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)等。目前，SAL0140(未控制高血压)正处于I期临床阶段。 格隆汇8月28日丨信立泰(002294.SZ)公布，近日，深圳信立泰药业股份有限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)临床试验 申请获得受理。 ...

证券代码：002294 证券简称：信立泰 编号：2025-046 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。 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 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）临床试验申请获得受理。 现就相关信息公告如下： 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 受理号：CXHL2500896、CXHL2500897、CXHL2500898 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 用于治疗慢性肾脏病（CKD）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 ...

信立泰（002294）(002294.SZ)发布公告，近日，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)临床试验申请获得受理。 SAL0140若能研发成功并获批上市，将有望为更多细分领域的高血压患者及CKD患者有针对性地提供新 的用药选择，满足未被满足的临床需求，并进一步丰富公司慢病领域的创新产品管线。 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)等。目前，SAL0140(未控制高血压)正处于I期临床阶段。 ...

SAL0140 若能研发成功并获批上市，将有望为更多细分领域的高血压患者及CKD患者有针对性地提供 新的用药选择，满足未被满足的临床需求，并进一步丰富公司慢病领域的创新产品管线。 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)等。目前，SAL0140 (未控制高血压)正处于I期临床阶段。 智通财经APP讯， 信立泰(002294.SZ)发布公告，近日，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)临床试验申请获得受理。 ...

人民财讯8月28日电，信立泰（002294）8月28日晚间公告，近日，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)临床试验申请获得 受理。公司本次提交的申请为SAL0140用于治疗慢性肾脏病(CKD)的临床试验申请。 ...

8月27日，信立泰跌5.07%，截至发稿，报50.40元/股，成交4.19亿元，换手率0.73%，总市值561.87亿 元。 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%。 从基金十大重仓股角度 数据显示，诺德基金旗下1只基金重仓信立泰。诺德中小盘混合（570006）二季度持有股数3万股，占基 金净值比例为4.71%，位居第七大重仓股。根据测算，今日浮亏损失约8.07万元。 诺德中小盘混合（570006）成立日期2010年6月28日，最新规模3016.08万。今年以来收益50.57%，同类 排名462/8194；近一年收益55.46%，同类排名1974/7963；成立以来收益84.14%。 诺德中小盘混合（570006）基金经理为朱明睿。 责任编辑：小浪快报 风险提示：市场有风险，投资需谨慎。本文为AI大模型自动发布，任何在本文出现的信息（包括但 ...

Group 1 - A-share market sees a decline in several innovative drug concept stocks, with Yuekang Pharmaceutical dropping over 10% [1] - Guangshengtang falls by 8%, while Lifang Pharmaceutical and Haishike decrease by over 7% [1] - Saili Medical declines by over 6%, and Huiyu Pharmaceutical drops by over 5% [1] - Jingxin Pharmaceutical experiences a decline of over 4%, with Shutaishen, Haiteshengwu, and Xinlitai all falling by over 3% [1]

Core Viewpoint - The company has successfully transitioned from a generic drug focus to an innovative drug development strategy, particularly in the cardiovascular field, after facing significant challenges in the past five years [1][3]. Financial Performance - In the first half of the year, the company achieved operating revenue of 2.131 billion yuan, a year-on-year increase of 4.32%, with the second quarter showing a growth of 12.3% [1]. - The net profit for the same period was 365 million yuan, up 6.1% year-on-year, with a second-quarter increase of 14.6% [1]. - The company's stock price has risen over 73% year-to-date, reaching new highs [1]. Strategic Transition - The company initially focused on cardiovascular drugs and successfully launched the first generic version of a key drug, which led to significant market share and profit growth until facing challenges from market competition and price reductions [3][4]. - Anticipating the unsustainability of the generic drug market, the company began its transition to innovative drug development around 2014, selling off low-end generic projects to reinvest in innovation [3][4]. Research and Development Focus - The company has maintained a strong commitment to R&D, with a research intensity of over 20%, reaching 25.43% in the first half of the year with R&D investment of 542 million yuan [7]. - The company has developed a robust pipeline of innovative products targeting chronic diseases, particularly in the cardiovascular, renal, and metabolic areas, with over 70 new drug projects in development [8]. Product Development Achievements - The company has successfully commercialized its innovative drug, Xinlitai, which is a significant product in its portfolio, and has recently launched a new hypertension drug, Xinchao, which is the first domestically developed ARNI drug [4][5]. - The company has established a diverse technological capability to meet various patient needs, including the development of long-acting injectable formulations and exploring gene editing technologies for hereditary cardiovascular diseases [8].

Core Viewpoint - The company has undergone a significant transformation over the past five years, shifting from a focus on generic drugs to innovative drug development, particularly in the cardiovascular field, in response to market challenges and declining profits [1][2]. Financial Performance - In the first half of the year, the company achieved operating revenue of 2.131 billion yuan, a year-on-year increase of 4.32%, with the second quarter showing a growth of 12.3% [1]. - The net profit for the same period was 365 million yuan, up 6.1% year-on-year, with a second-quarter increase of 14.6% [1]. - The company's stock price has risen over 73% this year, reaching new highs [1]. Strategic Shift - The company anticipated the unsustainability of the generic drug market and began focusing on innovative drug development around 2014, selling off low-end generic drug projects to raise funds [2][3]. - The company has maintained a strong commitment to research and development, with R&D intensity exceeding 20% [4][5]. Product Development - The company has developed a robust pipeline of innovative products targeting cardiovascular diseases, including the successful launch of the new drug "Xinchao" which is the first domestic original drug in its category [3][4]. - The company has established a diverse technical capability to meet patient needs, including the development of injection drugs for improved compliance and exploring gene editing technologies for hereditary cardiovascular diseases [5]. Market Position - The company has positioned itself as a leader in the cardiovascular drug market, with a comprehensive product lineup that addresses various stages of chronic diseases [5]. - Currently, the company has six patented new drugs on the market and over 70 new drug projects in development, with four advancing to clinical phase III [5].

Core Viewpoint - The stock of Shenzhen Xinlitai Pharmaceutical Co., Ltd. has shown significant growth in 2023, with a year-to-date increase of 76.80% and notable recent trading activity [1][2]. Financial Performance - For the first half of 2025, Xinlitai achieved a revenue of 2.131 billion yuan, representing a year-on-year growth of 4.32%, while the net profit attributable to shareholders was 365 million yuan, up 6.10% [2]. - Since its A-share listing, Xinlitai has distributed a total of 7.204 billion yuan in dividends, with 1.649 billion yuan distributed over the past three years [3]. Stock Market Activity - As of August 25, 2023, Xinlitai's stock price was 53.80 yuan per share, with a market capitalization of 59.977 billion yuan [1]. - The stock has experienced a trading volume of 1.78 billion yuan on the same day, with a turnover rate of 0.30% [1]. - The stock has appeared on the "Dragon and Tiger List" twice this year, with the most recent instance on June 17, 2023, where it recorded a net buy of -41.9885 million yuan [1]. Shareholder Structure - As of June 30, 2025, Xinlitai had 24,000 shareholders, a decrease of 0.79% from the previous period, with an average of 46,403 circulating shares per shareholder, an increase of 0.80% [2][3]. - Notable shareholders include China Europe Medical Health Mixed A, which increased its holdings by 12.0972 million shares, and Hong Kong Central Clearing Limited, which increased its holdings by 1.1032 million shares [3].