深圳信立泰药业股份有限公司 关于 SAL0139 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 SAL0139 片（项目代码：SAL0139）开展治疗高脂血症的临床试验。 高脂血症是一种隐匿性强、危害广泛的代谢性疾病，长期未控制可引发多系 统并发症，低密度脂蛋白胆固醇（LDL-C）相关的高胆固醇积累是导致心脑血管 疾病的关键风险因素。 证券代码：002294 证券简称：信立泰 编号：2025-059 深圳信立泰药业股份有限公司 董事会 二〇二五年十一月二十二日 临床前研究显示，SAL0139 具有降低 LDL-C 的潜力，若能研发成功并获批 上市，将有望为更多患者提供新的用药选择，提高患者依从性，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。 （详见 2025 年 9 月 6 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.c ...

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 SAL0139, aimed at treating hyperlipidemia [1] Group 1 - The drug SAL0139 is a self-developed innovative small molecule medication [1] - The approval allows the company to commence clinical trials for the treatment of hyperlipidemia [1]

Core Viewpoint - The company, Xinlitai, has received approval from the National Medical Products Administration for its innovative small molecule drug SAL0139 tablets to conduct clinical trials for the treatment of hyperlipidemia [1] Group 1 - The drug SAL0139 is developed independently by the company [1] - The clinical trial approval is a significant step towards the drug's potential market entry [1] - The company will conduct the clinical trials in accordance with national drug registration regulations and requirements [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0139 for treating hyperlipidemia, indicating potential growth in its chronic disease product pipeline [1] Group 1: Clinical Trial Approval - The company announced that it has obtained a Clinical Trial Approval Notice for SAL0139 from the National Medical Products Administration [1] - The drug has shown potential in lowering LDL-C during preclinical studies [1] Group 2: Product Pipeline and Market Impact - Successful development and approval of SAL0139 would enhance the company's innovative product pipeline in the chronic disease sector [1] - The long drug development cycle and high risks associated with pharmaceutical research mean that there is uncertainty from clinical trials to market approval, with no immediate impact on short-term performance [1]

Core Viewpoint - The company, Xinlitai, has received approval from the National Medical Products Administration for clinical trials of its innovative small molecule drug SAL0139 for the treatment of hyperlipidemia [1] Group 1 - The clinical trial approval notification was issued on November 21 [1] - SAL0139 is identified by the project code SAL0139 [1] - The drug is aimed at treating hyperlipidemia, a condition characterized by high levels of lipids in the blood [1]

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 SAL0139, aimed at treating hyperlipidemia [1] Group 1: Company Developments - Xinlitai has been granted a Clinical Trial Approval Notice for SAL0139, which is a self-developed drug targeting hyperlipidemia [1] - The drug SAL0139 has shown potential in preclinical studies to lower low-density lipoprotein cholesterol (LDL-C), a key risk factor for cardiovascular diseases [1] Group 2: Industry Context - Hyperlipidemia is a significant metabolic disease that can lead to various complications if not controlled, with LDL-C accumulation being a critical risk factor for cardiovascular diseases [1] - The successful development and approval of SAL0139 could provide new treatment options for patients, enhance patient compliance, and address unmet clinical needs in the chronic disease sector [1]

智通财经APP讯，信立泰(002294.SZ)发布公告，近日，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SAL0139片(项目代码：SAL0139)开展治疗高 脂血症的临床试验。 临床前研究显示，SAL0139具有降低LDL-C的潜力，若能研发成功并获批上市，将有望为更多患者提供 新的用药选择，提高患者依从性，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。 高脂血症是一种隐匿性强、危害广泛的代谢性疾病，长期未控制可引发多系统并发症，低密度脂蛋白胆 固醇(LDL-C)相关的高胆固醇积累是导致心脑血管疾病的关键风险因素。 ...

（文章来源：每日经济新闻） 每经AI快讯，11月21日，信立泰(002294.SZ)公告称，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SAL0139片开展治疗高脂血症的临床试验。 SAL0139具有降低LDL-C的潜力，若能研发成功并获批上市，将有望为更多患者提供新的用药选择。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。 ...

Group 1 - The core viewpoint indicates a decline in innovative drug concept stocks, with notable drops in companies such as Kanglong Chemical, Kelun Pharmaceutical, and Xinlitai, among others [1] - The innovative drug-related ETFs have also experienced a decline, with an overall drop exceeding 2% [1] - Despite the downturn, there have been positive developments in China's biotechnology sector, including 35 research presentations at the ESMO 2025 conference and significant collaborations like the $11.4 billion partnership between Innovent Biologics and Takeda, highlighting global recognition of Chinese innovative drug value [2]

Core Insights - The seventh Guangdong-Hong Kong-Macao Greater Bay Area Biopharmaceutical Innovation Conference was held in Guangzhou, focusing on the development paths of innovative drugs and the role of AI in drug research and development [1][2] - Industry experts emphasized the need for Chinese pharmaceutical companies to shift from "follower" to "leader" by addressing unmet medical needs and leveraging innovative technologies [1][2] Group 1: Conference Highlights - The conference theme was "Bay Area Innovation, Navigating New Journeys," discussing key topics such as dual circulation development, accelerated technology transfer, and compliance in global expansion [1] - Notable speakers included industry leaders and experts, highlighting the importance of innovation and internationalization as core drivers for Chinese pharmaceutical companies [2] Group 2: Regulatory and Industry Perspectives - The Director of the Guangdong Provincial Drug Administration stressed the importance of drug quality and safety, urging companies to strengthen regulatory compliance and communication with authorities to avoid approval delays [1] - The conference aimed to inject new vitality into the biopharmaceutical industry in the Greater Bay Area and across China, promoting high-quality development and attracting talent and projects [1]