证 券 研 究 报 告 [Table增_R持at（ing维] 持） | [行Ta业ble_Industry] : | 医药生物 | | --- | --- | | 日期: | 2026年02月04日 shzqdatemark | | [T分ab析le师_Author] : | 张林晚 | | Tel: | 021-53686155 | | E-mail: | zhanglinwan@shzq.com | | SAC 编号: | S0870523010001 | 行 业 周 报 [T相ab关le报_R告e：portInfo] 领域资源整合加速》 《产业化进程加速，脑机接口发展进入快 车道》 《重庆脑机接口获突破性进展，建立癫痫 治疗新范式》 我们认为，我国血脂异常人数近年显著增加，关注代谢领域PCSK9靶点 及小核酸赛道进展。建议关注：恒瑞医药、信达生物、华东医药等。 风险提示 药品/耗材降价风险；行业政策变动风险等；市场竞争加剧风险等。 诺华 siRNA 降脂药物在华获批新适应症，关 注 PCSK9 及小核酸赛道 ——医药生物行业周报（20260126-0130） [Tab主le_要Su观mm点ary] 诺华 ...

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]

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses advancements in small RNA (siRNA) drug development, particularly in the context of cardiovascular disease treatment and metabolic disorders [1][3][12]. Core Insights and Arguments - **Inclisiran as a Leading siRNA Drug**: Inclisiran demonstrates significant lipid-lowering effects similar to vaccines, requiring administration only twice a year, enhancing patient compliance [1][3]. - **Mechanism of Action**: siRNA not only clears existing target proteins but also inhibits the future production of these proteins, such as PCSK9, providing a more durable treatment effect compared to monoclonal antibodies [1][4][6]. - **Safety and Efficacy**: siRNA is considered safer than gene editing techniques as it does not alter DNA, thus minimizing risks associated with off-target effects and ethical concerns [5][6]. - **Sales Growth of Novartis' PCSK9 siRNA Product**: The product has seen rapid sales growth due to its ability to target liver cells and provide long-lasting effects, with injection intervals of up to six months or even a year [6][12]. - **Challenges in siRNA Delivery**: Effective delivery remains a significant challenge, with the Galenic system being the most mature and clinically validated for liver-targeted delivery [7][19]. - **Potential in Metabolic Weight Loss**: siRNA technology shows promise in metabolic weight loss, but further research is needed to confirm its effectiveness [8][20]. Additional Important Content - **Targeting Cholesterol and Triglycerides**: ANGPTL4 and APOC3 are highlighted as key targets for cholesterol and triglyceride management, respectively, with a focus on achieving cardiovascular benefits [8][10]. - **LPA and LDL in Cardiovascular Risk**: High levels of LPA can indicate cardiovascular risk even when LDL levels are low, suggesting that both should be targeted for optimal cardiovascular health [10]. - **Combination Therapy Potential**: Combining siRNA with statins or other oral medications can significantly enhance lipid-lowering effects, but requires careful monitoring of biochemical indicators for safety [14][15]. - **Long-term Patient Management**: Regular monitoring of biochemical markers is crucial for patients on long-term lipid-lowering therapies, especially in populations with higher intolerance to statins [15][16]. - **Future of siRNA in Clinical Practice**: siRNA drugs could potentially become first-line treatments if they demonstrate sufficient efficacy and safety through large-scale clinical trials [12][13]. Conclusion - The siRNA technology landscape is evolving, with significant potential in treating cardiovascular diseases and metabolic disorders. However, challenges in delivery systems and the need for extensive clinical validation remain critical for its future success in clinical applications [17][23].