证券代码：002294 证券简称：信立泰 编号：2025-035 深圳信立泰药业股份有限公司 关于阿利沙坦酯吲达帕胺缓释片（复立安®） 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 理局核准签发的阿利沙坦酯吲达帕胺缓释片（复立安®）药品注册证书。现就相 关信息公告如下： 一、药品基本信息 药品通用名：阿利沙坦酯吲达帕胺缓释片 剂型：片剂 规格：每片含阿利沙坦酯 240mg 与吲达帕胺 1.5mg 适应症：原发性高血压 注册分类：化学药品 2.3 类 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 H20250028 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，批准注册，发给药品注册证书。 二〇二五年六月五日 二、其他相关说明 阿利沙坦酯吲达帕胺缓释片（复立安®）用于治疗原发性高血压。复立安®为 国产原研 ARB/利尿剂类复方缓释制剂（项目代码：SAL0108），阿利沙坦酯和 吲达帕胺两药联用，可以降低 ...

Core Viewpoint - The company, Xinlitai (002294), has received approval from the National Medical Products Administration for the registration of Aliskiren Indapamide Sustained-Release Tablets (Fuli'an), which are intended for the treatment of primary hypertension [1] Group 1: Product Details - The new drug contains 240mg of Aliskiren and 1.5mg of Indapamide per tablet [1] - Fuli'an is a domestically developed compound sustained-release formulation combining ARB and diuretics [1] Group 2: Strategic Positioning - The introduction of Fuli'an complements existing products such as Xinlitai, Xinchao, and Fulitai, enhancing the company's competitive edge in the cardiovascular chronic disease treatment sector [1] - The product aims to meet a broader range of clinical needs, thereby strengthening the company's market position [1]

Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical industry, specifically for pharmaceutical manufacturing and pharmaceutical services [1][2]. Core Insights - Continuous attention is recommended for innovative drugs with rising prosperity, as evidenced by the record number of 73 oral reports on Chinese innovative drug assets at the 2025 ASCO annual meeting [2][36]. - The Chinese innovative drug sector is experiencing a significant demand from multinational corporations (MNCs), which is reflected in the increasing number of overseas business development (BD) transactions [36]. - The pharmaceutical sector outperformed the market in May 2025, with the SW Pharmaceutical and Biological sector rising by 6.4%, ranking first among Shenwan's primary industries [15][37]. Summary by Sections Investment Highlights - The report highlights a portfolio of A-Shares including Jiangsu Heng Rui Medicine, Huadong Medicine, Sichuan Kelun Pharmaceutical, and others, indicating a focus on companies with strong growth potential [2][5]. - The report notes that the pharmaceutical sector's premium level relative to all A-Shares is currently at a normal level, with a relative premium rate of 87.88% as of the end of May 2025 [28][37]. Performance Analysis - In May 2025, the pharmaceutical sector's performance was ranked first, with individual stock gains led by Staidson Beijing BioPharmaceuticals (+145.4%) and Sunshine Guojian Pharmaceutical (+99.4%) [15][37]. - The report also details the performance of the Hong Kong and U.S. pharmaceutical sectors, noting that the Hong Kong stock pharmaceutical sector outperformed the market while the U.S. sector underperformed [38]. Market Trends - The report emphasizes the upward trend in the innovative drug market, with traditional pharmaceutical companies emerging from centralized procurement challenges and entering a phase of profitability [36]. - The report indicates that the biopharmaceutical sector's sub-sectors, such as chemical raw materials and biological products, have shown strong performance, with increases of 10.5% and 7.3% respectively [20][37].

Core Viewpoint - The article discusses the performance and holdings of the ICBC Frontier Medical Stock C fund, highlighting its recent growth and ranking among similar funds [1]. Fund Performance - The latest net value of ICBC Frontier Medical Stock C is 2.9850 yuan, reflecting a growth of 3.36% [1]. - The fund's return over the past month is 5.06%, ranking 72 out of 1022 similar funds [1]. - Over the last three months, the return is 10.06%, with a ranking of 63 out of 1009 [1]. - Year-to-date, the fund has achieved a return of 12.46%, ranking 107 out of 999 [1]. Fund Holdings - The top ten holdings of ICBC Frontier Medical Stock C account for a total of 59.05% of the fund, with the following key positions: - Heng Rui Medicine: 10.11% - Kelun Pharmaceutical: 8.01% - WuXi AppTec: 7.72% - BeiGene: 6.85% - Xinlitai: 4.90% - Zai Lab: 4.77% - Yuyue Medical: 4.60% - New Horizon: 4.36% - East China Pharmaceutical: 4.20% - Haizhi Pharmaceutical: 3.53% [1]. Fund Background - ICBC Frontier Medical Stock C was established on November 23, 2020, and as of March 31, 2025, it has a total scale of 1.38 billion yuan [1]. - The fund manager is Zhao Bei, who has extensive experience in the healthcare sector [2].

GW906是国为医药自主研发的靶向血管紧张素原(Angiotensinogen,AGT)的小干扰核糖核酸(siRNA)药 物，拟开发的适应症为原发性高血压，目前正在开展1期临床研究。GW906通过间歇性皮下注射，以实 现长期、稳定的降压效果，进而提高患者依从性。临床前数据显示，GW906的疗效和安全性表现优 异。 信立泰为什么愿意斥资5.5亿元押注？资料显示，该公司是我国高血压仿制药龙头，而高血压属于慢性 病，需求长期稳定增长。但近年来受集采压制，增速几乎停滞。信立泰于2019年选择向创新药转型，6 年来投入大量研发资金，进行研发管线布局，2025年一些项目陆续进入验收成果期，这其中就包括高血 压赛道药品。 就在5月27日，信立泰发布公告称，其高血压新药信超妥(沙库巴曲阿利沙坦钙片，S086)获得国家药品 监督管理局的上市批准。资料显示，信超妥是信立泰自主研发的ARNI(血管紧张素受体脑啡肽酶抑制 剂)类药物，本次获批的适应证为原发性高血压。信超妥是我国原研第一款、全球第二款获批的ARNI类 药物，化合物专利保护期至2037年。该药品不仅能降压，还有抗心衰和心、肾双保护的作用。 5月29日，信立泰（00229 ...

Core Viewpoint - The innovative pharmaceutical industry in China is experiencing a "triple resonance" of policy support, industry upgrades, and performance recovery, leading to a restructuring of capital market valuation logic [1] Group 1: Business Development (BD) Collaborations - In May 2025, China’s pharmaceutical industry saw significant BD announcements, including a $60.5 billion collaboration between 3SBio and Pfizer for the SSGJ-707 project [2] - Following this, Sinopharm announced a licensing agreement with Chengdu Guowei Biopharmaceutical for the AGT-siRNA drug GW906, with potential payments totaling up to 5.5 billion yuan [3] - The collaboration between Sinopharm and Guowei aims to enhance the company's pipeline in chronic disease treatment, particularly for primary hypertension [3] Group 2: Market Trends and Innovations - The siRNA technology is highlighted as a frontier in global innovative drug development, with companies like Alnylam leading the market [3][4] - The small nucleic acid market is driven by increasing penetration of existing drugs and unique advantages over traditional small molecules and monoclonal antibodies [5][6] - The success rate of siRNA drugs from project initiation to clinical phase III is approximately 60%, significantly higher than traditional drugs [6] Group 3: Valuation and Market Dynamics - The valuation logic for innovative drugs is evolving, focusing on "technology scarcity × market space × threat of alternative therapies" [7] - The average R&D cost for Chinese innovative drugs is 40%-60% lower than that of Western counterparts, with a reduced timeline from IND to BLA of 1.8 years [8] - In 2024, 228 BD transactions were recorded, with a 36% increase from 2023, indicating a growing trend in domestic and international collaborations [9] Group 4: Strategic Partnerships and Challenges - Large multinational companies are increasingly engaging in early-stage Chinese innovation projects, recognizing the potential for cost-effective assets and market opportunities [10] - The challenges in BD collaborations often stem from valuation discrepancies, with domestic firms focusing on R&D potential while foreign firms prioritize market size and regulatory predictability [10] - Companies are advised to enhance their core value and innovation capabilities while also focusing on intellectual property protection to navigate the complexities of international markets [11][12] Group 5: Future Outlook - The transformation of Chinese innovative pharmaceutical companies from "price takers" to "rule makers" is underway, emphasizing the importance of continuous technological innovation and rational value recognition [13]

Group 1 - Guangdian Electric's wholly-owned subsidiary plans to sell 5.91% stake in Shanghai Winshun Electric Technology Co., Ltd. to Yapp Automotive Parts Co., Ltd. for 62.63 million yuan, aiming to optimize asset structure [1] - Anhui Natural Gas received approval for the registration of 500 million yuan short-term financing bonds and 600 million yuan medium-term notes, valid for two years [1] - Kirin Security received government subsidies totaling 6.48 million yuan, which are related to revenue [2] Group 2 - Junshi Biosciences received approval for two new indications for its self-developed drug, Oncorhynchus monoclonal antibody injection, targeting adult patients with heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia [3] - China Resources Double Crane's subsidiary passed GMP compliance inspection for small and large volume injection production lines [4] - Nanjing Public Utilities' board approved the absorption and merger of its wholly-owned subsidiary, Nanjing Jinguang Industry Co., Ltd. [7] Group 3 - Boya Bio received drug registration certificate for human immunoglobulin (pH4) in the Dominican Republic, valid until August 12, 2029 [8] - Jizhi Co. announced that its controlling shareholder and actual controller committed not to reduce their shareholdings until December 31, 2025 [9] - Yuhua Tian won a bid for the integrated urban management project in Lanzhou City, with a total service subsidy of 353 million yuan [10] Group 4 - Anke Rui obtained five invention patent certificates related to various energy management and control technologies [11] - Kebo Da's wholly-owned subsidiary plans to acquire 100% of Czech IMI Company for approximately 9.43 million euros to enhance global production layout [13] - Yantian Port announced a cash dividend of 1.30 yuan per 10 shares, totaling 676 million yuan [14] Group 5 - Huawang Technology plans to distribute a cash dividend of 0.45 yuan per share and a capital reserve increase of 0.20 shares per share [15] - Kabe Yi established a wholly-owned subsidiary in Japan to enhance its business layout [16] - Dongcheng Pharmaceutical's subsidiary received approval for the marketing of sodium fluoride injection, a PET radiopharmaceutical [18] Group 6 - Huaxin New Materials' subsidiary received two utility model patent certificates for innovative devices [19] - Lingang Steel's new 2290 cubic meter blast furnace has been successfully put into operation [21] - Xinlitai received drug registration certificate for Sacubitril/Valsartan tablets, the first of its kind in China [23] Group 7 - Aike Co.'s subsidiary received project designation notices from multiple clients for electric drive platform components [25] - Tonghe Pharmaceutical received drug registration certificate for Apixaban in South Korea [26] - Junting Hotel signed a cooperation agreement with Choice Hotels for exclusive brand usage in mainland China [28] Group 8 - Guangdong Hongtu plans to establish a wholly-owned subsidiary in Zhengzhou to enhance market layout [30] - Yuheng Pharmaceutical signed a joint promotion agreement for Pemafibrate tablets with Xinghe Pharmaceutical [31] - Chongqing Steel terminated the absorption and merger of its wholly-owned subsidiary, citing strategic advantages of independent operation [33] Group 9 - Jihong Co. announced the listing of its H-shares on the Hong Kong Stock Exchange [34] - Deshi Co. announced plans for shareholders to reduce their holdings by up to 0.3% [36] - Xinhai Medical's subsidiary received medical device registration for a dialysis fluid filter [42]

药品通用名：沙库巴曲阿利沙坦钙片 商品名：信超妥 证券代码：002294 证券简称：信立泰 编号：2025-034 深圳信立泰药业股份有限公司 关于沙库巴曲阿利沙坦钙片（信超妥） 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 理局核准签发的沙库巴曲阿利沙坦钙片（信超妥）药品注册证书，现就相关信息 公告如下： 一、药品基本信息 二、其他相关说明 沙库巴曲阿利沙坦钙片（信超妥）为公司独家研发的新药，本次获批的适应 症为原发性高血压。 剂型：片剂 规格：120mg、240mg 适应症：原发性高血压 注册分类：化学药品 2.1 类 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 H20250017、国药准字 H20250018 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，批准注册，发给药品注册证书。 特此公告 深圳信立泰药业股份有限公司 董事会 二〇二五年五月二十八日 信超妥是我国原研第一款、全球第二款获批的 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for its newly developed drug, Sacubitril/Valsartan Calcium Tablets (Xinchao Tuo), which is indicated for primary hypertension and represents a significant advancement in the ARNI class of medications [1] Group 1: Drug Approval and Characteristics - The drug is the first original research product in China and the second globally approved ARNI medication, with a compound patent protection period extending until 2037 [1] - Phase III clinical trial results indicate significant antihypertensive efficacy with a clear dose-dependent response [1] Group 2: Strategic Positioning - Following the launch of Xinchao Tuo, the company will enhance its competitive position in the cardiovascular chronic disease treatment sector by complementing its existing products, Xintan and Fulitan, to meet a broader range of clinical needs [1]

Group 1 - The core viewpoint is that the innovative drug sector is experiencing a positive market response, with significant gains in related indices and ETFs, driven by optimism surrounding upcoming international conferences and research outcomes [1][2][3] - The 国证港股通创新药指数 saw a peak increase of 4.24%, while the 港股创新药ETF reached a peak increase of 3.89%, indicating strong investor interest [1] - Major domestic innovative drug companies, including 恒瑞医药, 信立泰, and 中国生物制药, have multiple research results selected for presentation at the upcoming ASCO annual meeting, highlighting the sector's growth potential [1][2] Group 2 - The optimization of centralized procurement policies is expected to benefit the supply and market competition of generic drugs, enhancing industry efficiency [2] - The upcoming 2025 medical insurance negotiations and adjustments to the Class B catalog are anticipated to shorten the R&D return cycle for companies, supporting the development of innovative drugs [2] - The innovative drug sector is receiving policy support, with an expected increase in success rates for medical insurance negotiations and potential for commercial insurance payment expansion [2][3] Group 3 - The pharmaceutical sector is seeing strong performance in innovative drugs, medical infrastructure, and pharmacies, with a focus on market pricing power and funding changes [3] - Domestic biotech companies are leading globally in areas such as dual-antibody ADCs, indicating a competitive edge in the innovative drug space [3] - The raw material drug industry is benefiting from patent expirations and improved demand, with a focus on companies expanding into formulations and CDMO [3]