金新制药的主要推荐逻辑基于三点。首先是其主业的企稳回升。在 2020 年和 2021 年医药集采最为激烈时，金新制药作为传统仿制药企业，许多品种如瑞 舒伐他汀、匹伐他汀、舍曲林等已完成集采。公司通过拓展院外市场，实现了 收入和利润的稳定增长。2024 年，公司扣非归母净利润约为 6.3 亿元，未来 几年仍有望实现双位数增长。今年（2025 年），预计扣非净利润可达 7 亿元， 总利润约 8 亿元，对应市值支撑在 100-120 亿元。 第二点是蒂达西尼，这是 一款从海外引进的创新失眠药物，在 2024 年 11 月成功进入医保，其价格远 超市场同类仿制药。今年（2025 年）放量迅速，预计可达到 1.8-2 亿元，而 市场预期仅为 5-8 亿元。未来有望突破 20 亿销售额，对应市值可达 60 亿。 第三点是口服 LPA 小分子研发进度领先全球，目前正在与海外 MNC 进行深度 谈判。如果按恒瑞交易估值八折计算，其 BD 交易估值至少在 15-20 亿美元， 对应市值约 100 亿。因此，如果这三步逻辑逐步兑现，金新制药市值有望达到 300 亿。 蒂达西尼在市场中的表现如何？ 京新药业 20250926 摘要 ...

Core Viewpoint - The study reveals a lactate-METTL16-CTCF signaling axis that links metabolic stress to immune evasion in diabetes-related pancreatic ductal adenocarcinoma (PDAC), suggesting potential strategies for enhancing immunotherapy in metabolically dysregulated pancreatic cancer [2][8]. Group 1: Research Findings - Tumor-associated Schwann cells (TASC) are remodeled under metabolic stress, serving as a key mediator of immune suppression in diabetes-related PDAC [4][7]. - A specific TASC subpopulation enriched in diabetes-related tumors was identified, characterized by METTL16, CD276, and NECTIN2, which impairs CD8+ T cell function and promotes PD-1 resistance [4][7]. - Lactate enters TASC via MCT1/MCT4, inducing lactylation of METTL16, enhancing CTCF stability, and activating immune suppressive ligands [5][7]. Group 2: Therapeutic Implications - Reducing METTL16 levels in Schwann cells can restore immune surveillance and increase tumor sensitivity to PD-1 blockade therapy [5][7]. - Rosuvastatin, a commonly used statin, was found to directly bind METTL16 and reduce its activity, leading to decreased immune suppressive molecules and increased CD8+ T cell proportions in diabetes-related PDAC patients [5][7]. - The combination of rosuvastatin with immunotherapy significantly enhances treatment efficacy in these patients [5][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].

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry as of May 11, 2025 [1]. Core Insights - The A-share innovative drug sector saw a weekly increase of 2.33%, outperforming the CSI 300 index by 0.33 percentage points, while the biopharmaceutical sector rose by 0.75% [2][17]. - In the past six months, the A-share innovative drug sector has cumulatively increased by 5.43%, outperforming the CSI 300 index by 9.13 percentage points, whereas the biopharmaceutical sector has decreased by 10.55% [2][17]. - The Hong Kong innovative drug sector experienced a decline of 2.14%, underperforming the Hang Seng Index by 3.75 percentage points, with a cumulative increase of 22.08% over the past six months [2][20]. - The XBI index in the US fell by 8.59% this week, with a cumulative decline of 22.72% over the past six months [2][23]. Summary by Sections Domestic Key Innovative Drug Progress - In May, one new drug was approved for market launch in China, with no new indications approved [3][41]. Overseas Key Innovative Drug Progress - In May, there were no NDA or BLA approvals in the US, Europe, or Japan for innovative drugs [4][45]. Global Key Innovative Drug Transaction Progress - A total of 12 key transactions occurred globally this week, with one disclosed transaction amounting to 415 million USD between Alchemab Therapeutics and Eli Lilly [5]. Market Performance - The report indicates that 39 stocks in the innovative drug sector rose while 67 fell during the week, with the top gainers being HaiChuang Pharmaceutical-U (22.76%), Changchun High-tech (8.99%), and Zhongsheng Pharmaceutical (8.98%) [2][16]. - The top decliners included Fuhong Hanlin (-12.64%), Connaught-B (-12.40%), and Boan Biotechnology (-11.77%) [2][16]. Clinical Trials and Approvals - In May, there were 23 newly announced clinical trials in China, including 17 in BE/I phase, 4 in II phase, and 2 in III phase [31].