本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，浙江海正药业股份有限公司（以下简称"公司"）收到国家药品监督管理局（以下简称"国家药监 局"）核准签发的他克莫司胶囊《药品补充申请批准通知书》，公司药品他克莫司胶囊已通过仿制药质 量和疗效一致性评价。现就相关情况公告如下： 一、药品的基本情况 药品名称：他克莫司胶囊 剂型：胶囊剂 规格：0.5mg、1mg 注册分类：化学药品 上市许可持有人：浙江海正药业股份有限公司 生产企业：浙江海正药业股份有限公司 2024年12月5日，国家药监局受理了公司递交的他克莫司胶囊一致性评价申请。截至目前，公司针对该 药品仿制药质量和疗效一致性评价已投入约6,144.39万元人民币。 三、对上市公司影响及风险提示 根据国家相关政策，通过一致性评价的药品品种在医保支付及医疗机构采购等领域将获得更大的支持力 度，因此公司的他克莫司胶囊通过仿制药一致性评价，有利于扩大上述药品的市场份额，提升市场竞争 力。 受理号：CYHB2450594、CYHB2450593 通知书编号：2025B04548、20 ...

普洛药业公告，全资子公司浙江普洛巨泰药业有限公司收到国家药品监督管理局下发的头孢泊肟酯片 《药品补充申请批准通知书》。头孢泊肟酯片为口服广谱第三代头孢菌素，适用于敏感菌引起的上呼吸 道感染、下呼吸道感染、单纯性泌尿道感染、单纯性皮肤和皮肤软组织感染、急性单纯性淋球菌性尿道 炎和子宫颈炎、由奈瑟氏淋球菌引起的肛周炎等。2024年度国内销售金额达到1.28亿元，其中临床医院 市场销售金额为1.08亿元，零售药店市场销售金额达0.2亿元。截至公告披露日，累计研发投入为817.68 万元。通过一致性评价有利于市场拓展和销售，提升产品市场竞争力，对公司未来发展具有积极作用。 ...

国药容生维生素B6注射液增加规格并通过一致性评价，将有利于该产品未来的市场拓展和销售。上述 事项对公司目前经营业绩不会产生重大影响。 国药现代（600420）(600420.SH)发布公告，近日，公司全资子公司国药集团容生制药有限公司(简称国 药容生)收到国家药品监督管理局核准签发的《药品补充申请批准通知书》，批准维生素B6注射液增加 规格并通过仿制药质量和疗效一致性评价(以下简称一致性评价)，核发药品批准文号。 ...

国药现代公告，旗下全资子公司国药容生收到国家药监局核发的《药品补充申请批准通知书》，批准维 生素B6注射液增加1ml:0.1g规格并通过仿制药质量和疗效一致性评价。维生素B6注射液主要用于预防和 治疗维生素B6缺乏症及其他相关适应症。2024年该药品在全国公立医疗机构的销售额约为3.04亿元。截 至目前，国药容生在该项目的累计研发投入为408.85万元。此次批准有利于该产品的市场拓展和销售， 但对公司目前经营业绩影响不大。 ...

Core Viewpoint - ST HuLuWa (605199.SH) has received the drug registration certificate for Cefdinir capsules from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product line [1] Company Summary - The approved drug, Cefdinir, is a third-generation broad-spectrum cephalosporin antibiotic, effective against various bacterial strains including Staphylococcus, Streptococcus, and Escherichia coli [1] - Cefdinir is indicated for treating multiple infections such as pharyngitis, tonsillitis, acute bronchitis, pneumonia, otitis media, and urinary tract infections among others [1] - The approval signifies that the drug meets the technical requirements for quality and efficacy consistent with reference formulations, and it is considered to have passed the consistency evaluation for generic drug quality and efficacy [1] Industry Summary - The approval of Cefdinir aligns with the growing demand for effective antibiotics in the healthcare sector, particularly for treating bacterial infections [1] - The regulatory approval process highlights the importance of compliance with quality standards in the pharmaceutical industry, which can impact market competitiveness [1]

Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. announced that its subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Amlodipine Besylate Tablets from the National Medical Products Administration, which is expected to enhance the company's product line and market competitiveness [1][2]. Drug Registration Details - The drug registered is Amlodipine Besylate Tablets, available in dosages of 5mg and 10mg, classified as a chemical drug of category 4, and is a prescription medication [1][2]. - The sales revenue for Amlodipine Besylate Tablets in hospitals across China reached 1.216 billion yuan in 2024 [2]. R&D Investment and Production - As of the announcement date, the R&D investment for Amlodipine Besylate Tablets by Changle Pharmaceutical is approximately 3.83 million yuan (unaudited) [2]. - Changle Pharmaceutical has obtained four production licenses for the drug as of the announcement date [2]. Impact on the Company - The acquisition of the Drug Registration Certificate is expected to enrich the product line of the company and its subsidiaries, thereby enhancing their market competitiveness [2]. - The impact on the company's recent operating performance is not expected to be significant [2].

Core Viewpoint - The company has received approval from the National Medical Products Administration for the potassium chloride injection, which will enhance its market competitiveness and sales potential [1][5]. Group 1: Product Approval and Specifications - The potassium chloride injection is approved in a new specification of 10ml:1.5g, in addition to the existing 10ml:1g [1][2]. - The product is indicated for the treatment and prevention of hypokalemia, particularly when oral potassium supplementation is not feasible [1]. Group 2: Research and Development - The company initiated research for the new specification in June 2023 and submitted the application for approval in August 2024, receiving acceptance shortly thereafter [2]. - Cumulative R&D investment for the potassium chloride injection has reached 1.6109 million RMB (approximately 0.24 million USD) [2]. Group 3: Market Landscape - As of 2024, the global sales of potassium chloride injection are projected to be 22.3 million USD [2]. - In the domestic market, the total sales of potassium chloride injection are estimated at 617 million RMB (approximately 93.5 million USD) for 2024, with the top five companies holding significant market shares [3]. - The company reported a sales revenue of 960,000 RMB (approximately 0.14 million USD) for its potassium chloride injection in 2024 [4].

Core Viewpoint - China Resources Double Crane Pharmaceutical (600062.SH) announced that its wholly-owned subsidiary, Anhui Double Crane Pharmaceutical Co., Ltd., received the approval notice from the National Medical Products Administration for the potassium chloride injection, which includes a new specification of 10ml:1.5g [1] Group 1 - The potassium chloride injection is used for the treatment and prevention of hypokalemia, particularly when oral potassium supplementation is not feasible [1] - The approval of the potassium chloride injection will enhance future market sales and competition, while also providing valuable experience for subsequent consistency evaluations of generic drugs [1]

Group 1 - The company has received approval from the National Medical Products Administration for the acetyl dexamethasone tablets, which have passed the consistency evaluation of quality and efficacy for generic drugs [1][2] - The approved specification for the acetyl dexamethasone tablets is 0.75mg, with the drug approval number being H33020822 [2] - Acetyl dexamethasone tablets are corticosteroids primarily used for allergic and autoimmune inflammatory diseases, including connective tissue diseases, severe bronchial asthma, dermatitis, ulcerative colitis, acute leukemia, and malignant lymphoma [1][2] Group 2 - The approval of acetyl dexamethasone tablets is expected to strengthen and enhance the product's market competitiveness, providing valuable experience for the company's future consistency evaluation work [2]

Core Viewpoint - The company has announced its half-year report, detailing its financial performance, profit distribution plan, and future development strategies, emphasizing significant expected profit growth for 2024 [1][6]. Group 1: Financial Performance - The company plans to distribute a cash dividend of 0.30 yuan per 10 shares to all shareholders, based on a total of 595,987,425 shares [3]. - The projected net profit for 2024 is estimated to be between 115 million yuan and 145 million yuan, representing a year-on-year growth of 159.26% to 226.90% [6]. Group 2: Corporate Governance - The company has not experienced any changes in its controlling shareholder or actual controller during the reporting period [5]. - Several board members, including the chairman and other directors, have submitted resignation letters for personal reasons, indicating potential shifts in corporate governance [11][14][21]. Group 3: Related Party Transactions - The company anticipates daily related party transactions with Chongqing Southwest Synthetic Pharmaceutical Co., Ltd. not exceeding 13.04 million yuan and with Ping An Group and other related parties not exceeding 115.77 million yuan for 2025 [7]. - The company has identified that some related party transactions in 2024 exceeded the expected amounts and will be confirmed accordingly [7]. Group 4: Investment and Financing - The company plans to apply for a total bank credit line of 900 million yuan for operational needs, with guarantees provided for its wholly-owned subsidiaries [8]. - A new wholly-owned subsidiary is to be established with a registered capital of up to 30 million yuan to enhance the company's industry influence and international development [10]. Group 5: Regulatory Approvals - The company has received approval from the National Medical Products Administration for its product, injectable cefazolin sodium, confirming its consistency in quality and efficacy [17]. - Another product, ondansetron hydrochloride tablets, has also passed the same evaluation, indicating the company's commitment to maintaining high standards in its pharmaceutical offerings [19]. Group 6: Structural Changes - The company is revising its articles of association to eliminate the supervisory board, transferring its powers to the audit committee, which reflects a shift in governance structure [22][23].