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 ...

每经AI快讯，12月2日，人福医药(600079.SH)公告称，公司控股子公司光谷人福收到国家药品监督管理 局签发的《药品注册申请终止通知书》，同意其撤回重组质粒-肝细胞生长因子注射液的注册申请。该 药品适用于治疗严重下肢缺血性疾病导致的肢体静息痛，为治疗用生物制品1类新药。光谷人福于2024 年12月递交上市注册申请，截至目前累计研发投入约为1.6亿元。公司决定主动撤回本次申请，将根据 监管要求和技术要求完善研究资料后重新申报。预计该事项不会对公司当期业绩造成重大影响。医药产 品研发周期长、环节多，存在不确定性，公司将及时履行信息披露义务。 登录新浪财经APP 搜索【信披】查看更多考评等级 ...

Group 1 - Company provided a guarantee of 80 million RMB for its wholly-owned subsidiary, Shaanxi Buchang Pharmaceutical Co., Ltd., in a loan agreement with Huaxia Bank [2][7] - The board approved a total financing limit of up to 6.92 billion RMB for 2025, with specific guarantee limits for subsidiaries based on their debt ratios [3][12] - As of the announcement date, the total amount of guarantees provided by the company and its subsidiaries was 2.296 billion RMB, accounting for 22.48% of the company's audited net assets as of the end of 2024 [14] Group 2 - The company’s wholly-owned subsidiary, Shandong Danhong Pharmaceutical Co., Ltd., signed a contract with Beijing Excellent Future International Pharmaceutical Technology Development Co., Ltd. for clinical trials of a new drug [17] - The total cost for the clinical trial is 60.338 million RMB, covering 480 cases, with provisions for adjustments based on the final sample size [19] - This contract is expected to enhance the company's drug research and development capabilities, potentially saving time and costs in clinical trials [34] Group 3 - The company’s subsidiary, Shaanxi Buchang, received approval for changes to its drug production license, allowing for the addition of a new production line for tablets [42] - The changes are anticipated to optimize production structure and maintain stable production capacity to meet market demand [43]

Core Viewpoint - The company announced the withdrawal of the drug registration application for "Chai Huang Li Dan Capsule" by its wholly-owned subsidiary, Beijing Yiling Pharmaceutical Co., Ltd, as per the notification from the National Medical Products Administration [1][2]. Group 1: Drug Registration Update - Beijing Yiling received approval to withdraw the registration application for "Chai Huang Li Dan Capsule," an innovative traditional Chinese medicine developed by the company [1]. - The capsule is intended for treating chronic cholecystitis with liver and gallbladder damp-heat, and related gastrointestinal symptoms [1]. - The new drug registration application was initially accepted by the National Medical Products Administration in June 2024 [1]. Group 2: Future Actions and Impact - Beijing Yiling will enhance the registration materials according to the latest requirements from the National Medical Products Administration and will resubmit the application promptly [2]. - The withdrawal of the registration application is not expected to have a significant impact on the company's current and future operations and performance [2]. - The company emphasizes the importance of drug research and development while managing R&D costs, acknowledging the high risks and long cycles associated with drug development [2].

Core Viewpoint - The announcement indicates that the company’s wholly-owned subsidiary, Shandong Danhong Pharmaceutical, has signed a clinical trial outsourcing contract with Beijing Zhuoyue Future for the registration of a new drug, which is expected to enhance the company's research and development capabilities and reduce costs [1] Group 1 - The contract involves a total of 480 cases (including a 20% dropout rate) with a total price of 60.338 million yuan (including tax) [1] - If the final sample size exceeds 520 cases, the additional cases will be charged at a rate of 108,890 yuan per case (including tax) [1] - Shandong Danhong's revenue for 2024 is projected to be 1.331 billion yuan, with a net profit of 226 million yuan; for the first nine months of 2025, revenue is reported at 1.402 billion yuan and net profit at 334 million yuan [1]

博雅生物公告，近日收到国家药品监督管理局签发的破伤风人免疫球蛋白《药品注册证书》(证书编 号：2025S03488)。破伤风人免疫球蛋白剂型为注射剂，规格为每瓶含破伤风抗体250IU（2.5ml）。公 司本次获得破伤风人免疫球蛋白《药品注册证书》，进一步丰富公司的产品管线，有助于提升公司的研 发积极性。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its product "Cough Orange Granules," which is already in production and sales [1] Group 1: Product Information - "Cough Orange Granules" is a national secondary protected traditional Chinese medicine with functions for "clearing the lungs, stopping cough, and resolving phlegm" [1] - The product is indicated for cough with phlegm due to phlegm-heat obstructing the lungs, characterized by symptoms such as excessive phlegm, chest fullness, shortness of breath, dry throat, and itching [1] Group 2: Clinical Trial Approval - The company submitted an application to add a new indication for "acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat obstructing the lungs)" and received approval for clinical trials [1] - This approval represents a milestone in the company's drug development efforts [1] Group 3: Financial Impact - The approval of the clinical trial does not have a significant impact on the company's short-term financial status or operating performance [1] - The sales of the product will not be affected by the receipt of the clinical trial approval notification [1]

Group 1: Pharmaceutical Business Performance - In the first half of 2025, the pharmaceutical segment achieved a revenue of CNY 4.751 billion, representing a year-on-year growth of 10.8% [2] - Sales revenue of Yunnan Baiyao aerosol exceeded CNY 1.453 billion, with a significant year-on-year increase of over 20.9% [2] - Other traditional Chinese medicine products showed remarkable growth, with sales of Canling Jianpi Granules exceeding CNY 100 million and Pudilan Anti-inflammatory Tablets nearing CNY 100 million [2] - Plant-based products, such as Qixue Kang Oral Liquid, reached sales of CNY 202 million, with a year-on-year growth of approximately 116.2% [2] Group 2: Nuclear Medicine R&D Progress - The INR101 diagnostic nuclear medicine project has initiated Phase III clinical trials, with 32 research centers established and 22 activated, enrolling 60 subjects [3] - The INR102 therapeutic nuclear medicine project has received a clinical trial notification, with Phase I trials underway and 12 patients enrolled for Phase II trials [3] Group 3: Health Products Business Performance - The health products segment reported a revenue of CNY 3.442 billion in the first half of 2025, reflecting a year-on-year growth of 9.46% [4] - The segment focuses on a full-channel operation strategy, enhancing offline distribution capabilities and increasing online channel investments [4] - The oral care category, particularly gum care toothpaste, maintains and gradually expands its leading advantage, while anti-sensitivity toothpaste shows breakthrough growth [4] Group 4: Online Sales Performance - The pharmaceutical segment's online sales increased by over 20% year-on-year, with a GMV of CNY 254 million generated from 4.845 million visitors [5] - Yunnan Baiyao toothpaste holds the top market share in the domestic all-channel market, while Yangyuanqing shampoo ranked first in Tmall's domestic anti-hair loss category during the 2025 "618" shopping festival [5] Group 5: Dividend Distribution - For the 2024 fiscal year, the company distributed a cash dividend of CNY 11.85 per 10 shares, totaling CNY 2.164 billion [6] - The total cash dividend for 2024, including special dividends, amounted to CNY 23.98 per 10 shares, representing 90.09% of the net profit attributable to shareholders [7] - In the first half of 2025, the company distributed a cash dividend of CNY 10.19 per 10 shares, totaling CNY 1.818 billion, with special dividends accounting for 50.05% of the net profit for the period [7]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不會就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致之任何損失承擔任何責任。 自願公告 產品開發的最新進展 石四藥集團有限公司（「本公司」，連同其附屬公司，「本集團」）董事局（「董事局」）欣然公告， 本集團已取得中國國家藥品監督管理局（「國家藥監局」）有關氨茶鹼片（100mg）的藥品生產 註冊批件，屬於化學藥品第3類，視同通過一致性評價，是國內企業第三家獲批。氨茶鹼片主要 用於支氣管哮喘、喘息型支氣管炎、阻塞性肺氣腫等緩解喘息症狀，也可用於治療心源性肺水 腫引起的哮喘。本集團的氨茶鹼原料藥已獲國家藥監局批准登記成為在上市製劑使用的原料藥。 董事局亦欣然公告，本集團已取得國家藥監局有關鹽酸丙卡特羅吸入溶液(0.5ml：50μg)及注射 用丁二磺酸腺苷蛋氨酸(0.5g)的藥品生產註冊批件，分別屬於化學藥品第3類及第4類，視同通 過一致性評價。鹽酸丙卡特羅吸入溶液主要用於緩解支氣管哮喘、慢性支氣管炎及肺氣腫以氣 流受限為基礎的各種症狀。注射用丁二磺酸腺苷蛋氨酸主要用於治療肝硬化前和肝 ...

Core Viewpoint - The company reported a revenue of 19.89 billion yuan for the first three quarters of 2025, representing a year-on-year decrease of 12.3%, but a growth of 3.4% year-on-year in Q3, with a net profit of 3.51 billion yuan, down 7.1% year-on-year, but a significant increase of 27% year-on-year in Q3 [1][2]. Group 1: Financial Performance - Revenue for Q3 2025 was 9.6 billion yuan, with an estimated internal profit of nearly 600 million yuan [1]. - The decline in revenue for the first three quarters was primarily due to the impact of the collection of authorized income in the drug business, which has now narrowed, and the gradual dissipation of the impact from the procurement of Duomeisu [1][2]. - The company expects continued improvement in revenue in Q4 2025, driven by the market expansion of new products such as Omaguzumab and Mingfule [1][2]. Group 2: Drug Business Outlook - The drug business revenue decreased by 17.2% year-on-year for the first three quarters of 2025, but the decline narrowed significantly compared to Q2 [2]. - The company anticipates a return to positive growth in the drug business by 2026, supported by the absence of major products in the 14th batch of centralized procurement and the market expansion of already launched products [2]. - New products such as TG103, HER2 bispecific antibodies, and Bai Zhi II are expected to be approved in 2026, contributing to revenue growth [2]. Group 3: Clinical Development - The company is actively advancing the clinical trials for EGFR ADC both domestically and internationally, with plans for Phase III trials in the near future [3]. - The focus of the clinical trials includes NSCLC classic mutations and wild-type cases, indicating a competitive ADC pipeline with strong data quality and enrollment [3]. Group 4: Business Development and Pipeline - The company confirmed a business development (BD) revenue of 1.54 billion yuan for the first three quarters of 2025, with four transactions completed [4]. - The company has a robust pipeline in oncology, metabolism, autoimmune diseases, and small nucleic acids, which is expected to support BD efforts in 2026 [4]. - Profit forecasts for 2025-2027 are adjusted to 4.552 billion yuan, 4.628 billion yuan, and 5.029 billion yuan respectively, with corresponding EPS estimates [4].