人民财讯9月5日电，信立泰（002294）9月5日晚间公告，近日，公司收到国家药监局核准签发的恩那度 司他片(恩那罗)药品注册证书，其用于治疗透析(包括血液透析和腹膜透析)慢性肾脏病(CKD)患者的贫 血适应症获批。 恩那罗是国内上市的新一代缺氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI)药物，2023年已获批用于非透 析的成人慢性肾脏病(CKD)患者的贫血治疗，并于同年被纳入国家医保目录；此次获批的适应症为治疗 透析CKD患者的贫血(统称"肾性贫血")。 ...

Core Viewpoint - The approval of Enarodustat (恩那度司他片) by the National Medical Products Administration marks a significant advancement in the treatment of anemia in chronic kidney disease (CKD) patients undergoing dialysis, providing a new therapeutic option that addresses unmet clinical needs [1] Company Summary - Xintai (信立泰) has received the drug registration certificate for Enarodustat, a new generation HIF-PHI drug, which selectively targets PHD1 enzyme, leading to a more rational regulation of HIF targets [1] - The drug promotes the production of endogenous EPO (erythropoietin) closer to physiological concentrations, improving iron metabolism trends and effectively increasing hemoglobin (Hb) levels [1] Industry Summary - Enarodustat is characterized by high achievement rates, low exceedance rates in elevation speed, and reduced thrombotic risks, making it a safer option for patients [1] - The drug offers advantages such as once-daily oral administration, good medication adherence, no need for weight adjustment, and low risk of drug interactions [1] - The launch of this new indication will provide a novel treatment choice for more patients with renal anemia, better meeting the clinical demands in this field [1]

Core Viewpoint - The company, Xinlitai (002294.SZ), has received a notice of acceptance from the National Medical Products Administration for its clinical trial application of the innovative small molecule drug SAL0139, which is intended for the treatment of hyperlipidemia [1] Company Summary - The drug SAL0139 is developed by the company and possesses independent intellectual property rights [1] - The application submitted by the company is specifically for conducting clinical trials of SAL0139 for hyperlipidemia treatment [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial application of its innovative small molecule drug SAL0139, which is intended for the treatment of hyperlipidemia [1] Group 1 - The drug SAL0139 is developed by the company and possesses independent intellectual property rights [1] - The application submitted by the company is specifically for conducting clinical trials of SAL0139 for hyperlipidemia treatment [1]

Core Viewpoint - The company has received a notice of acceptance from the National Medical Products Administration for its clinical trial application of the innovative small molecule drug SAL0139, which is intended for the treatment of hyperlipidemia [1] Group 1 - SAL0139 is a small molecule drug developed by the company with independent intellectual property rights [1] - The application submitted is specifically for clinical trials aimed at treating hyperlipidemia, a metabolic disease that can lead to multiple systemic complications if not controlled over time [1] - The company will fulfill its information disclosure obligations regarding subsequent developments as required [1]

证券代码：002294 证券简称：信立泰 编号：2025-048 深圳信立泰药业股份有限公司 关于恩那罗®（恩那度司他片） 新增适应症获得药品注册证书的公告 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 理局核准签发的恩那度司他片（恩那罗®）药品注册证书，其用于治疗透析（包 括血液透析和腹膜透析）慢性肾脏病（CKD）患者的贫血适应症获批。 现就相关信息公告如下： 一、药品基本信息 药品通用名：恩那度司他片 上市许可持有人：深圳信立泰药业股份有限公司 药品批准文号：国药准字 H20233662、国药准字 H20233663、国药准字 H20233664 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准增加适应症，发给药品注册证书。 二、其他相关说明 恩那罗®（恩那度司他片）是国内上市的新一代缺氧诱导因子脯氨酰羟化酶 抑制剂（HIF-PHI）药物，2023 年已获批用于非透析的成人慢性肾脏病（CKD） 患者的贫血治疗，并于同年被纳入国家医保目录；本 ...

证券代码：002294 证券简称：信立泰 编号：2025-047 深圳信立泰药业股份有限公司 关于 SAL0139 药品临床试验申请获得受理的公告 一、药品基本情况 药品名称：SAL0139 片 申请事项：境内生产药品注册临床试验 受理号：CXHL2500942、CXHL2500943 受理说明：根据《中华人民共和国行政许可法》第三十二条的规定，经审查， 决定予以受理。 自受理之日起 60 日内，未收到药审中心否定或质疑意见的，申请人可以按 照提交的方案开展临床试验。 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 理局核准签发的受理通知书，公司自主研发的创新小分子药物 SAL0139 片（项 目代码：SAL0139）临床试验申请获得受理。 现就相关信息公告如下： 特此公告 深圳信立泰药业股份有限公司 董事会 二〇二五年九月六日 SAL0139 是公司具有自主知识产权的小分子药物，公司本次提交的申请为 SAL0139 用于治疗高血脂症的临床试验申请。 二、其他相关情况 高脂血症是一种隐匿性强、 ...

Core Viewpoint - The company is accelerating its plan for a spin-off listing, with a current market value of approximately 60 billion yuan, following strategic acquisitions and internal transformations aimed at enhancing its operational efficiency and market position [3][4]. Group 1: Spin-off and Acquisitions - The subsidiary, Xintai Medical, has gained control of Butler Bio through a combination of voting rights delegation and share exchange, marking a significant step in the company's restructuring efforts [5]. - Xintai Medical's acquisition of Butler Bio includes a phased approach, with a total investment of 55 million yuan for a 70% stake, which is expected to fill product gaps in the neuro-intervention treatment sector [5][6]. - The spin-off of Xintai Medical is part of a long-term strategy initiated by the controlling family after a leadership transition, aiming to solidify the company's market position amid industry challenges [3][8]. Group 2: Financial Performance and Challenges - In the first half of the year, the company reported revenues of 2.131 billion yuan and a net profit of 365 million yuan, reflecting year-on-year growth of 4.32% and 6.1%, respectively [9]. - Despite the growth, the company faces cash flow pressures, with net cash flow from operating activities declining by 20.19% to 425 million yuan, attributed to rising accounts receivable and the impact of halted R&D projects [10][11]. - The company’s reliance on agency sales has increased, with agency sales accounting for 42.3% of revenue in the first half of the year, raising concerns about the effectiveness of this model in a competitive market [11]. Group 3: Strategic Adjustments and Future Outlook - The company has undergone significant internal adjustments, including a shift towards innovative drug development and a focus on chronic disease management, which has led to a recovery in performance and market value [8]. - The introduction of new products, such as the innovative drug Xintai Tan, has positioned the company favorably in the market, although the sustainability of this growth remains to be seen [9][10]. - The company’s high valuation is under scrutiny, especially in light of the competitive landscape and the need for a robust sales strategy to support its innovative pipeline [7][11].

Group 1 - The core viewpoint of the news is that Shenzhen Xinlitai Pharmaceutical Co., Ltd. has seen a stock price increase of 5.11%, reaching 57.21 CNY per share, with a total market capitalization of 63.779 billion CNY [1] - The company was established on November 3, 1998, and went public on September 10, 2009. Its main business involves the research, production, and sales of pharmaceuticals and medical devices [1] - The revenue composition of the company is as follows: formulations account for 81.69%, medical devices 8.54%, raw materials 7.17%, and others 2.59% [1] Group 2 - From the perspective of fund holdings, one fund under Yinhua Fund has a significant position in Xinlitai, holding 5.2574 million shares, which constitutes 2.63% of the fund's net value, ranking it as the eighth largest holding [2] - The fund, named Innovation Medicine (159992), has a total scale of 9.473 billion CNY and has achieved a year-to-date return of 37.91%, ranking 416 out of 4222 in its category [2] - The fund has a one-year return of 56.73%, ranking 1242 out of 3795, but has experienced a loss of 3.98% since its inception [2] Group 3 - The fund managers of Innovation Medicine are Ma Jun and Wang Shuai, with Ma having a tenure of 13 years and 5 days, managing assets totaling 33.304 billion CNY, and achieving a best return of 144.61% during his tenure [3] - Wang Shuai has a tenure of 6 years and 72 days, managing assets of 20.936 billion CNY, with a best return of 76.27% during his tenure [3]

Core Viewpoint - Long-term institutional investors are revealing their positions amidst short-term market fluctuations, indicating a deeper judgment on future market trends by renowned fund managers like Zhang Kun and Ge Lan [2][18]. Group 1: Zhang Kun's Portfolio Adjustments - Zhang Kun's management of the E Fund Blue Chip Select has seen a slight reduction in stock positions, with the stock holding ratio decreasing from 94.14% to 92.63%, marking the lowest level in nearly three years [3]. - The fund's top ten holdings now account for 83.84% of its net value, the highest in the past ten quarters, while the "invisible heavyweights" (ranked 11th to 20th) have significantly decreased from 18.05% to 9.22% [3][4]. - Notable adjustments include a reduction in holdings of Meituan-W by 46.43% and an increase in holdings of Fenzhong Media from 1.53 million shares to 2.48 million shares [4][5]. Group 2: Ge Lan's Focus on Innovative Pharmaceuticals - Ge Lan's management of the China Europe Fund has seen a significant increase in the number of holdings in innovative pharmaceuticals, with the top ten holdings including new entries like Xinli Tai and Bai Li Tian Heng [10][12]. - The fund's turnover rate reached 61.3%, indicating a dynamic adjustment strategy, with a notable increase in the number of innovative drug stocks in the top twenty holdings [10][12]. - Ge Lan emphasizes that the pharmaceutical sector will continue to grow driven by innovation, consumer recovery, and domestic substitution, with a focus on the innovative drug industry chain and consumer healthcare [19][20]. Group 3: Market Sentiment and Future Outlook - Zhang Kun challenges the prevailing pessimistic view on domestic demand, arguing that consumer confidence is influenced by expectations rather than just current economic conditions [18][19]. - Ge Lan anticipates that the pharmaceutical industry will rely on innovation breakthroughs and consumer recovery for growth, despite potential risks from global economic fluctuations [19][20].