证券代码：002294 证券简称：信立泰 编号：2024-048 深圳信立泰药业股份有限公司 关于增资子公司 一、对外投资概述 Salubris Biotherapeutics, Inc.的公告 （一） 基本情况 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有 虚假记载、误导性陈述或重大遗漏。 Salubris Biotherapeutics, Inc.（下称"Salubris Bio"）为深圳信立泰药业股份 有限公司（下称"信立泰"或"公司"）位于美国的创新生物制药研发中心，由 公司通过全资子公司诺泰国际有限公司（下称"香港诺泰"）等公司实现逐级控 股。为进一步支持创新生物制药发展，加快生物药海外研发进程，公司拟以自筹 资金 5,000 万美元（或等值其他币种，约合人民币 35,037 万元，以实际投资时汇 率折算额为准）向 Salubris Bio 增资。 增资完成后，公司对 Salubris Bio 的投资总额将由人民币 97,154.32 万元增至 人民币 132,191.32 万元（最终以实际投资时汇率折算额为准），Salubris Bio 仍为 公司控股子公司。 （二） 董事会审议 ...

Investment Rating - The report assigns an "Accumulate" rating to the company with a target price of 37.62 CNY based on a projected P/E ratio of 66 times for 2024 [3][6]. Core Insights - The company is a leading player in the cardiovascular field in China, focusing on innovative drug development and expanding its product pipeline, particularly in chronic disease management [2][11]. - The impact of centralized procurement on the company's performance has largely dissipated, allowing for a return to high growth driven by innovative drugs [2][20]. - The company has successfully renewed its medical insurance contracts with minimal price reductions, indicating a stable revenue outlook [2][23]. Summary by Sections Section 1: Expansion and Innovation - The company has been actively transforming and increasing R&D investments, leading to a rich pipeline of innovative products that have recently received approvals [2][14]. - The impact of centralized procurement on the company's major products has been significantly reduced, with a shift in revenue focus towards innovative drugs expected to drive growth [2][20]. Section 2: Cardiovascular Product Strategy - The flagship product, Alisartan (信立坦), is the first domestic ARB with high clinical recognition, and its sales have shown strong recovery post-medical insurance negotiations [2][29]. - The company is developing new combination formulations and has promising candidates like S086 and JK07, which are expected to enhance its market position in hypertension and heart failure treatments [2][2][29]. Section 3: Diversification into New Fields - The company is expanding into nephrology, oncology, and other therapeutic areas, aiming to create a second growth curve [2][3]. - The recent approval of innovative drugs like Enadustat and the upcoming launch of long-acting formulations indicate a strategic move to address unmet medical needs [2][18]. Section 4: Financial Projections - The company is projected to achieve earnings per share of 0.57 CNY, 0.62 CNY, and 0.71 CNY for 2024, 2025, and 2026 respectively, reflecting a strong growth trajectory [3][5]. - Revenue is expected to grow significantly, with forecasts of 4,011 million CNY in 2024, 4,517 million CNY in 2025, and 5,421 million CNY in 2026 [5].

Investment Rating - The report assigns an "Accumulate" rating to the company with a target price of 37.62 yuan based on a projected 66 times price-to-earnings ratio for 2024 [4][7]. Core Views - The company is a leading player in the cardiovascular field in China, focusing on innovative drug development and expanding its product pipeline. The impact of centralized procurement has largely cleared, allowing for a return to high growth in revenue [3][12]. - The company has a strong product lineup, with its flagship product, "Xinglitai" (Aliskiren), showing significant clinical recognition and sales recovery post-medical insurance negotiations [3][31]. - The company is actively exploring new fields, including nephrology, orthopedics, oncology, and small nucleic acid drugs, aiming to establish a second growth curve [3][4]. Summary by Sections Section 1: Expansion and Innovation - The company has been steadily expanding its presence in chronic disease management, particularly in cardiovascular treatments, with a rich pipeline of innovative products [3][12]. - The impact of centralized procurement on the company's performance has diminished, and it is expected to enter a phase of significant growth driven by innovative drugs [3][23]. Section 2: Deep Layout in Cardiovascular Diseases - "Xinglitai" is recognized as the first domestic ARB (Angiotensin Receptor Blocker) with strong clinical performance, and its sales are recovering following successful medical insurance negotiations [3][38]. - The company has developed additional products like S086 and other combination formulations to strengthen its market position in hypertension treatment [3][21]. Section 3: New Field Exploration - The company is diversifying into new therapeutic areas, including nephrology and oncology, with promising products like Enadustat and long-acting Teriparatide [3][4]. - Plans to spin off its medical device subsidiary for a separate listing are underway, which is expected to enhance operational efficiency [3][4]. Section 4: Financial Forecast and Investment Recommendations - The company is projected to achieve earnings per share of 0.57, 0.62, and 0.71 yuan for 2024, 2025, and 2026, respectively, indicating substantial growth potential [4][6]. - The report highlights that the company’s revenue is expected to recover and grow significantly in the coming years, driven by innovative drug launches and a strong market position [4][6].

深圳信立泰药业股份有限公司（下称"公司"）于近日接到公司控股股东信 立泰药业有限公司（下称"香港信立泰"）的通知，获悉其将所持有的本公司部 分股份质押及解除部分股份质押。具体情况如下： | 一、本次股东股份质押及解除质押基本情况 | | --- | | | | 是否为控 股股东或 | 本次质 | 占其所 | 占公司 | 是否 | 是否 | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 股东名 | | 第一大股 | 押数量 | 持股份 | 总股本 | 为限 | 为补 | 质押起 | 质押到期日 | 质权人 | 质押 | | 称 | | | （万 | | | | 充质 | 始日 | | | 用途 | | | | 东及其一 | 股） | 比例 | 比例 | 售股 | 押 | | | | | | | | 致行动人 | | | | | | | | | | | 信立泰 | | 控股股 | | | | | | | 至质押双方向中国 | 集友银 | 自身 | | 药业有 | | 东、第一 | | | | ...

证券研究报告 医药生物 证券分析师 刘闯 S1350524030002 liuchuang@huayuanstock.com 李强 S1350524040001 Liqiang01@huayuanstock.com 市场表现： -17.00% 3.00% 23.00% 信立泰 沪深300 相关研究 首次覆盖报告 2024 年 09 月 13 日 信立泰 (002294.SZ ) 买入（首次覆盖） ——创新药商业化渐入佳境，在研管线持续丰富 投资要点： ➢ 公司事件：公司发布 2024 年半年报，2024 上半年实现营业收入 20.4 亿元，同比增长 21.3%，实现归母 净利润 3.4 亿元（同比增长 1.9%）；24Q2，实现营业收入 9.5 亿元，同比增长 19.4%，实现归母净利润 1.4 亿元（同比增长 13.5%），符合市场预期。 ➢ 创新药商业化推广加大，销售费用率有所增长。毛利率方面，24H1 公司整体毛利率为 71.1%，23 年同 期为 68.9%，预计主要系高毛利率创新药占比提升所致；费用率方面，2024 上半年，公司销售、管理和 研发费用率分别为 36.3%、6.6%和 9.9%，23 ...

Investment Rating - The investment rating for the company is "Buy," indicating an expected return exceeding 10% relative to the CSI 300 index over the next six months [5]. Core Views - The company has achieved comprehensive growth in its main business segments, with a reported revenue of 2.043 billion yuan for the first half of 2024, representing a year-on-year increase of 21.28%. The net profit attributable to shareholders reached 344 million yuan, up 1.92% year-on-year [2][3]. - The company is advancing its innovation pipeline, with multiple projects currently in Phase III clinical trials. The R&D investment for the first half of 2024 was 460 million yuan, accounting for 22.51% of revenue [2][3]. - The gross margin has improved, reaching 71.13%, an increase of 2.20 percentage points compared to the previous year. The company has sufficient cash reserves of 938 million yuan, which supports ongoing R&D efforts [2][3]. Summary by Sections Financial Performance - For the first half of 2024, the company's revenue from raw materials was 234 million yuan (up 15.73%), from formulations was 1.631 billion yuan (up 19.54%), and from medical devices was 137 million yuan (up 49.62%). Other revenues amounted to 40 million yuan (up 55.31%) [2]. - The basic earnings per share for the first half of 2024 was 0.31 yuan, reflecting a year-on-year increase of 3.33% [2]. R&D and Innovation - The company has two products approved for market launch and four products under application for approval. The R&D pipeline is progressing well, with ongoing patient recruitment for clinical trials [2][3]. Market Position and Outlook - The company is expected to see continued revenue growth, with projected diluted EPS of 0.56 yuan, 0.64 yuan, and 0.75 yuan for 2024-2026, corresponding to dynamic P/E ratios of 49.51, 43.77, and 37.27, respectively [3].

Investment Rating - The report maintains a "Buy" rating for the company [3] Core Views - The company's performance in H1 2024 met expectations, with a revenue of 2.043 billion yuan, a year-on-year increase of 21.28%, and a net profit of 344 million yuan, up 1.92% year-on-year. The second quarter saw a revenue of 952 million yuan, growing 19.44% year-on-year, and a net profit of 144 million yuan, increasing 13.54% year-on-year [1] - The report highlights the gradual formation of a commercialization ladder for chronic disease products, with significant growth in both innovative and generic drug segments [1] Financial Performance - In H1 2024, R&D investment reached 460 million yuan, accounting for 22.51% of revenue, while sales expenses increased by 44.24% year-on-year to 741 million yuan, representing a sales expense ratio of 36.27% [1] - The company reported a net cash flow from operating activities of 533 million yuan, a year-on-year increase of 50.81% [1] Segment Analysis 1. **Innovative Drugs**: The market share of the innovative drug "Xinlitai" increased by over 20% year-on-year. New approvals include a compound formulation for hypertension and a DPP-4 inhibitor for type 2 diabetes [1] 2. **Generic Drugs**: The impact of the "Taijia" renewal gradually diminished, with a quarter-on-quarter sales increase in H1 2024. The penetration rate of Cefuroxime Sodium improved post-collection, and revenue from Teriparatide exceeded a 50% year-on-year growth [1] 3. **Other Businesses**: Revenue from APIs grew over 15%, and medical device income increased by 49.62% year-on-year, beginning to turn profitable [1] R&D Progress - The company has submitted applications for several new drugs, including S086 for hypertension and various treatments for chronic kidney disease. The overseas pipeline is progressing well, with ongoing clinical trials for multiple candidates [1] Profit Forecast and Valuation - The profit forecast for 2024-2026 has been raised, with expected net profits of 631 million yuan, 734 million yuan, and 907 million yuan, representing year-on-year growth rates of 8.8%, 16.2%, and 23.6% respectively. The corresponding P/E ratios are projected to be 54x, 47x, and 38x [1]

Investment Rating - The investment rating for the company is "Buy" (maintained) [2] Core Views - The company is positioned as a leader in the cardiovascular chronic disease sector, with a promising pipeline of innovative products expected to contribute to revenue growth [6] - The company reported a revenue of 2.04 billion yuan for H1 2024, representing a year-on-year increase of 21.3%, and a net profit of 330 million yuan, up 8.5% [6] - The impact of price declines on existing products is gradually being released, stabilizing revenue, while new products are expected to drive future income growth [6] Summary by Sections Financial Performance - For H1 2024, the company achieved a revenue of 2.04 billion yuan, with Q2 revenue at 950 million yuan, reflecting a growth of 19.4% [6] - The net profit for H1 2024 was 330 million yuan, with Q2 net profit at 130 million yuan, showing an increase of 17.7% [6] - The company forecasts net profits of 616 million yuan, 691 million yuan, and 811 million yuan for 2024, 2025, and 2026 respectively, with corresponding PE ratios of 54.6, 48.6, and 41.4 [6][8] Product Pipeline and Innovation - The company has a rich pipeline of innovative drugs, with several products expected to be approved and launched in the near future, including SAL0107 and benzoic acid for treating hypertension and heart failure [6] - The new product, Ennadustat, was launched in June 2023 and is expected to significantly contribute to revenue after being included in the national medical insurance catalog [6] Market Position and Growth Potential - The company is experiencing a gradual decrease in the impact of price reductions from existing generic drugs, while the proportion of innovative drugs is continuously increasing [6] - The company is well-positioned for future growth with a strong focus on innovative drug development and a strategic approach to market entry [6]

证券代码：002294 证券简称：信立泰 编号：2024-043 深圳信立泰药业股份有限公司 关于"质量回报双提升"行动方案的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有 虚假记载、误导性陈述或重大遗漏。 深圳信立泰药业股份有限公司（下称"公司"或"信立泰"）为贯彻落实"活 跃资本市场、提振投资者信心"及"要大力提升上市公司质量和投资价值，要采 取更加有力有效措施，着力稳市场、稳信心"的指导思想，坚持把高质量发展作 为首要任务，因地制宜发展新质生产力，增强投资者信心，维护全体股东利益， 结合自身发展战略、经营情况及财务状况，公司制定"质量回报双提升"行动方 案。具体举措如下： 一、聚焦慢病领域，创新引领发展 信立泰始终把创新的意识、创新的精神、创新的技术融入企业发展命脉，致 力于发展成为推动国内医药工业创新、打造产业新质生产力的"领航者"。作为 创新型医药企业，公司始终致力于为慢性疾病患者提供高质量的药品和服务，凭 借持续的创新研发和精准的市场布局，加速向"中国最具影响力的创新国际化医 药企业"的目标迈进。 公司以医药制造业为主体，进行多层次产业链布局，在海外自建创新药研发 平台，在国 ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has shown a significant recovery in revenue, exceeding expectations, with innovative products gaining traction [1] - The company is actively expanding its product offerings in the cardiovascular field and is making progress in international markets [2] - The financial forecasts for 2024-2026 indicate a steady growth trajectory in both revenue and net profit, driven by new product launches and a recovery in existing product sales [2] Financial Performance Summary - For the first half of 2024, the company reported revenue of 2.043 billion yuan, a year-on-year increase of 21.28%, and a net profit attributable to shareholders of 344 million yuan, up 1.92% year-on-year [1] - The gross profit margin for the reporting period was 71.13%, an increase of 2.19 percentage points year-on-year, while the operating cash flow net amount was 533 million yuan, reflecting a year-on-year increase of 50.81% [1] - The company expects revenues of 4.04 billion yuan in 2024, 4.73 billion yuan in 2025, and 5.40 billion yuan in 2026, with respective year-on-year growth rates of 19.9%, 17.1%, and 14.3% [2] Product Development and Pipeline - The company has multiple products progressing to the registration stage, including innovative drugs for hypertension and chronic heart failure, which are expected to drive future growth [1] - The company is also advancing its international clinical trials for innovative biological drugs, indicating a strategic focus on global market expansion [1][2] Financial Projections - The projected net profit for 2024 is 670 million yuan, with expected growth rates of 15.7%, 18.0%, and 12.7% for the years 2024, 2025, and 2026 respectively [2] - The company's P/E ratios are projected to be 46X in 2024, 39X in 2025, and 35X in 2026, reflecting a positive outlook on valuation [2]