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 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial application of its innovative small molecule drug SAL0140, which targets uncontrolled hypertension and chronic kidney disease [1] Group 1: Product Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company [1] - The drug is currently in Phase I clinical trials for the indication of uncontrolled hypertension [1] - If successful, SAL0140 is expected to provide new treatment options for patients with uncontrolled hypertension and chronic kidney disease, addressing unmet clinical needs [1] Group 2: Market Potential - The development of SAL0140 could enrich the company's pipeline of innovative products in the chronic disease sector [1] - The targeted indications for SAL0140 include resistant hypertension and chronic kidney disease, which represent significant market opportunities [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial application of its innovative small molecule drug SAL0140, which targets uncontrolled hypertension and chronic kidney disease [1] Group 1: Product Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company [1] - The drug is currently in Phase I clinical trials for the indication of uncontrolled hypertension [1] - If successful, SAL0140 is expected to provide new treatment options for patients with uncontrolled hypertension and chronic kidney disease, addressing unmet clinical needs [1] Group 2: Market Potential - The development of SAL0140 will enrich the company's pipeline of innovative products in the chronic disease sector [1] - The targeted indications for SAL0140 include resistant hypertension and chronic kidney disease, which represent significant market opportunities [1]

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。 ...

Group 1 - The core point of the news is that Shenzhen Xinlitai Pharmaceutical Co., Ltd. experienced a stock decline of 5.07%, with a current share price of 50.40 yuan and a total market capitalization of 561.87 billion yuan [1] - The company was established on November 3, 1998, and went public on September 10, 2009. Its main business involves the research, production, and sales of pharmaceuticals and medical devices [1] - The revenue composition of the company is as follows: formulations account for 81.69%, medical devices 8.54%, raw materials 7.17%, and others 2.59% [1] Group 2 - From the perspective of fund holdings, Nord Fund has a significant position in Xinlitai, with the Nord Small and Medium Mixed Fund (570006) holding 30,000 shares, representing 4.71% of the fund's net value [2] - The Nord Small and Medium Mixed Fund was established on June 28, 2010, and has a current scale of 30.16 million. It has achieved a year-to-date return of 50.57% and a one-year return of 55.46% [2] - The fund manager, Zhu Mingrui, has been in position for 3 years and 56 days, with the best fund return during his tenure being 37.39% and the worst being -5.71% [3]

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].

Group 1 - The core viewpoint of the article highlights the performance of the E Fund Healthcare Industry Mixed A Fund, which has shown significant returns over various time frames [1] - As of August 24, 2025, the latest net value of the fund is 4.7380 yuan, with a weekly return of -0.94%, a three-month return of 31.94%, and a year-to-date return of 55.55% [1] - The fund was established on January 28, 2011, and as of June 30, 2025, it has a total scale of 3.944 billion yuan [1] Group 2 - The top ten stock holdings of the fund include companies such as Heng Rui Medicine, Rejig Bio, Xin Li Tai, BeiGene-U, Hai Si Ke, and others, with a total holding percentage of 58.14% [1] - The fund manager is Yang Zhenshao, who oversees the investment strategy and portfolio management [1]