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 ...

目前，公司已有6款慢病新药通过谈判被纳入医保目录，体现了国家对临床价值高的创新药品的支持和 认可。公司将依托政策机遇，积极推进谈判药品入院及市场覆盖，以临床价值为导向，持续提升药物可 及性，满足不同患者群体未被满足的临床需求。 格隆汇12月8日丨信立泰(002294.SZ)公布，信立坦（阿利沙坦酯片）本次已被列入医保药品常规目录乙 类范围管理。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。 在心血管慢病领域，聚焦心肾代谢综合征（CKM），公司已建立起创新产品矩阵，尤其在高血压疾病 领域，针对不同发病机制及患者分型特点，公司构建了差异化产品组合，通过单药、复方至新机制药物 的多层次产品体系，以期覆盖从无合并症的原发性高血压到合并心肾等靶器官损害疾病的全病程治疗需 求。 ...

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。 ...

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].

Group 1 - The new hypertension treatment drug, Xinchaotuo® (Sacubitril/Alesartan Calcium Tablets), has been launched online by JD Health and is the first original ARNI (Angiotensin Receptor Neprilysin Inhibitor) antihypertensive drug developed in China, offering superior and safer blood pressure control [2] - Xinchaotuo® is the first ARNI drug developed in China and the second ARNI co-crystal drug globally, featuring a design that synchronizes the peak effects of its active metabolite, Sacubitril, and Alesartan, thereby extending the half-life of Alesartan and improving blood pressure control [2] - ARNI drugs not only provide effective blood pressure reduction but also offer heart and kidney protection, making them particularly suitable for patients with hypertension combined with heart failure or chronic kidney disease [2] Group 2 - Xinli Tai Pharmaceutical has strategically focused on the hypertension treatment area, developing a complete family of original Alesartan antihypertensive drugs, including single-agent and combination formulations [3] - JD Health aims to leverage its capabilities to help Xinchaotuo® reach a broader patient base, enhancing the treatment level for hypertension in China through this collaboration [3] - JD Health has been recognized as the "first station for the online launch of new specialty drugs," continuously expanding its value effect and providing innovative drug access to a wide range of patients [3]

Group 1 - The overall industry sentiment shows an upward trend in sectors such as machinery, electronics, textiles, real estate, and retail, while coal, oil and petrochemicals, power equipment, food and beverage, pharmaceuticals, home appliances, automotive, banking, public utilities, and environmental protection are on a downward trend [2][21] - The report predicts strong performance in specific sub-industries over the next four weeks, highlighting sectors like general equipment, semiconductors, medical devices, medical services, glass and fiberglass, packaging and printing, cement, decoration, personal care products, real estate services, refining and trading, textile manufacturing, and electricity [2][22] - The investment strategy focuses on three main directions: breakthroughs in technology AI+, valuation recovery in consumer stocks, and the rise of undervalued dividend assets [2][24] Group 2 - The construction materials sector is expected to benefit from urban renewal policies, with support for underground pipeline and facility construction projects, favoring leading companies like Weixing New Materials [3][38] - Cement production is facing a rise in kiln shutdown rates, particularly in northern provinces, with price increases observed in Hubei despite a general downward trend [3][38] - The report recommends a focus on companies such as China National Materials, Weixing New Materials, and others in the construction materials sector [3][39] Group 3 - The report indicates that the relaxation of fiscal discipline in the U.S. and reduced tariffs between China and the U.S. have led to a recovery in global risk appetite, with U.S. stock indices showing gains [4][21] - The report emphasizes the importance of AI in driving growth, with major tech companies shifting focus from model capabilities to product experiences and development tools [6][21] - Investment opportunities in AI-related companies are highlighted, including Xiaomi, Alibaba, Tencent, Kuaishou, and Meituan [6][21] Group 4 - The pharmaceutical company Xinlitai is projected to achieve revenue of 4.012 billion yuan in 2024, a year-on-year increase of 19.22%, with a net profit of 602 million yuan, reflecting steady growth [9][34] - The company is focusing on optimizing its revenue structure through innovative products, with significant growth in its proprietary product sales [9][35] - The report anticipates revenue growth for Xinlitai from 4.538 billion yuan in 2025 to 6.246 billion yuan in 2027, maintaining a "buy" rating despite competitive pressures [9][37] Group 5 - Miniso's Q1 2025 revenue reached 4.43 billion yuan, a year-on-year increase of 19%, with a focus on expanding its store network and enhancing its product offerings [14][30] - The company is implementing a channel upgrade strategy to improve store performance and is actively expanding its overseas presence [14][31] - The report projects adjusted net profits for Miniso to be 2.9 billion yuan in 2025 and 3.6 billion yuan in 2026, maintaining a "buy" rating [14][32]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative return of over 20% within the next six months [7][17]. Core Insights - The company achieved a revenue of 4.01 billion yuan in 2024, representing a year-on-year growth of 19.22%, while the net profit attributable to shareholders was 601.57 million yuan, up 3.71% year-on-year [1]. - In Q1 2025, the company reported a revenue of 1.06 billion yuan, a slight decline of 2.64% year-on-year, with a net profit of 200 million yuan, showing a marginal increase of 0.03% [1]. - The sales expense ratio increased to 36.71% in 2024, primarily due to higher promotional costs for newly launched products [2]. - The company is focusing on optimizing its revenue structure, with a notable increase in the proportion of patented and new products, which are expected to drive future growth [3]. Financial Performance - The company’s revenue for 2025 is projected to be 4.54 billion yuan, with a growth rate of 13.10%, and net profit is expected to be 661.81 million yuan, reflecting a growth rate of 10.01% [5][11]. - The R&D investment for 2024 was 1.02 billion yuan, accounting for 25.35% of revenue, indicating a strong commitment to innovation [4]. - The company’s EBITDA for 2024 is estimated at 1.73 billion yuan, with a net profit margin of 14.99% [11][12]. Product and Pipeline Development - The company has four projects in the NDA stage and three in Phase III clinical trials, showcasing a robust pipeline for future growth [4]. - New products such as复立坦 and 信立汀他 have entered the national medical insurance catalog, laying a foundation for future sales growth [3]. Market Position and Strategy - The company is increasing its market presence through enhanced sales efforts and product promotion, particularly in the competitive hypertension medication market [3][4]. - The revenue from formulations reached 3.19 billion yuan in 2024, up 20.43%, while raw materials and intermediates saw a slight decline [3].

Investment Rating - The report maintains a "Buy" rating for the company [5][7]. Core Views - The company achieved a revenue of 4.012 billion yuan in 2024, representing a year-on-year growth of 19.22%, while the net profit attributable to the parent company was 601.57 million yuan, up 3.71% year-on-year [1]. - In Q1 2025, the company reported a revenue of 1.062 billion yuan, a slight decline of 2.64% year-on-year, with a net profit of 200 million yuan, showing a marginal increase of 0.03% [1]. - The sales expense ratio increased to 36.71% in 2024, primarily due to higher promotional costs for newly launched products [2]. - The revenue structure is shifting towards patented and new products, with a notable increase in the revenue scale of these segments [3]. - The company invested 1.017 billion yuan in R&D in 2024, accounting for 25.35% of its revenue, indicating a strong commitment to innovation [4]. Financial Performance - The projected revenues for 2025, 2026, and 2027 are 4.538 billion, 5.423 billion, and 6.246 billion yuan, respectively, with net profits adjusted to 662 million and 783 million yuan for 2025 and 2026 [5]. - The company’s EBITDA for 2024 is estimated at 1.727 billion yuan, with a net profit margin of 14.99% [6][11]. - The company’s total assets are projected to reach 10.168 billion yuan by 2025, with a debt-to-asset ratio of 17.35% [11][12]. Product and Market Development - The company is focusing on expanding its product pipeline, with several projects in various clinical stages, including four in the NDA phase and three in Phase III clinical trials [4]. - New products like复立坦 and 信立汀他 have entered the national medical insurance catalog, laying a foundation for future growth [3]. - The company’s flagship product, 信立坦, continues to gain market share in the competitive hypertension drug market, particularly in grassroots markets [3].