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信立泰(002294) - 关于召开2025年第一次临时股东大会的通知
2025-12-09 11:15
证券代码:002294 证券简称:信立泰 编号:2025-066 深圳信立泰药业股份有限公司 关于召开 2025 年第一次临时股东大会的通知 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。 深圳信立泰药业股份有限公司(下称"公司")第六届董事会第十五次会议 于 2025 年 12 月 9 日审议通过《关于提请召开 2025 年第一次临时股东大会的议 案》,现就本次股东大会相关事项通知如下: 一、召开会议的基本情况 公司将通过深交所交易系统和互联网投票系统向全体股东提供网络形式的 投票平台,股东可以在网络投票时间内通过上述系统行使表决权。 公司股东应选择现场投票、网络投票中的一种方式,如果同一表决权出现重 复投票表决的,以第一次有效投票表决结果为准。 (一) 会议届次:2025 年第一次临时股东大会 (二) 会议召集人:公司第六届董事会 公司第六届董事会第十五次会议于 2025 年 12 月 9 日审议通过《关于提请召 开 2025 年第一次临时股东大会的议案》。 (三) 会议召开的合法、合规性:本次股东大会的召开符合有关法律、行 政法规、部门规章、规范性文件、 ...
信立泰(002294) - 第六届监事会第十二次会议决议公告
2025-12-09 11:15
证券代码:002294 证券简称:信立泰 编号:2025-064 深圳信立泰药业股份有限公司 第六届监事会第十二次会议决议公告 与会监事审议并形成如下决议: 一、会议以 3 人同意,0 人反对,0 人弃权,审议通过了《关于取消监事会 及修订〈公司章程〉的议案》。 监事会认为:根据《公司法》、《关于新〈公司法〉配套制度规则实施相关 过渡期安排》、《上市公司章程指引》等有关法律法规、规范性文件的相关规定, 经审核,同意公司不再设置监事会及监事,监事会相关职权由董事会审计委员会 承接,公司《监事会议事规则》相应废止;并同步修订《公司章程》相关条款(章 程最终修订以企业登记机关核准为准)。 本议案尚需提交公司 2025 年第一次临时股东大会审议。 (《关于取消监事会、修订〈公司章程〉的公告》详见信息披露媒体:《中 国证券报》、《证券时报》和巨潮资讯网 www.cninfo.com.cn; 《〈公司章程〉修正案》、《公司章程》详见信息披露媒体:巨潮资讯网 www.cninfo.com.cn。) 备查文件 特此公告 本公司及监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。 深圳信立 ...
信立泰(002294) - 第六届董事会第十五次会议决议公告
2025-12-09 11:15
证券代码:002294 证券简称:信立泰 编号:2025-063 与会董事审议并形成如下决议: 一、会议以 9 人同意,0 人反对,0 人弃权,审议通过了《关于取消监事会 及修订〈公司章程〉的议案》。 为进一步完善公司治理结构,根据《公司法》、《关于新〈公司法〉配套制 度规则实施相关过渡期安排》、《上市公司章程指引》、《深圳证券交易所股票 上市规则》等法律法规、规范性文件的相关规定,结合公司实际情况,公司拟不 再设置监事会及监事,由审计委员会行使《公司法》规定的监事会的职权,公司 《监事会议事规则》相应废止;并同步修订《公司章程》相关条款(章程最终修 订以企业登记机关核准为准)。 本议案尚需提交公司 2025 年第一次临时股东大会审议,董事会提请股东大 会授权公司管理层依法办理相关工商变更登记手续,授权有效期至相关事项全部 办理完毕止。 (《关于取消监事会、修订〈公司章程〉的公告》详见信息披露媒体:《中 国证券报》、《证券时报》和巨潮资讯网 www.cninfo.com.cn; 《〈公司章程〉修正案》、《公司章程》详见信息披露媒体:巨潮资讯网 www.cninfo.com.cn。) 在公司股东大会审议通过取消 ...
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-09 03:14
Group 1 - The company has received clinical trial approval for its innovative small molecule drug SAL0140, aimed at treating primary hyperaldosteronism [1][2] - SAL0140 is a proprietary aldosterone synthase inhibitor, with potential indications including uncontrolled hypertension, primary hyperaldosteronism, and chronic kidney disease (CKD) [1] - The drug is expected to lower aldosterone levels in patients, potentially reducing blood pressure and organ damage, indicating significant development potential [1] Group 2 - The company’s drugs Xinchaotuo and Fulitan have been newly included in the National Medical Insurance Directory, while Ennaero has successfully renewed its inclusion [3][4] - Xinchaotuo is the first approved ARNI co-crystal drug in China, showing significant blood pressure reduction in clinical trials, with a notable average decrease of 25.07 mmHg to 28.22 mmHg after 12 weeks of treatment [7] - Fulitan is a compound formulation that effectively lowers blood pressure while minimizing adverse effects, making it suitable for salt-sensitive and elderly hypertensive patients [7][9] Group 3 - Ennaero is a new generation HIF-PHI drug approved for treating anemia in CKD patients, demonstrating high efficacy and safety [11][12] - The company has established an innovative product matrix in the cardiovascular chronic disease field, focusing on the heart-kidney metabolic syndrome [14] - The new medical insurance directory will be effective from January 1, 2026, and the company aims to enhance drug accessibility and meet unmet clinical needs [14]
信立泰:SAL0140获临床试验批准
Zhi Tong Cai Jing· 2025-12-08 11:15
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140, aimed at treating primary aldosteronism [1] Group 1: Drug Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company [1] - The drug is intended to address indications including uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1]
信立泰(002294.SZ):SAL0140获临床试验批准
智通财经网· 2025-12-08 11:14
Core Viewpoint - The company received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140, aimed at treating primary aldosteronism [1] Group 1: Drug Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company [1] - The drug is intended to target indications including uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1]
信立泰(002294.SZ):SAL0140获得临床试验批准通知书
Ge Long Hui A P P· 2025-12-08 11:11
Core Viewpoint - The company, Xinlitai (002294.SZ), has received approval from the National Medical Products Administration to conduct clinical trials for its innovative small molecule drug SAL0140, aimed at treating primary aldosteronism [1] Group 1: Drug Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company [1] - The drug is intended to target conditions such as uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1] - Aldosterone plays a crucial role in maintaining fluid and electrolyte balance and is involved in various cardiovascular and renal diseases [1] Group 2: Market Potential - Aldosterone synthase inhibitors are expected to lower aldosterone levels in patients with primary aldosteronism, potentially reducing blood pressure and organ damage [1] - The development of SAL0140 presents significant potential in the market due to its targeted therapeutic applications [1]
信立泰:SAL0140片临床试验获批
Xin Lang Cai Jing· 2025-12-08 10:36
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140, aimed at treating primary aldosteronism [1] Group 1: Drug Development - SAL0140 is a self-developed aldosterone synthase inhibitor with independent intellectual property rights [1] - The drug is intended to address indications including uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1]
信立泰(002294) - 关于SAL0140获得临床试验批准通知书的公告
2025-12-08 10:30
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。 证券代码:002294 证券简称:信立泰 编号:2025-062 深圳信立泰药业股份有限公司 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 二〇二五年十二月九日 SAL0140 是 ...
信立泰(002294.SZ):信超妥、复立安、恩那罗等药品纳入国家医保目录
Ge Long Hui A P P· 2025-12-08 09:29
Core Viewpoint - Xinlitai (002294.SZ) has announced that its product, Aliskiren Tablets, has been included in the regular catalog of medical insurance under Category B management, reflecting the company's commitment to enhancing drug accessibility and meeting unmet clinical needs in the cardiovascular chronic disease sector [1] Group 1: Product Inclusion in Medical Insurance - Aliskiren Tablets have been included in the medical insurance catalog under Category B management [1] - Other products such as Rolitin (Aliskiren Amlodipine Tablets) and Xinlitin (Benzyl Acid Faglitin Tablets) have previously been negotiated for inclusion in the medical insurance catalog and are still under valid agreements [1] Group 2: Focus on Chronic Disease Management - The company is focusing on the cardiovascular chronic disease field, particularly on Cardio-Renal Metabolic Syndrome (CKM) [1] - A differentiated product portfolio has been established to address various pathogenesis and patient classification characteristics in hypertension, covering the entire treatment needs from primary hypertension without complications to diseases with cardio-renal target organ damage [1] Group 3: Innovation and Market Strategy - Six new chronic disease drugs have been included in the medical insurance catalog through negotiations, demonstrating national support for innovative drugs with high clinical value [1] - The company aims to leverage policy opportunities to actively promote the inclusion of negotiated drugs in hospitals and market coverage, continuously enhancing drug accessibility based on clinical value [1]