Core Viewpoint - The company, China National Pharmaceutical Group Modern (600420.SH), announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for a supplemental application regarding sodium bicarbonate injection, which includes an increase in specifications and has passed the consistency evaluation for generic drug quality and efficacy [1]. Group 1 - The sodium bicarbonate injection is classified as an antacid [1]. - Indications for sodium bicarbonate injection include: (1) treatment of metabolic acidosis; (2) prevention of uric acid kidney stones, reduction of nephrotoxicity from sulfonamides, and prevention of hemoglobin deposition in renal tubules during acute hemolysis; (3) intravenous infusion for non-specific treatment of certain drug poisonings, such as barbiturates, salicylates, and methanol [1].

Core Viewpoint - Harbin Pharmaceutical Group's subsidiary, Sanjing Mingshui, has received approval from the National Medical Products Administration for the supplementary application of Lercanidipine tablets, which have passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval and Market Impact - The approval of Lercanidipine tablets (4mg) enhances the market competitiveness of the product and is expected to increase its market share [1] - The drug is a highly selective calcium channel blocker that primarily dilates peripheral small arteries, reducing peripheral vascular resistance and lowering blood pressure [1] - The approval aligns with national policies that provide greater support for drugs that pass the consistency evaluation in areas such as medical insurance payments and procurement by medical institutions [1] Group 2: Strategic Implications for the Company - The successful evaluation of Lercanidipine tablets provides valuable experience for the company in conducting future consistency evaluations for other products [1]

Group 1 - The company Shanghai Pharmaceutical Group Co., Ltd. announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd., received a notification from the National Medical Products Administration approving the supplementary application for the drug Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1][2] - The drug Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, wheezing bronchitis, and obstructive pulmonary emphysema, and it was developed by Eisai Co., Ltd. and launched in Japan in October 1952 [2] - As of the announcement date, the company has invested approximately RMB 3.05 million in research and development for this drug [2] Group 2 - The approval of the drug's consistency evaluation is expected to enhance its market share and competitiveness, as products that pass this evaluation will receive greater support in medical insurance payments and procurement by medical institutions [2] - The total procurement amount for Dihydroxypropyl Theophylline Injection (2ml:0.3g) in hospitals in mainland China for 2024 is reported to be RMB 9.737 million [2]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a "Drug Supplement Application Approval Notice" from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - Dihydroxypropyl Theophylline Injection was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and combined consistency evaluation of the generic drug, which was accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd. (referred to as "Xinyi Jinzhu"), has received a Supplementary Application Approval Notice from the National Medical Products Administration (NMPA) for its Dihydroxypropyl Theophylline Injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The Dihydroxypropyl Theophylline Injection is indicated for bronchial asthma, asthmatic bronchitis, obstructive pulmonary emphysema, and relief of wheezing symptoms [1] - The drug can also be used for wheezing caused by cardiogenic pulmonary edema [1] - The drug was developed by Eisai Co., Ltd. and was launched in Japan in October 1952 [1] Group 2 - In August 2024, Xinyi Jinzhu submitted a supplementary application to the NMPA for the new specification and consistency evaluation of the generic drug, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 3.05 million in research and development costs for this drug [1]

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of injectable Cefotaxime [1][2] Drug Basic Information - The drug is injectable Cefotaxime with specifications of 0.5g and 1.0g, classified as a chemical drug [1] - The approval notification numbers are 2025B04013 and 2025B04015, with acceptance numbers CYHB2350966 and CYHB2350965 [1] - The drug is produced by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., located at 808 Binhai East Road, Haizhu District, Guangzhou [1] Drug Related Information - Tianxin Pharmaceutical obtained the registration certificate for injectable Cefotaxime in September 2002 and submitted the consistency evaluation application in December 2023 [3] - Injectable Cefotaxime is a third-generation cephalosporin antibiotic used for treating various infections, including severe systemic infections and respiratory tract infections [3] - The sales revenue for injectable Cefotaxime in 2024 is projected to be RMB 1,431.78 million, with total sales in China expected to reach RMB 185,877 million [3] R&D Investment - As of the announcement date, Tianxin Pharmaceutical has invested approximately RMB 1,036 million in the R&D project for injectable Cefotaxime [4]

Group 1 - The company *ST Shuangcheng (002693.SZ)* confirmed that several of its products have passed the consistency evaluation for generic drugs [2] - The products that have achieved this include Thymosin injection, Somatostatin injection, Octreotide injection, and Bortezomib injection [2]

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval for its generic drugs to pass the consistency evaluation of quality and efficacy, which is expected to enhance market competitiveness for the products [1][11]. Drug Information 1. Cefoperazone Sodium and Sulbactam Sodium Injection - The drug has been approved in three specifications: 1.0g, 1.5g, and 2.0g [1][6] - It is a third-generation cephalosporin antibiotic used for various infections, including respiratory, urinary, and intra-abdominal infections [6] - The product was originally developed by Pfizer and was first launched in Japan in June 1986, with its 1.0g specification approved in China in 1996 [6] - The sales revenue for Tianxin Pharmaceutical's cefoperazone sodium and sulbactam sodium injection in 2024 is projected to be RMB 15.897 million [7] - The company has invested approximately RMB 7.9186 million in the research and development of this product [7] 2. Clindamycin Phosphate Injection - The drug is available in two specifications: 2ml: 0.3g and 4ml: 0.6g, and was launched in 2006 [8][9] - It is primarily used for severe infections caused by sensitive anaerobic bacteria [9] - The sales revenue for Tianxin Pharmaceutical's clindamycin phosphate injection in 2024 is projected to be RMB 7.50787 million [10] - The company has invested approximately RMB 2.7329 million in the research and development of this product [10]

证券代码：601607 证券简称：上海医药 编号：临2025-080 上海医药集团股份有限公司 关于盐酸维拉帕米注射液通过仿制药一致性评价的公告 注册分类：化学药品 申请人：上海禾丰制药有限公司 药品批准文号：国药准字H31021343 审批结论：本品通过仿制药质量和疗效一致性评价。 二、该药品相关的信息 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个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"公司"）下属上海禾丰制药有限公司（以下简称"上药禾 丰"）的盐酸维拉帕米注射液（以下简称"该药品"）收到国家药品监督管理局（以下简称"国家药监 局"）颁发的《药品补充申请批准通知书》（通知书编号：2025B03892），该药品通过仿制药质量和疗 效一致性评价。 一、该药品基本情况 药品名称：盐酸维拉帕米注射液 剂型：注射剂 规格：2ml:5mg 根据国家相关政策，通过一致性评价的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。 因此上药禾丰的盐酸维拉帕米注射液通过仿制药一致性评价，有利于扩大该药品的市场份额，提升市场 竞争 ...

Trading Information Summary - On September 1, 2025, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (600332) closed at 26.61 yuan, up 0.23%, with a turnover rate of 1.73% and a trading volume of 243,300 shares, amounting to a transaction value of 651 million yuan [1] - On the same day, the net outflow of main funds was 27.59 million yuan, accounting for 4.24% of the total transaction value; the net outflow of retail funds was 25.91 million yuan, accounting for 3.98% of the total transaction value; while retail investors saw a net inflow of 53.50 million yuan, accounting for 8.22% of the total transaction value [1][3] Company Announcements Summary - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of generic drugs for two products: injectable cefoperazone sodium and sulbactam sodium (1.0g, 1.5g, 2.0g) and clindamycin phosphate injection (2ml: 0.3g, 4ml: 0.6g) [2] - The domestic sales revenue for injectable cefoperazone sodium and sulbactam sodium is projected to be 688.93 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 15.90 million yuan and R&D expenses around 7.92 million yuan [2] - The domestic sales revenue for clindamycin phosphate injection is expected to be 13.51 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 7.51 million yuan and R&D expenses approximately 2.73 million yuan [2]