Core Viewpoint - CloudTop New Horizon (01952) shares rose over 3% following FDA approval of its cardiovascular product LEROCHOLTM (lerodalcibep-liga) for lowering LDL-C levels in adults with high cholesterol [1][2] Group 1: Company Developments - The FDA approved the biologics license application (BLA) for LEROCHOLTM, which is intended for use alongside diet and exercise to reduce LDL-C levels in patients with high cholesterol, including heterozygous familial hypercholesterolemia (HeFH) [1] - In December 2025, CloudTop New Horizon signed a licensing agreement with Haisan Bio to obtain exclusive rights for the further clinical development, registration, and commercialization of LEROCHOLTM in Greater China [1] Group 2: Product Features - LEROCHOLTM is a novel small-molecule protein-binding third-generation PCSK9 inhibitor designed to help patients achieve and maintain LDL-C control targets [2] - As the first PCSK9 inhibitor fusion protein, LEROCHOLTM has low immunogenicity and outstanding safety [2] - The product is designed for patient convenience, allowing self-administration with a single small-volume subcutaneous injection once a month, and has a long room-temperature stability of up to 3 months, making it easy for patients to store and carry [2]

Group 1: Core Insights - The FDA has approved the biologics license application (BLA) for LEROCHOL TM (lerodalcibep-liga), a cardiovascular product from LIB Therapeutics, which aims to lower LDL-C levels in adults with high cholesterol [1] - Cloudtop New Horizon has secured exclusive rights for the clinical development, registration, and commercialization of LEROCHOL in Greater China through a licensing agreement with Haisan Biotech, with plans to submit a BLA in 2026 [1] - The product is expected to drive growth in the company's cardiovascular business, with potential market entry as early as 2027 [1] Group 2: Product Advantages - LEROCHOL is a third-generation PCSK9 inhibitor with three core advantages: low immunogenicity, convenient self-administration with a monthly injection, and flexible storage for up to three months at room temperature [2] - Clinical trials involving over 2,900 patients have shown that LEROCHOL can reduce LDL-C levels by ≥60% in cardiovascular disease patients and by 59% in HeFH patients [2] - A key registration phase III clinical trial in China has demonstrated significant efficacy and safety, achieving primary and secondary endpoints related to LDL-C reduction and atherosclerotic lipid improvement [2] Group 3: Market Demand and Potential - Cardiovascular diseases are a leading cause of death globally and in China, with elevated LDL-C levels being a critical factor in severe cardiovascular events [3] - There is a significant unmet medical need in China, where approximately 400 million people have dyslipidemia, and only 14% receive lipid-lowering treatment [3] - The PCSK9 inhibitor market in China is projected to reach approximately 3 billion yuan in 2024, with a 95% year-on-year growth, and is expected to expand to around 10 billion yuan by 2030 [3] Group 4: Commercial Strategy - Cloudtop New Horizon has established an integrated system driven by scientific and commercial insights for medical, access, market, and sales collaboration, which has been validated in other therapeutic areas [3] - The company aims to leverage this system to ensure successful commercialization of LEROCHOL in the cardiovascular sector in Greater China [3]