Core Viewpoint - The company, Xinlitai (002294.SZ), has received an acceptance notice from the National Medical Products Administration for its clinical trial application of the innovative small molecule drug SAL0137, which is intended for the treatment of elevated lipoprotein(a) levels [1] Group 1 - The clinical trial application for SAL0137 has been accepted, indicating progress in the drug development process [1] - SAL0137 is a proprietary oral small molecule drug developed by the company [1] - The application specifically targets the treatment of elevated lipoprotein(a), a significant health concern [1]

证券代码：002294 证券简称：信立泰 编号：2025-052 深圳信立泰药业股份有限公司 关于 SAL0137 药品临床试验申请获得受理的公告 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。 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 SAL0137 片（项 目代码：SAL0137）临床试验申请获得受理。 申请事项：境内生产药品注册临床试验 受理号：CXHL2501108、CXHL2501109、CXHL2501110 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。 SAL0137 是公司研发的具有自主知识产权的口服小分子药物，公司本次提 交的申请为 SAL0137 用于治疗脂蛋白（a）增高的临床试验申请。 二、其他相关情况 脂蛋白（a）[lipoprotein(a), Lp(a)]水平升高是冠心病、缺血性脑卒中、外周 血管疾病、冠状动脉钙化 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial application of its innovative small molecule drug SAL0137, which is intended for the treatment of elevated lipoprotein (a) levels [1] Group 1 - The clinical trial application for SAL0137 has been accepted, indicating progress in the drug development process [1] - SAL0137 is a proprietary oral small molecule drug developed by the company [1] - The application specifically targets the treatment of elevated lipoprotein (a), a significant health concern [1]

今年以来信立泰已经2次登上龙虎榜，最近一次登上龙虎榜为6月17日，当日龙虎榜净买入-4198.85万 元；买入总计1.14亿元 ，占总成交额比12.79%；卖出总计1.56亿元 ，占总成交额比17.49%。 资料显示，深圳信立泰药业股份有限公司位于广东省深圳市福田区深南大道6009号车公庙绿景广场主楼 (B座)37层，成立日期1998年11月3日，上市日期2009年9月10日，公司主营业务涉及药品、医疗器械产 品的研发、生产、销售。主营业务收入构成为：制剂81.69%，器械8.54%，原料7.17%，其他2.59%。 10月13日，信立泰盘中下跌2.02%，截至11:06，报55.16元/股，成交2.54亿元，换手率0.41%，总市值 614.93亿元。 资金流向方面，主力资金净流出1955.39万元，特大单买入1052.33万元，占比4.15%，卖出1394.13万 元，占比5.50%；大单买入5051.37万元，占比19.92%，卖出6664.96万元，占比26.28%。 信立泰今年以来股价涨81.27%，近5个交易日跌9.07%，近20日跌5.45%，近60日涨22.55%。 截至6月30日，信立泰股东 ...

Core Viewpoint - The innovative drug concept has seen a significant surge in the market, with several companies experiencing notable stock price increases [1] Group 1: Company Performance - Changchun High-tech has risen over 8% [1] - Xinghao Pharmaceutical and Wanbangde have both increased by over 5% [1] - Other companies such as Tibet Pharmaceutical, Rongchang Bio, Xinlitai, Guangsheng Tang, and Nuocheng Jianhua have also shown upward movement in their stock prices [1]

Core Viewpoint - The stock of Shenzhen Xinlitai Pharmaceutical Co., Ltd. has experienced significant fluctuations, with a year-to-date increase of 94.35% and recent declines in the short term [1][2]. Company Overview - Shenzhen Xinlitai Pharmaceutical Co., Ltd. was established on November 3, 1998, and listed on September 10, 2009. The company is located in the Futian District of Shenzhen, Guangdong Province [1]. - The main business segments include pharmaceuticals and medical devices, with revenue composition as follows: formulations 81.69%, devices 8.54%, raw materials 7.17%, and others 2.59% [1]. Financial Performance - For the first half of 2025, Xinlitai achieved operating revenue of 2.131 billion yuan, representing a year-on-year growth of 4.32%. The net profit attributable to shareholders was 365 million yuan, with a growth of 6.10% [2]. - Since its A-share listing, the company has distributed a total of 7.204 billion yuan in dividends, with 1.649 billion yuan distributed over the past three years [3]. Shareholder Structure - As of June 30, 2025, the number of shareholders was 24,000, a decrease of 0.79% from the previous period. The average circulating shares per person increased by 0.80% to 46,403 shares [2]. - The top circulating shareholders include China Europe Medical Health Mixed A (holding 26.163 million shares), Hong Kong Central Clearing Limited (holding 15.307 million shares), and ICBC Frontier Medical Stock A (holding 15 million shares) [3].

Summary of the Conference Call for Xinlitai Company Overview - **Company**: Xinlitai - **Industry**: Pharmaceutical, focusing on hypertension and chronic disease management Key Points and Arguments Hypertension Management - Xinlitai has established a comprehensive product line for hypertension management, covering mild to resistant hypertension, and addressing complications, with expected revenue exceeding 10 billion yuan in the future [2][5][15] - The company has achieved full lifecycle management for hypertension patients, with innovative drug revenue expected to surpass 60% by the end of 2025 [2][6][15] - The JK07 project is a key focus of Xinlitai's innovation strategy, with phase II clinical enrollment completed and top-line data expected in the first half of 2026, with a peak sales potential of 20 billion USD for heart failure indications [2][4][5][21] Research and Development Investments - Xinlitai significantly increased R&D investments, with over 1 billion yuan allocated in 2024, accounting for 25% of revenue [2][6][15] - The company has diversified its R&D efforts beyond traditional small and large molecules to include ADC, peptides, cyclic peptides, gene editing, and small nucleic acids [3][5][6] Product Pipeline and Innovations - Xinlitai's innovative drugs are categorized into three dimensions: - **Innovation 1.0**: Focused on hypertension management with products like Alisartan and S086, targeting various hypertension severities [4][5] - **Innovation 2.0**: Emphasizes emerging technologies, particularly the JK07 project [5][6] - **Innovation 3.0**: Involves cutting-edge platforms such as oral cyclic peptides and gene editing, positioning Xinlitai as a leader in innovation for the next 5-10 years [5][6] Market Potential and Competitive Landscape - The Chinese hypertension market is vast, with a potential market size in the hundreds of billions, especially for innovative drugs that are effective and safe [16][17] - S086 is expected to replace existing products like Losartan in the market, with a projected market size of 6-7 billion yuan [18] - The company is actively developing two key products for male hypertension patients, 120 (ETA receptor antagonist) and 140 (aldosterone synthase inhibitor), with significant market potential [10][11] Heart Failure and Lipid Management - Xinlitai is also focusing on heart failure treatment, with JK07 showing promising results in clinical trials, and a peak sales potential of 20 billion USD [13][21] - In the lipid management sector, Xinlitai has developed a diverse product portfolio, including approved PCSK9 monoclonal antibodies and several candidates in clinical stages, indicating strong growth potential [12][8] Future Outlook - Xinlitai's revenue is expected to continue growing, with projections of over 2 billion yuan starting in 2026, driven by innovative products and strategic partnerships [22] - The company aims to evolve from a chronic disease-focused entity to a comprehensive innovative leader in the pharmaceutical industry over the next decade [22] Additional Important Insights - The company has a robust pipeline in chronic disease management, including kidney disease, diabetes, and metabolic disorders, showcasing its commitment to addressing a wide range of health issues [7][8] - The competitive landscape for hypertension drugs is evolving, with many existing products entering the generic market, which may impact pricing and market dynamics [16][18]

Group 1 - In the past five trading days, a total of 222 companies were investigated by institutions, with significant interest in companies like Siwei Technology, Borui Pharmaceutical, and Xinlitai [1][2] - Among the companies investigated, 41 received attention from more than 20 institutions, with Siwei Technology being the most popular, attracting 92 institutions [1][2] - The types of institutions involved in the investigations included 194 securities companies, 145 fund companies, and 74 private equity firms, indicating a strong interest from the securities sector [1] Group 2 - In terms of investigation frequency, two companies, Hu Dian Co. and Ice Wheel Environment, were investigated three times, indicating high interest [2] - Out of the stocks investigated by more than 20 institutions, 13 saw net inflows of funds, with Jucheng Co. receiving the highest net inflow of 297 million yuan [2] - Among the stocks investigated, 24 experienced price increases, with Jucheng Co. leading with a rise of 36.31%, while 17 saw declines, with Borui Pharmaceutical dropping by 27.33% [2][3] Group 3 - The investigation data included various companies across different sectors, with notable mentions such as Siwei Technology (92 institutions), Borui Pharmaceutical (80 institutions), and Xinlitai (78 institutions) [2][3] - The latest closing prices and percentage changes for these companies were also highlighted, showing significant volatility in the market [2][3] - The data provided a comprehensive overview of institutional interest and market performance, reflecting the dynamic nature of the investment landscape [2][3]

Core Viewpoint - Sinopharm's subsidiary Salubris Biotherapeutics has made significant progress with its innovative biologics JK07 and JK06, which are currently undergoing clinical trials for heart failure and solid tumors respectively [1][2][3] Group 1: JK07 Development - JK07 is in a Phase II clinical trial (RENEU-HF) for patients with HFrEF and HFpEF, with all patient enrollments for HFrEF completed and results expected in the first half of 2026 [1] - The trial is randomized, double-blind, placebo-controlled, and aims to assess the safety and efficacy of JK07, with a total of 215 HFrEF patients enrolled [1] - The primary endpoint for the HFrEF cohort is the change in left ventricular ejection fraction after 26 weeks of follow-up [1] Group 2: JK07 in Pulmonary Hypertension - JK07 has received FDA approval for a clinical trial (RENEU-PH) targeting pulmonary hypertension caused by left heart disease, with a Phase IIa study now initiated [2] - The study is an open-label, dose-escalation trial aimed at evaluating the safety, efficacy, and tolerability of JK07 in patients with cpcPH, planning to enroll up to 30 patients [2] - Epidemiological studies indicate that up to 50% of HFrEF or HFpEF patients exhibit varying degrees of pulmonary hypertension, which significantly worsens prognosis [2] Group 3: JK06 Development - JK06 is a selective 5T4-targeting antibody-drug conjugate (ADC) currently undergoing Phase I clinical trials in Europe, with plans for dose expansion studies by the end of the year [3] - Initial data from the Phase I trial is expected to be presented at the ESMO conference in October 2025 [3] - The trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors expressing the 5T4 protein, with a maximum enrollment of 155 patients [3]

Core Viewpoint - Sinopharm's subsidiary Salubris Biotherapeutics has made significant progress with its innovative biologics JK07 and JK06, which are currently undergoing clinical trials for heart failure and solid tumors respectively [1][2][3] Group 1: JK07 Development - JK07 is in a Phase II clinical trial (RENEU-HF) for patients with HFrEF and HFpEF, with all patient enrollments for HFrEF completed and results expected in the first half of 2026 [1] - The trial is randomized, double-blind, placebo-controlled, and aims to assess the safety and efficacy of JK07, with a total of 215 HFrEF patients enrolled [1] - The primary endpoint for the HFrEF cohort is the change in left ventricular ejection fraction after 26 weeks of follow-up [1] Group 2: JK07 in Pulmonary Hypertension - JK07 has received FDA approval for a clinical trial (RENEU-PH) targeting pulmonary hypertension caused by left heart disease, with a Phase IIa study now initiated [2] - This open-label, dose-escalation study will evaluate the safety, efficacy, and tolerability of JK07 in patients with cpcPH, aiming to enroll up to 30 patients [2] - The study duration is 6 months, with patients receiving four doses of JK07 over 13 weeks, followed by a 12-week follow-up [2] Group 3: JK06 Development - JK06 is a selective 5T4-targeting antibody-drug conjugate (ADC) currently in a Phase I clinical trial in Europe, with plans for dose expansion later this year [3] - Initial data from the Phase I trial is expected to be presented at the ESMO conference in October 2025 [3] - The trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 in patients with solid tumors expressing the 5T4 protein, with a maximum enrollment of 155 patients [3]