证券代码：002294 证券简称：信立泰 编号：2025-051 深圳信立泰药业股份有限公司 关于 JK07、JK06 境外临床试验进展的公告 基于 JK07 具有同时靶向心肌功能障碍和肺血管系统的潜力，JK07 在左心疾 病所致的肺动脉高压的临床方案（RENEU-PH）已获得 FDA 批准，并启动 IIa 期临床研究。 JK07 的 IIa 期临床试验（RENEU-PH）为开放标签、剂量递增研究，旨在评 估 JK07 在左心疾病所致的毛细血管前和毛细血管后肺动脉高压（cpcPH）患者 中的安全性、有效性和耐受性。试验为期 6 个月，计划入组不超过 30 名患者。 这些患者将在 13 周内接受四次、每四周一次（QW4）的 JK07 给药，随后进行 12 周随访。 由左心疾病引起的肺动脉高压是心衰患者的一个重要并发症，目前尚无获批 的治疗方案。流行病学研究显示，高达 50%的 HFrEF 或 HFpEF 患者表现出不同 程度的肺动脉高压，而 cpcPH 会导致预后显著恶化，如增加患者住院率、死亡 率等。 3、JK07（重组人神经调节蛋白 1（NRG-1）-抗 HER3 抗体融合蛋白注射液） 是公司自主研发、具有 ...

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。 近日，深圳信立泰药业股份有限公司（下称"公司"）收到国家药品监督管 理局核准签发的受理通知书，公司自主研发的创新小分子药物 SAL0140 片（项 目代码：SAL0140）新适应症临床试验申请获得受理。 现就相关信息公告如下： 证券代码：002294 证券简称：信立泰 编号：2025-050 深圳信立泰药业股份有限公司 关于 SAL0140 药品临床试验申请获得受理的公告 一、药品基本情况 药品名称：SAL0140 片 申请事项：境内生产药品注册临床试验 受理说明：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 自受理之日起 60 日内，未收到药审中心否定或质疑意见的，申请人可以按 照提交的方案开展临床试验。 公司本次提交的申请为 SAL0140 用于治疗原发性醛固酮增多症（PA，简称 "原醛症"）的临床试验申请。 二、其他相关情况 SAL0140 是公司具有自主知识产权的醛固酮合酶抑制剂，拟开发适应症包 括未控制高血压（包括难治性高血压）、慢性肾脏病（CKD）、原发性醛固酮增 多症等 ...

Group 1 - In the past five trading days, a total of 196 companies were investigated by institutions, with a significant focus on companies like Jingzhida, Xinlitai, and Enhua Pharmaceutical [1] - Among the companies investigated, 29 received attention from more than 20 institutions, with Jingzhida being the most popular, attracting 138 institutions [1] - The types of institutions involved in the investigations included 171 securities companies, 118 fund companies, and 57 private equity firms, indicating a strong interest from the securities sector [1] Group 2 - In terms of capital inflow, 8 out of the 29 companies that attracted more than 20 institutions saw net capital inflows, with Dangsheng Technology receiving the highest net inflow of 293 million yuan [1] - The performance of the investigated stocks showed that 12 companies experienced price increases, with Shen Gong Co., Jingzhida, and Xinlitai leading with gains of 31.80%, 17.68%, and 15.81% respectively [2] - Conversely, 17 companies saw declines, with Han Zhong Precision, Kexing Pharmaceutical, and Gao Weida experiencing the largest drops of 13.31%, 9.84%, and 9.25% respectively [2] Group 3 - The most frequently investigated company was Binglun Environment, which was surveyed 4 times, while Hu Dian Co. and Fule New Materials were investigated 3 and 2 times respectively [1] - The detailed list of companies investigated includes various sectors such as machinery, pharmaceuticals, and electronics, highlighting a diverse interest from institutions [2][3]

Market Performance - The market saw an increase last week, with the China Securities Xinhua National Brand Index rising by 1.10% to 2019.88 points [1] - The Shanghai Composite Index rose by 0.21%, the Shenzhen Component Index by 1.06%, the ChiNext Index by 1.96%, and the CSI 300 Index by 1.07% [1] Strong Performing Stocks - Notable strong performers included Hu Silicon Industry, which increased by 19.75%, and Anji Technology, which rose by 19.05% [1] - Other significant gainers included Xinlitai (up 15.81%), Yangguang Power, and Zhongwei Company (both over 14%) [1] Year-to-Date Performance - Since the beginning of the second half of the year, Zhongji Xuchuang has surged by 183.63%, leading the gains [2] - Yangguang Power and Kewo Si have also shown substantial increases of 132.40% and 82.81%, respectively [2] Market Outlook - Starstone Investment suggests that the market's trading sentiment has declined due to risk aversion ahead of the long holiday, but this may indicate that funds are waiting for clearer policy and fundamental information [2] - The overall market remains strong, with no systemic risks identified, and various sectors are expected to present opportunities [2] Sector Rotation - Source Le Sheng Asset notes a clear rotation pattern this year, with sectors such as new consumption, innovative pharmaceuticals, technology, and high-dividend stocks experiencing alternating rises [3] - The investment strategy has been adjusted to reduce the proportion of technology stocks while increasing exposure to the manufacturing sector, focusing on technology, non-ferrous metals, manufacturing, and innovative pharmaceuticals [3]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4][6]. Core Viewpoints - The report emphasizes that the Chinese pharmaceutical industry has completed the transition from old to new growth drivers, particularly highlighting the significant potential of innovative drugs. The report suggests that the industry is expected to rebound in the second half of 2025, driven by innovation and the aging population [53][54]. Summary by Sections Industry Performance - From September 22 to September 26, the pharmaceutical index fell by 2.20%, underperforming the CSI 300 index by 3.27%. The report notes a significant adjustment in small-cap stocks since August, but anticipates a stabilization and rebound in innovative drugs due to upcoming catalysts such as ESMO and BD meetings [5][34]. Company Focus: Xinlitai - Xinlitai has made significant strides in its innovative research and development, particularly in the cardiovascular-kidney-metabolism (CKM) chronic disease area. The company has a comprehensive pipeline covering hypertension, dyslipidemia, heart failure, and metabolic diseases, with multiple products already in clinical stages [3][9][15]. - The company’s innovative drug revenue accounted for 58% of its total drug revenue in the first half of 2025, indicating a strong shift towards innovation-driven growth [9][30]. Investment Recommendations - The report recommends focusing on companies that are well-positioned in the innovative drug sector, such as Xinlitai, Healer Pharmaceutical, and others. It also highlights the importance of companies with improving performance and low valuation levels, particularly in the CXO and supply chain sectors [6][53][54]. Market Trends - The report identifies several key trends driving the pharmaceutical industry, including the acceleration of aging demographics, the growth of chronic disease demand, and the increasing importance of innovative drugs in the market. It also notes that the healthcare payment system is evolving to support these trends [53][54]. Performance of Individual Stocks - The report lists top-performing stocks during the week, with Xinlitai showing a 16% increase. Conversely, it notes significant declines in stocks like Borui Pharmaceutical, which fell by 38% [34][36]. Future Outlook - The report anticipates that the pharmaceutical industry will continue to see structural growth, particularly in innovative drugs and medical devices, as well as in the aging population and outpatient consumption sectors. It suggests that companies with strong innovative capabilities and those involved in overseas expansion will be key beneficiaries [53][54].

Industry Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The innovative drug sector is experiencing a positive trend with significant revenue growth and a reduction in losses, indicating a potential for sector-wide profitability [2][6] - The overall revenue for the innovative drug sector in H1 2025 reached 30.649 billion yuan, a year-on-year increase of 9.77%, while the net loss attributable to shareholders was 2.096 billion yuan, showing a substantial reduction in losses [6] - The sector's gross margin remains high at 84.43%, with a slight decrease compared to the previous year, but showing signs of recovery in Q2 2025 [3][6] Summary by Sections Innovative Drug Sector - The innovative drug sector's revenue for H1 2025 was 30.649 billion yuan, with a growth rate of 9.77% year-on-year. Q2 2025 revenue was 16.387 billion yuan, reflecting a 33.24% increase [5][6] - The sector's gross margin for H1 2025 was 84.43%, slightly down from the previous year, but Q2 2025 saw an increase to 84.73% [3][6] - The number of License-out transactions with upfront payments exceeding 10 million USD reached a new high, indicating that overseas rights have become a crucial funding source for Chinese companies [4][7] Financial Performance - The innovative drug sector's net loss for H1 2025 was 2.096 billion yuan, with a significant reduction in losses of 127.58% year-on-year. The adjusted net loss was 2.880 billion yuan, reflecting a 151.25% reduction in losses [5][6] - The sector's operating cash flow was positive at 210 million yuan, indicating improved financial health [5] Traditional Pharmaceutical Sector - The traditional pharmaceutical sector, comprising 136 listed companies, reported total revenue of 254.895 billion yuan in H1 2025, a decrease of 1.64% year-on-year. The net profit attributable to shareholders was 32.099 billion yuan, down 4.83% [26][32] - The gross margin for the traditional pharmaceutical sector was 51.05% in H1 2025, showing a slight increase compared to the previous year [27][32] - The sector is adapting to policy changes, with increased industry concentration and some leading companies achieving growth through transformation and international expansion [32]

Core Insights - The company held a roadshow in Shenzhen, attracting over 100 institutions, including IDG Capital and Anxin Fund, to discuss its strategy, R&D progress, and market positioning [1] - The company focuses on chronic disease management (CKM) with a commitment to integrity and long-termism, aiming to become a leader in the treatment of CKM syndromes [2] Financial Performance - In the first half of 2025, the company reported a revenue growth of 4.3% year-on-year, with Q2 showing a significant rebound of 12.3%, and new product revenue accounting for over 50% of total revenue [3] - The company maintains a low debt ratio and substantial cash reserves, with R&D investment consistently above 20% of revenue [3] R&D Pipeline - The company has a robust R&D pipeline in hypertension and related CKM diseases, with various drug types including oral small molecules and combination therapies, some of which are in clinical II/III phases [4] - The company is developing innovative drugs for resistant hypertension, including SAL0140 and SAL0120, and has a focus on improving patient compliance through small nucleic acid products [4][5] Market Strategy - The company has six patented drugs in the hypertension and metabolic disease sectors, with four hypertension products forming a differentiated matrix, two of which are in the medical insurance negotiation phase [6] - The company emphasizes academic promotion and patient education while exploring digital chronic disease management models for comprehensive patient lifecycle management [6] Q&A Highlights - During the Q&A session, the company addressed various market concerns, including the focus on clinical research for JK07, the independent operation of its U.S. subsidiary, and the use of AI to enhance R&D efficiency [7]

Company Strategy - The company focuses on unmet clinical needs, with a commitment to long-term growth and innovation in the cardiovascular-kidney-metabolic (CKM) disease area [4] - It aims to create social value and has established a strong brand in the chronic disease sector, particularly in hypertension and metabolic diseases [4] - The company has six patented drugs targeting hypertension and metabolic diseases, with plans to become the leading brand in hypertension medications in China [4][6] Recent Business Performance - In the first half of 2025, the company's revenue grew by 4.3% year-on-year, with a notable rebound of 12.3% in Q2 [6] - New product revenue now accounts for over 50% of total revenue, indicating successful market penetration [6] - The company maintains a low debt ratio and strong cash reserves, with R&D investment consistently above 20% of revenue [6] R&D Pipeline - The company has 74 new drugs in development, including 51 chemical drugs and 23 biological drugs, with over 50 projects focused on CKM diseases [7] - R&D efforts are supported by platforms in both China and the U.S., utilizing AI to enhance drug discovery and development efficiency [7][8] - The company is developing a comprehensive pipeline for hypertension treatments, aiming for a range of administration methods from daily to quarterly dosing [8] Innovative Drug Development - The company is advancing several first-in-class and best-in-class products for blood lipid management, including a monoclonal antibody for PCSK9 [11] - It is also exploring unique mechanisms for metabolic diseases, focusing on energy metabolism and muscle metabolism to address obesity and diabetes [11][19] - The company is committed to integrating innovation with healthcare policies to ensure rapid clinical application of research outcomes [8] Market Strategy - The company emphasizes academic promotion and patient education to enhance product penetration and disease awareness [14] - It is exploring digital chronic disease management models to improve patient lifecycle management and commercialize chronic disease treatments [14] - The company aims to leverage its products' entry into medical insurance to expand market coverage [14] Clinical Needs and Challenges - Cardiovascular diseases remain the leading cause of death globally, with significant unmet clinical needs in hypertension management [5] - The company recognizes the complexity of hypertension mechanisms and aims to provide tailored treatment solutions for various patient demographics [9][10] - The focus on differentiated strategies in a competitive market is crucial for establishing a unique position in the metabolic disease sector [19]

据天眼查APP显示，深圳信立泰药业股份有限公司成立于1998年11月03日。注册资本111481.6535万人民 币。（数据宝） （文章来源：证券时报网） 数据宝统计，截至10:35，信立泰成交额10.15亿元，创2020年7月27日以来新高。最新股价上涨2.72%， 换手率1.43%。上一交易日该股全天成交额为8.69亿元。 ...

Core Insights - On September 25, 2023, Shenzhen Xinlitai Pharmaceutical Co., Ltd. saw a stock price increase of 5.05%, reaching 63.28 CNY per share, with a trading volume of 313 million CNY and a turnover rate of 0.45%, resulting in a total market capitalization of 70.546 billion CNY [1] Company Overview - Shenzhen Xinlitai Pharmaceutical Co., Ltd. was established on November 3, 1998, and went public on September 10, 2009. The company is located at 37th Floor, Main Building, Green View Plaza, Chegongmiao, Shenzhen, Guangdong Province [1] - The company's main business involves the research, production, and sales of pharmaceuticals and medical devices. The revenue composition is as follows: formulations 81.69%, medical devices 8.54%, raw materials 7.17%, and others 2.59% [1] Fund Holdings - According to data from the top ten holdings of funds, Hongtu Innovation Fund has a significant position in Xinlitai, with its Hongtu Innovation Healthcare Stock Fund (010434) holding 615,300 shares, accounting for 9.94% of the fund's net value, making it the largest holding [2] - The Hongtu Innovation Healthcare Stock Fund was established on October 20, 2020, with a current size of 293 million CNY. Year-to-date returns are 55.78%, ranking 413 out of 4220 in its category, while the one-year return is 65.67%, ranking 1280 out of 3820 [2] - The fund manager, Liao Xinghao, has been in position for 3 years and 308 days, with total assets under management of 476 million CNY. The best fund return during his tenure is 66.47%, while the worst is 47.49% [2]