplemental new drug applications for ongericimab, marking it as China's first domestic PCSK9-targeted drug approved for statin-intolerant patients [1][10]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [13]. - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [13]. - Junshi Biosciences has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [13]. Product Details - Ongericimab is a recombinant humanized anti-PCSK9 monoclonal antibody injection, approved for three indications in China: 1) adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia; 2) adult patients with heterozygous familial hypercholesterolemia (HeFH); 3) statin-intolerant patients with non-familial hypercholesterolemia and mixed dyslipidemia [11]. - The approved specifications for ongericimab are 150 mg (1 ml) in a single dose, available in pre-filled syringes and autosyringes [11]. Clinical Trials - The approval of ongericimab is based on two registered clinical trials: JS002-005 and JS002-007 [6]. - JS002-005 involved 135 patients with HeFH and demonstrated significant LDL-C reductions of 69.4% and 80.6% compared to placebo [8]. - JS002-007 is focused on statin-intolerant patients with primary hypercholesterolemia and mixed dyslipidemia, with results to be published soon [9]. Market Context - Cardiovascular disease is the leading cause of death in China, with atherosclerotic cardiovascular disease (ASCVD) being the predominant subtype [2]. - Lowering LDL-C levels is crucial for reducing the incidence of ASCVD and associated mortality [2]. - Approximately 9.1% of patients exhibit statin intolerance, which is more prevalent in Asian populations, leading to suboptimal LDL-C levels and increased cardiovascular risk [4].