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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
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:信超妥等药品被新纳入国家医保目录
转自:证券时报 人民财讯12月8日电,信立泰(002294)12月8日公告,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。复立坦®(阿利沙坦酯氨氯地平片)、信立 汀(苯甲酸福格列汀片)前期已通过谈判纳入医保目录,尚在协议有效期内,属于医保乙类范围。 ...
从慢病药到肿瘤药,为何越来越多新药首发开始选择线上渠道?
Di Yi Cai Jing· 2025-08-21 10:40
Core Insights - The approval pace of new drugs in China has significantly accelerated, with online platforms becoming crucial for patients to purchase new medications, reducing time and effort in finding drugs [1][4] - JD Health has strategically positioned itself as a leading platform for the online launch of new specialty drugs, resulting in substantial performance gains [1][3] Group 1: Financial Performance - JD Health reported total revenue of 35.3 billion RMB for the first half of 2025, marking a year-on-year growth of 24.5% [1] - The number of annual active users on JD Health's platform exceeded 200 million as of June 30, 2025 [1] Group 2: New Drug Launches - Over 30 new drugs were launched on JD Health's platform in the first half of this year, enhancing the integration of online and offline services [2] - The exclusive online launch of the new insomnia drug from Eisai China on JD Health exemplifies the platform's capability to reach core patient groups effectively [3][7] Group 3: Strategic Collaborations - JD Health signed a strategic cooperation agreement with Eisai China to enhance the ecosystem for sleep disorders, leveraging both parties' strengths in drug development and digital health services [3][4] - The collaboration with Novo Nordisk aims to create a comprehensive diagnostic and treatment service model for obesity and diabetes [6] Group 4: Market Trends - The trend of launching new drugs online is driven by the need to shorten market education costs and improve drug accessibility, especially in underserved areas [4] - The demand for weight management drugs has surged, with JD Health serving as a key sales channel for innovative local drugs [5][8] Group 5: Consumer Health Experience - JD Health is responding to the growing demand for personalized health solutions, launching various medical devices and nutritional supplements on its platform [8][9] - The market for nutritional health products is becoming increasingly segmented, with a focus on ready-to-eat products and specific health needs [9] Group 6: Digital Transformation - The online launch of new drugs is seen as a catalyst for activating a new digital healthcare ecosystem in China, accelerating the digital transformation of domestic and international pharmaceutical companies [9]
信立泰: 2025年半年度报告
Zheng Quan Zhi Xing· 2025-08-19 16:34
Core Viewpoint - Shenzhen Salubris Pharmaceuticals Co., Ltd. reported a revenue of approximately 2.13 billion yuan for the first half of 2025, reflecting a year-on-year growth of 4.32% and a net profit attributable to shareholders of approximately 365 million yuan, up 6.10% from the previous year [4][17]. Company Overview and Financial Indicators - The company focuses on the research, development, production, and sales of pharmaceuticals and medical devices, with a strong emphasis on cardiovascular drugs and medical devices [3][4]. - The company plans not to distribute cash dividends or issue bonus shares [1]. - The total assets at the end of the reporting period were approximately 10.63 billion yuan, an increase of 1.55% compared to the previous year [3]. Business Operations - The company has established a diverse product portfolio in the hypertension sector, including products like Xinlitai (ARB class), Xinchao (ARNI class), and Fuli (ARB/CCB combination) [5][6]. - The company achieved a significant increase in sales of its products, with a notable growth in the medical device segment, which saw a revenue increase of 32.54% [7][18]. - The company is actively involved in the development of innovative drugs and medical devices, with a focus on chronic diseases such as hypertension, chronic kidney disease, and metabolic disorders [8][12]. Research and Development - The company invested approximately 542 million yuan in R&D, accounting for 25.43% of its revenue [7][17]. - The company has a robust pipeline with 118 ongoing projects, including 74 chemical drugs and 24 biological drugs [9][10]. - The company submitted four IND applications and received two clinical trial approvals during the reporting period [9]. Market Position and Competitive Advantage - The company has built a strong brand image and market position in the cardiovascular field through its innovative products and evidence-based medical promotion strategies [11][12]. - The company maintains a high standard of quality control and has established a comprehensive supply chain management system to ensure product quality and cost-effectiveness [15][16].