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小核酸行业深度:技术平台和适应症不断验证,迎来销售和临床密集兑现期
Huafu Securities·2025-03-31 08:36

Investment Rating - The industry investment rating is "Outperform" (maintained) [1] Core Insights - The small nucleic acid drug industry is entering a critical period of sales and clinical validation, with significant technological advancements and expanding indications [3][4] - 2025 is identified as a pivotal year for investment in small nucleic acid drugs due to the maturity of delivery platforms like GalNac, the potential for expanded indications, and a surge in catalytic developments [3] Summary by Sections Investment Logic - 2025 is expected to be a crucial year for small nucleic acid drugs due to the maturity of the GalNac delivery platform, potential for further indication expansion, and a concentration of catalysts for small nucleic acid drugs [3] Technological Breakthroughs - The GalNac delivery system has significantly advanced small nucleic acid drug development by providing efficient liver targeting and reduced toxicity compared to previous systems like LNP [3][4] Indication Breakthroughs - Small nucleic acid drugs are transitioning from rare diseases to chronic diseases and larger disease areas, with successful clinical data emerging for conditions like hyperlipidemia and hepatitis [3][4] Catalysts for Small Nucleic Acid Drugs - Major products are expected to launch in 2025, including Novartis' Inclisiran and Alnylam's Vutrisiran and Fitusiran, with several key clinical data readouts anticipated [3] Recommended Companies - Domestic companies to watch include Heng Rui Medicine, Zhengda Tianqing, and Xinlitai, while international companies include Alnylam, Ionis, and Arrowhead [3] Market Growth - The small nucleic acid drug market has grown from $2 billion in 2018 to $3.8 billion in 2022, with significant potential in treating common diseases [29] Regulatory Framework - The regulatory framework for small nucleic acids is more developed in Europe and the US, with China gradually emphasizing the importance of small nucleic acid technology development in various policy documents [65][66] Industry Chain Analysis - The small nucleic acid industry chain includes upstream nucleoside and reagent manufacturers, midstream research and drug production companies, and downstream commercialization [69]