证券代码：002294 证券简称：信立泰 编号：2025-062 登录新浪财经APP 搜索【信披】查看更多考评等级 深圳信立泰药业股份有限公司 关于SAL0140 获得临床试验批准通知书的公告 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《临床试验批 准通知书》，同意公司自主研发的创新小分子药物SAL0140片（项目代码：SAL0140）开展治疗原发性 醛固酮增多症的临床试验。 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）、原发性醛固酮增多症、慢性肾脏病（CKD）等。 醛固酮是人体最重要的盐皮质激素，通过激活盐皮质激素受体（MR）来维持体液和电解质的平衡，同 时直接参与多种心血管和肾脏疾病的靶器官损伤。醛固酮合酶抑制剂有望通过直接抑制醛固酮的合成， 降低原醛症患者的醛固酮水平，进而降低血压及器官损伤，具有一定开发潜力。 （详见2025年2月14日、2025年4月29日、2025年8月29日、2025年9月30日、20 ...

信立泰（002294）(002294.SZ)公告，公司收到国家药品监督管理局核准签发的《临床试验批准通知 书》，同意公司自主研发的创新小分子药物SAL0140片(项目代码：SAL0140)开展治疗原发性醛固酮增 多症的临床试验。 公告显示，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)、原发性醛固酮增多症、慢性肾脏病(CKD)等。 ...

公告显示，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)、原发性醛固酮增多症、慢性肾脏病(CKD)等。 智通财经APP讯，信立泰(002294.SZ)公告，公司收到国家药品监督管理局核准签发的《临床试验批准通 知书》，同意公司自主研发的创新小分子药物SAL0140片(项目代码：SAL0140)开展治疗原发性醛固酮 增多症的临床试验。 ...

格隆汇12月8日丨信立泰(002294.SZ)公布，收到国家药品监督管理局核准签发的《临床试验批准通知 书》，同意公司自主研发的创新小分子药物SAL0140片（项目代码：SAL0140）开展治疗原发性醛固酮 增多症的临床试验。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）、原发性醛固酮增多症、慢性肾脏病（CKD）等。醛固酮是人体最重要 的盐皮质激素，通过激活盐皮质激素受体（MR）来维持体液和电解质的平衡，同时直接参与多种心血 管和肾脏疾病的靶器官损伤。醛固酮合酶抑制剂有望通过直接抑制醛固酮的合成，降低原醛症患者的醛 固酮水平，进而降低血压及器官损伤，具有一定开发潜力。 ...

信立泰12月8日公告，公司收到国家药品监督管理局核准签发的《临床试验批准通知书》，同意公司自 主研发的创新小分子药物SAL0140片开展治疗原发性醛固酮增多症的临床试验。 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）、原发性醛 固酮增多症、慢性肾脏病（CKD）等。 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 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。 二〇二五年十二月四日 （详见2025年2月14日、2025年4月29日、2025年8月29日、2025年9月30日登载于信息披露媒体《中国证 券报》、《证券时报》、巨潮资讯网www.cninfo.com.cn的《关于SAL0140药品临床试验申请获得受理的 公告》、《关于SAL0140获得临床试验批准通知书的公告》） SAL0140若能研发成功并获批上市，将有望为更多细分领域的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。 公司将按国家药品注册的相关规定和要求开展临床试验，待临床试验成功后按程序注册申报。根据普遍 的行业特点，药品研发周期长、风险较高，从临床到上市受到多方面因素影响，存在不确定性，短期内 对公司业绩不会产生实际影响。公司将按规定对有关后续进展情况及时履行信息披露义务，敬请广大投 资者理性投资，注意风险。 特此公告 深圳信立泰药业股份有限公司 董事会 近日，深圳信立泰药业股份有限公司（下称"公司"） ...

今日（12.4），港药四连跌后强势反弹，创新药纯度100%的港股通创新药ETF(159570)四连跌后首次反弹涨1.5%，成交额快速突破12亿元！资金面上，此前 三日连续回调吸金，近5日累计净流入超1.8亿元！截至12月3日，港股通创新药ETF(159570)最新规模超232亿元，同类持续领先！ 消息面上，12月3日，信立泰发布公告，公司收到药监局核准签发的《临床试验批准通知书》，同意公司自主研发的创新小分子药物SAL0140片开展治疗慢 性肾脏病（CKD）的临床试验。 港股通创新药ETF(159570)标的指数权重股多数飘红：康方生物、科伦博泰生物-B、金斯瑞生物科技涨超3%，信达生物涨超2%，百济神州涨近2%，三生制 药涨近1%，中国生物制药微涨。 | 序号 | 代码 | 名称 | 估算权重 | 涨跌幅 | 成交额 | | --- | --- | --- | --- | --- | --- | | 1 | 6160 | 百济神州 | 11.90% | 2.19% | 2.99亿 | | 2 | 1801 | 信达生物 | 11.38% | 2.02% | 2.28亿 | | 3 | 9926 | 康方生物 ...

Policy Developments - The National Healthcare Security Administration announced five typical cases of fraud involving maternity insurance funds, urging insured units and individuals to participate legally and provide accurate application materials to safeguard the fund [1] Drug and Device Approvals - Dongcheng Pharmaceutical's subsidiary received a production license for radioactive drugs, with expectations that it will not significantly impact current performance until commercial production is approved [1] - Jianyou Co., Ltd. received FDA approval for its propofol emulsion injection, with an investment of approximately RMB 73.66 million in R&D, and plans to launch the product in the U.S. soon [2] - Aihong Pharmaceutical presented clinical trial data for APL-1401 at the European Colorectal Congress, focusing on treating moderate to severe ulcerative colitis [6] - Fosun Pharma's subsidiary received approval for clinical trials of FXS887, an innovative drug for treating advanced malignant solid tumors [7] - Xinlitai received approval for clinical trials of SAL0140, a novel drug for chronic kidney disease, which could provide new treatment options if successful [8] Capital Market Activities - Lexin Medical announced that its controlling shareholder, Pan Weichao, has released the pledge on 18.71 million shares, which is 28.01% of his holdings and 8.56% of the total share capital [3] - Berry Genomics reported a decrease in the shareholding ratio of its controlling shareholder, Gao Yang, to 6.90% due to stock pledge defaults, with no significant adverse impact on the company's operations [4] - Tailong Pharmaceutical is planning a major matter that may lead to a change in control, with stock suspension expected to last no more than three trading days [5] Strategic Collaborations - JD Health and Boehringer Ingelheim Animal Health signed a strategic cooperation agreement to enhance the quality development of the domestic pet health industry through resource integration and complementary advantages [10] Regulatory Actions - Guizhou Bai Ling's actual controller, Jiang Wei, is under investigation by the China Securities Regulatory Commission for insider trading and other violations, which does not affect the company's daily operations [11]

Group 1 - Guizhou BaiLing's actual controller Jiang Wei has been investigated by the China Securities Regulatory Commission (CSRC) for insider trading and information disclosure violations [1] - The investigation highlights the regulatory focus on key individuals and may increase operational uncertainty for Guizhou BaiLing, which has faced performance pressures in recent years [1] - The CSRC's actions reflect ongoing efforts to enhance the rule of law in the capital market [1] Group 2 - Jianyou Co., Ltd. has received ANDA approval from the FDA for its Propofol emulsion injection, marking a significant step in the company's internationalization of its formulations [2] - The product is expected to have a broad market potential in the U.S. as a commonly used sedative for surgeries, potentially driving revenue growth for the company [2] Group 3 - Shenzhen Xinlitai has been granted clinical trial approval for its innovative small molecule drug SAL0140, aimed at treating chronic kidney disease (CKD) [3] - SAL0140 is a proprietary aldosterone synthase inhibitor with potential applications in multiple significant chronic disease areas, indicating substantial market potential [3] - Successful development could open new growth avenues for Shenzhen Xinlitai [3] Group 4 - Junshi Biosciences reported a decrease in the shareholding percentage of Greenland Financial Investment Group and its affiliates from 5.0051% to 4.7129% due to share lending [4] - This change is a technical operation rather than an active reduction in holdings, but it brings the shareholding below the 5% disclosure threshold, warranting market attention on future actions [4] Group 5 - Sichuan Sichuang Medical Technology Co., Ltd. announced the resignation of Chairman Xu Yiran to facilitate governance structure optimization, while he will remain a board member [5] - The appointment of Wei Naixu as the new chairman indicates a strategic move to clarify responsibilities and strengthen governance rather than a response to a crisis [5]

Group 1 - Guizhou BaiLing's actual controller Jiang Wei has been investigated by the China Securities Regulatory Commission (CSRC) for insider trading and information disclosure violations, indicating a focus on regulatory enforcement against key individuals [1] - The investigation may exacerbate operational uncertainties for Guizhou BaiLing, which has faced performance pressures in recent years, raising concerns about corporate governance and information disclosure risks [1] Group 2 - Jianyou Co., Ltd. has received ANDA approval from the FDA for its propofol emulsion injection, marking a significant step in the company's internationalization of its formulations [2] - The product, commonly used for sedation during surgeries, has substantial market potential in the U.S., which is expected to contribute to revenue growth for Jianyou [2] Group 3 - Shenzhen Xinlitai Pharmaceutical Co., Ltd. has been granted clinical trial approval for its innovative small molecule drug SAL0140, aimed at treating chronic kidney disease (CKD) [3] - SAL0140, an aldosterone synthase inhibitor, targets multiple significant chronic disease areas, including uncontrolled hypertension and CKD, presenting considerable market potential for the company [3] Group 4 - Junshi Biosciences reported a decrease in the shareholding percentage of Greenland Financial Investment Group and its affiliates from 5.0051% to 4.7129% due to share lending, falling below the 5% disclosure threshold [4] - This change is primarily a technical operation rather than an active reduction in holdings, but the market will need to monitor the future actions of these shareholders [4] Group 5 - Sichuang Medical Technology has elected Wei Naixu as the new chairman following the resignation of Xu Yiran, who stepped down to facilitate governance structure optimization [5] - Xu Yiran will remain on the board, indicating that the adjustment aims to clarify responsibilities and strengthen governance rather than signaling a crisis [5]