Core Viewpoint - The FDA has approved the biologics license application (BLA) for LEROCHOL (lerodalcibep-liga), a novel cardiovascular product developed by LIB Therapeutics, which is expected to significantly enhance the long-term growth of the cardiovascular business for Cloudtop New Horizon (1952.HK) in Greater China [1][5]. Group 1: Product Overview - LEROCHOL is a third-generation PCSK9 inhibitor designed to help patients achieve and maintain LDL-C control targets, with a low immunogenic profile and excellent safety [2]. - The product allows for self-administration with a single subcutaneous injection once a month, offering convenience for patients [2]. - In global Phase III clinical trials involving over 2,900 patients, LEROCHOL demonstrated a sustained LDL-C reduction of ≥60% in cardiovascular disease patients and a 59% reduction in HeFH patients [2]. Group 2: Clinical Trial Results - The Phase III clinical trial in China has shown promising results, achieving primary efficacy endpoints for LDL-C reduction and demonstrating good safety and tolerability compared to placebo [3]. - High LDL-C levels are a key risk factor for serious cardiovascular events, and lowering LDL-C can improve patient outcomes [3]. Group 3: Market Potential - The PCSK9 inhibitor market in China is projected to grow rapidly, with a market size of approximately RMB 3 billion in 2024, reflecting a 95% year-on-year increase [6]. - By 2030, the market size is expected to expand to around RMB 10 billion, indicating significant growth potential [6]. - LEROCHOL's unique product advantages and solid clinical data, along with patent protection until 2039, position it well to capture a significant market share in a competitive landscape [6]. Group 4: Commercialization Strategy - Cloudtop New Horizon has established a comprehensive commercialization system, which has been successfully validated in other therapeutic areas, to facilitate the market penetration of LEROCHOL [5]. - The company plans to submit the BLA for LEROCHOL in Greater China in the first half of next year, with potential market entry as early as 2027 [5].
云顶新耀创新降脂药乐瑞泊®获FDA批准，预计明年上半年于大中华区递交BLA