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这款进口药退出!PCSK9药物竞争加剧 降脂药下个风口剑指何方?|财经解药
Xin Lang Cai Jing· 2025-08-07 10:15
Core Insights - Sanofi has confirmed the cessation of the promotion of its PCSK9 inhibitor, Alirocumab, in the Chinese market due to global supply issues and a strategic upgrade in its cardiovascular product line [2][3] - The exit of Alirocumab from the market has opened opportunities for domestic pharmaceutical companies to enter the PCSK9 inhibitor space [1][3] Industry Overview - PCSK9 inhibitors are considered a milestone in lipid-lowering therapies, with significant implications for managing high LDL cholesterol levels, which are primarily influenced by genetic factors [1][3] - The understanding of lipoprotein(a) [Lp(a)] in cardiovascular diseases has led to increased interest in developing new lipid-lowering drugs targeting this specific marker [1][7] Market Dynamics - The market for lipid-lowering medications is competitive, with established statin drugs and newer PCSK9 inhibitors being used in combination for optimal patient outcomes [4][5] - There are currently seven approved PCSK9 inhibitors in China, including both imported and domestic products, with ongoing developments from various companies [5][6] Emerging Opportunities - Companies are actively pursuing the development of alternative medications in light of Alirocumab's market exit, indicating a robust interest in the PCSK9 inhibitor segment [3][6] - The market is also seeing advancements in therapies targeting Lp(a), with several multinational corporations engaged in clinical trials for new drugs aimed at lowering Lp(a) levels [7]
诺华(NVS.US)“一年两针”长效降脂药启动新III期临床
Zhi Tong Cai Jing· 2025-08-05 13:11
Core Viewpoint - Novartis (NVS.US) has registered a Phase III clinical trial for inclisiran aimed at evaluating its efficacy and safety in patients with acute coronary syndrome (ACS) during early hospitalization [1] Group 1: Clinical Trial Details - The trial is a multicenter, randomized, double-blind, placebo-controlled study involving patients who have recently experienced ACS, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) [1] Group 2: Drug Background - Inclisiran is the first approved PCSK9siRNA drug globally, receiving approval from the EU and FDA in 2020 and 2021 for the treatment of adult hypercholesterolemia and mixed dyslipidemia, demonstrating the therapeutic potential of small nucleic acid drugs in chronic disease management [1] - To date, inclisiran has been approved for four indications in the EU, three indications in the US, and four indications in China [1]