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信立泰(002294) - 关于信超妥、复立安、恩那罗等药品纳入国家医保目录的公告
2025-12-08 09:15
具体情况如下: 一、药品情况 (一) 信超妥 1、 基本情况 药品名称:沙库巴曲阿利沙坦钙片 医保类别:乙类 证券代码:002294 证券简称:信立泰 编号:2025-061 深圳信立泰药业股份有限公司 关于信超妥、复立安® 、恩那罗®等药品 纳入国家医保目录的公告 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。 根据国家医保局、人力资源社会保障部发布的《关于印发〈国家基本医疗保 险、生育保险和工伤保险药品目录〉以及〈商业健康保险创新药品目录〉(2025 年)的通知》(医保发〔2025〕33 号)(下称"《通知》"),深圳信立泰药 业股份有限公司(下称"公司")的药品信超妥(沙库巴曲阿利沙坦钙片)、复 立安®(阿利沙坦酯吲达帕胺缓释片),通过谈判新纳入《国家基本医疗保险、 生育保险和工伤保险药品目录(2025 年)》(下称"医保目录")乙类范围, 恩那罗®(恩那度司他片)续约成功保留在医保目录内;信立坦(阿利沙坦酯片) 调整至医保常规目录管理。 备注:限原发性高血压。 协议有效期:2026 年 1 月 1 日至 2027 年 12 月 31 日。 信超妥本次为 ...
12月4日生物经济(970038)指数跌0.2%,成份股华兰疫苗(301207)领跌
Sou Hu Cai Jing· 2025-12-04 10:36
证券之星消息,12月4日,生物经济(970038)指数报收于2117.66点,跌0.2%,成交104.77亿元,换手 率0.98%。当日该指数成份股中,上涨的有17家,信立泰以3.4%的涨幅领涨,下跌的有33家,华兰疫苗 以5.75%的跌幅领跌。 近10日内生物经济(970038)指数成份股做了调整,新纳入了9只股票,剔除了9只股票。 资金流向方面,生物经济(970038)指数成份股当日主力资金净流出合计4.59亿元,游资资金净流入合 计3157.72万元,散户资金净流入合计4.28亿元。成份股资金流向详情见下表: | 代码 | 名称 | 主力净流入(元) | 主力净占比 游资净流入 (元) | | 游资净占比 散户净流入(元) | | 散户净占比 | | --- | --- | --- | --- | --- | --- | --- | --- | | 300026 红日药业 | | 3806.67万 | 7.20% | 2160.87万 | 4.09% | -5967.54万 | -11.29% | | 002019 亿帆医药 | | 2587.00万 | 11.47% | -274.72万 | -1.2 ...
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
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") ...
信立泰创新药获批!港股通创新药ETF(159570)四连跌后反弹1.5%,近5日净流入超1.8亿!2026年展望:首版商保创新药目录落地在即!
Xin Lang Cai Jing· 2025-12-04 03:54
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 ...
贵州百灵实控人被证监会立案;健友股份丙泊酚乳状注射液获FDA批准
Mei Ri Jing Ji Xin Wen· 2025-12-03 23:21
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]
贵州百灵实控人被证监会立案;健友股份丙泊酚乳状注射液获FDA批准|医药早参
Mei Ri Jing Ji Xin Wen· 2025-12-03 23:12
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]
信立泰(002294.SZ):创新小分子药物SAL0140片获得临床试验批准
智通财经网· 2025-12-03 10:44
Core Viewpoint - The company, Xinlitai (002294.SZ), has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140, aimed at treating chronic kidney disease (CKD) [1] Group 1: Drug Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company, targeting conditions such as uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1] - The drug is expected to mitigate end-organ damage through the inhibition of aldosterone synthesis, potentially improving the progression of chronic kidney disease [1] Group 2: Mechanism of Action - Aldosterone is a crucial mineralocorticoid hormone that maintains fluid and electrolyte balance by activating mineralocorticoid receptors (MR), and it is directly involved in various cardiovascular and renal diseases [1] - Aldosterone synthase inhibitors may offer therapeutic benefits by reducing both genomic and non-genomic effects associated with end-organ damage [1]
信立泰:创新小分子药物SAL0140片获得临床试验批准
Zhi Tong Cai Jing· 2025-12-03 10:36
Core Viewpoint - The company, Xinlitai (002294.SZ), has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140, aimed at treating chronic kidney disease (CKD) [1] Group 1: Drug Development - SAL0140 is a proprietary aldosterone synthase inhibitor developed by the company, targeting indications such as uncontrolled hypertension (including resistant hypertension), primary aldosteronism, and chronic kidney disease (CKD) [1] - The drug aims to inhibit the synthesis of aldosterone, which is crucial for maintaining fluid and electrolyte balance, and is involved in various cardiovascular and renal diseases [1] Group 2: Mechanism of Action - Aldosterone is the most important mineralocorticoid hormone in the human body, activating mineralocorticoid receptors (MR) to regulate fluid and electrolyte balance [1] - Aldosterone synthase inhibitors are expected to mitigate end-organ damage caused by both genomic and non-genomic effects, potentially improving the progression of chronic kidney disease [1]
信立泰SAL0140获临床试验批准通知书
Bei Jing Shang Bao· 2025-12-03 10:17
Core Viewpoint - Recently, the company received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0140 for the treatment of chronic kidney disease (CKD) [1] Group 1: Company Developments - The company announced that SAL0140 is a proprietary aldosterone synthase inhibitor [1] - The drug is intended to target indications including uncontrolled hypertension (including resistant hypertension), primary hyperaldosteronism, 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
2025-12-03 10:15
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抑制醛固酮的合成,减轻基因组和非基因组效应下的终 末器官损伤,具有改善慢性肾病进展的潜力。 证券代码:002294 证券简称:信立泰 编号:2025-060 深圳信立泰药业股份有限公司 获得临床试验批准通知书的公告 (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》) 关于 SAL0140 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:S ...