Core Insights - The FDA has expanded the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C), removing the previous requirement for a cardiovascular disease diagnosis [1][2] - Repatha is recognized as an effective therapy for lowering LDL-C, especially for patients who are statin-resistant or intolerant [2] - Repatha has been used by over 5 million people globally since its initial approval in 2015 [2] Company Overview - Amgen is a biotechnology company that focuses on discovering, developing, manufacturing, and delivering innovative medicines for serious diseases [10] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [11] Product Information - Repatha is a human monoclonal antibody that inhibits PCSK9, leading to increased LDL receptors and reduced LDL-C levels [3] - The clinical safety and efficacy of Repatha have been validated through 15 years of research involving over 57,000 patients across 50 clinical trials [3] Regulatory Status - Repatha is approved in over 74 countries, including the U.S., Japan, Canada, and all EU member states, with additional applications pending in other regions [4] Safety and Efficacy - Common adverse reactions reported in clinical trials include nasopharyngitis, upper respiratory tract infections, and injection site reactions, with hypersensitivity reactions occurring in 5.1% of patients treated with Repatha [9][14] - The most common adverse reactions in the cardiovascular outcomes trial included diabetes mellitus and upper respiratory tract infections [9]

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].