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云顶新耀涨超3% 乐瑞泊 获FDA批准 预计明年上半年于大中华区递交BLA
Zhi Tong Cai Jing· 2025-12-17 06:28
Group 1 - The core viewpoint of the news is that Genting New Year (01952) has seen a stock increase of over 3% following the FDA approval of its cardiovascular product, LEROCHOLTM (lerodalcibep-liga), for lowering LDL-C levels in adults with high cholesterol [1] - Genting New Year reported a stock price of 48.44 HKD with a trading volume of 131 million HKD at the time of the announcement [1] - The FDA approval allows for the use of LEROCHOLTM in conjunction with diet and exercise for patients with heterozygous familial hypercholesterolemia (HeFH) [1] Group 2 - LEROCHOLTM is a novel small-molecule protein-binding third-generation PCSK9 inhibitor designed to help patients achieve and maintain LDL-C control [2] - As the first PCSK9 inhibitor fusion protein, LEROCHOLTM has low immunogenicity and outstanding safety [2] - The product is developed for patient convenience, allowing for self-administration with a single subcutaneous injection once a month, and has a long room temperature stability of up to 3 months [2]