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]
港股异动 | 云顶新耀(01952)涨超3% 乐瑞泊®获FDA批准 预计明年上半年于大中华区递交BLA