Core Viewpoint - The approval of LEROCHOLTM (lerodalcibep-liga) by the FDA marks a significant advancement for the cardiovascular treatment landscape, particularly for patients with high cholesterol levels, including heterozygous familial hypercholesterolemia (HeFH) [1][2][4]. Group 1: Product Overview - LEROCHOLTM is a third-generation PCSK9 inhibitor designed to help patients achieve and maintain LDL-C control targets, with a low immunogenicity profile and excellent safety [2][3]. - The product allows for self-administration with a single subcutaneous injection once a month, offering convenience and stability for patients [2]. - In global Phase III clinical trials involving over 2,900 patients, LEROCHOLTM demonstrated a sustained LDL-C reduction of ≥60% in cardiovascular disease patients and a 59% reduction in HeFH patients [2][3]. Group 2: Clinical Trial Results - The Phase III clinical trial in China for LEROCHOLTM has shown promising results, achieving primary efficacy endpoints for LDL-C reduction and demonstrating good safety and tolerability compared to placebo [3]. - The ongoing high prevalence of elevated LDL-C levels among cardiovascular disease patients highlights the unmet medical needs in this area, with only about 14% of the 400 million individuals with dyslipidemia in China receiving treatment [3]. Group 3: Market Potential - The PCSK9 inhibitor market in China is projected to grow significantly, with an estimated market size of approximately RMB 3 billion in 2024, reflecting a 95% year-on-year increase [6]. - By 2030, the market is expected to expand to around RMB 10 billion, indicating substantial growth potential for LEROCHOLTM, which benefits from a patent exclusivity period until 2039 [6]. Group 4: Commercialization Strategy - The FDA approval of LEROCHOLTM represents a strategic milestone for the company in the cardiovascular and metabolic field, with plans to submit a BLA in China in the first half of next year [1][5]. - The company has established a comprehensive commercialization system that integrates medical insights, market access, and sales, which has been successfully validated in other therapeutic areas [5].