仿制药质量和疗效一致性评价
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津药药业:子公司盐酸甲氧氯普胺注射液获得药品注册证书
Xin Lang Cai Jing· 2025-11-11 07:48
Core Viewpoint - The company announced that its subsidiary, Hubei Jinyao Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the registration certificate of Methoclopramide Hydrochloride Injection, which is expected to positively impact the company's performance and market expansion in the domestic formulation sector [1] Group 1 - The approved drug is classified as a Class 3 chemical drug and has passed the consistency evaluation of quality and efficacy for generic drugs [1] - The approval enhances the company's formulation product portfolio, which is anticipated to contribute positively to the company's performance [1] - The development, production, and sales of pharmaceuticals are subject to significant uncertainties due to national policies and market conditions [1]
北陆药业:碘美普尔注射液获得药品注册证书
Xin Lang Cai Jing· 2025-11-10 08:21
Core Viewpoint - The company has received approval from the National Medical Products Administration for the iodine-based contrast agent, Iodixanol Injection, which enhances its product lineup in the contrast agent segment [1] Group 1: Product Approval - The Iodixanol Injection has been approved as a Class 4 chemical drug, indicating it has passed the consistency evaluation for generic drug quality and efficacy [1] - This approval allows the company to diversify its iodine contrast agent product offerings [1] Group 2: Business Development - The company's subsidiary, Zhejiang Haichang Pharmaceutical Co., Ltd., is expected to have the raw material for Iodixanol approved for market launch by August 2025 [1] - The business model of "raw material + formulation" for Iodixanol has been established, indicating a comprehensive approach to product development [1] Group 3: Market Strategy - The company plans to actively prepare for the launch of new products and aims to bring them to market as soon as possible [1] - However, the production and sales of these products may face some uncertainties [1]
南京健友生化制药股份有限公司关于那屈肝素钙注射液通过仿制药质量和疗效一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-11-06 19:10
Core Viewpoint - Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its enoxaparin sodium injection to pass the consistency evaluation of generic drug quality and efficacy [1][2]. Drug Basic Information - Drug Name: Enoxaparin Sodium Injection - Indications: Used in surgical procedures to prevent venous thromboembolism in moderate to high-risk situations, treat existing deep vein thrombosis, and in combination with aspirin for unstable angina and non-Q wave myocardial infarction. It is also used to prevent clot formation during hemodialysis [1][2]. - Dosage Forms: Injection (pre-filled syringe products) [2]. - Specifications: 0.3ml: 3075AXaIU and 0.6ml: 6150AXaIU [2]. - Original Drug Approval Numbers: National Drug Approval Number H20194077 and H20191005 [2]. Other Relevant Information - The company has invested approximately RMB 23.56 million in research and development for the consistency evaluation of the enoxaparin sodium injection [3]. - Currently, there are eight companies, including Jianyou, that have launched generic versions of enoxaparin sodium injection in China [3]. Impact on the Company - The approval of the consistency evaluation will provide greater support for the drug in terms of medical insurance payments and procurement by medical institutions. It also qualifies the product for participation in national drug centralized procurement [4]. - The successful evaluation is expected to enhance the market sales and competitiveness of the enoxaparin sodium injection [5].
石四药集团:维生素B6注射液(1ml:0.1g)已取得国家药监局批准通过仿制药质量和疗效一致性评价
Zhi Tong Cai Jing· 2025-11-03 00:06
Core Viewpoint - The company Shijiazhuang Four Medicines Group has received approval from the National Medical Products Administration of China for its Vitamin B6 injection (1ml:0.1g) to pass the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The Vitamin B6 injection is primarily used for the prevention and treatment of Vitamin B6 deficiency [1] - It can also be utilized in cases of pregnancy, radiation sickness, and vomiting caused by anticancer drugs, as well as seborrheic dermatitis and hereditary Vitamin B6 dependency syndrome in newborns [1]
北京中关村科技发展(控股)股份有限公司关于下属公司北京华素盐酸纳曲酮片通过一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-10-31 19:20
Core Viewpoint - Beijing Zhongguancun Science and Technology Development (Holding) Co., Ltd. announced that its subsidiary, Beijing Huasu Pharmaceutical Co., Ltd., has successfully passed the consistency evaluation for the drug "Naltrexone Hydrochloride Tablets" [1][2] Group 1: Drug Approval and Details - The drug "Naltrexone Hydrochloride Tablets" (specification: 50mg) has received approval from the National Medical Products Administration, confirming its quality and efficacy consistency evaluation [1][2] - The original manufacturer of Naltrexone is TEVA WOMENS, which received approval in the United States in 1984 under the brand name REVIA [2] - Currently, there are no original or imported generic versions of this drug available in China, making Beijing Huasu the sole provider of this product in the market [2] Group 2: Financial and R&D Investment - The total research and development investment for the consistency evaluation project of Naltrexone Hydrochloride Tablets has reached 11.7389 million yuan [3] Group 3: Market Impact and Competitive Advantage - The approval of the consistency evaluation is expected to enhance the company's market competitiveness and positively impact its operating performance [4] - The drug will receive support in terms of medical insurance payments, and medical institutions are encouraged to prioritize its procurement and clinical use [4] - The successful evaluation provides valuable experience for the company in conducting future consistency evaluations for other generic drugs [4]
国药现代:法莫替丁注射液通过仿制药质量和疗效一致性评价
Zhi Tong Cai Jing· 2025-10-17 11:32
Core Viewpoint - The company Guoyao Modern (600420.SH) announced that its wholly-owned subsidiary, Guoyao Group Rongsheng Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplementary application of Famotidine injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - Guoyao Modern's subsidiary has been granted a supplementary application approval for Famotidine injection [1] - Famotidine is an H2 receptor antagonist used for treating upper gastrointestinal bleeding caused by various factors, excluding tumors and esophageal or gastric varices [1] - The approval indicates the company's capability to produce a drug that meets regulatory standards for quality and efficacy [1]
证券代码:002332 证券简称:仙琚制药 公告编号:2025-043
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-10-14 05:26
Core Viewpoint - Zhejiang Xianju Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of its Acetate Dexamethasone Tablets, which enhances the company's market competitiveness [1][2]. Group 1: Drug Information - The company has successfully passed the consistency evaluation for the 0.5mg specification of Acetate Dexamethasone Tablets, with the drug approval number being Guoyao Zhunzi H20258221 [2]. - The 0.75mg specification of Acetate Dexamethasone Tablets was previously approved in August 2025 [2]. - Acetate 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]. Group 2: Regulatory and Approval Process - The approval was based on the Drug Administration Law of the People's Republic of China and relevant government opinions on the reform of drug and medical device review and approval systems [1]. - The product adheres to the national drug registration standards YBH26782025 set by the National Medical Products Administration [2]. Group 3: Company Impact - The approval of the 0.5mg specification is expected to strengthen and enhance the product's market competitiveness and provide valuable experience for future drug consistency evaluations [2].
浙江海正药业股份有限公司 关于公司药品通过仿制药一致性评价的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-10-01 05:23
Core Points - Zhejiang Haizheng Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the tacrolimus capsule, which has passed the consistency evaluation of generic drug quality and efficacy [1][2] Group 1: Drug Information - The drug name is tacrolimus capsule, available in dosages of 0.5mg and 1mg, classified as a chemical drug [1] - The original drug was developed by Astellas Pharma Co., Limited, and is primarily used to prevent organ rejection after liver or kidney transplants [2] - The global sales of tacrolimus capsules are projected to be approximately $138.73 million in 2024, with domestic sales around $46.16 million [2] Group 2: Company Impact - The approval of tacrolimus capsules for consistency evaluation is expected to enhance the company's market share and competitiveness in the pharmaceutical industry [3] - The company has invested approximately 61.44 million RMB in the consistency evaluation of this drug [2]
普洛药业:头孢泊肟酯片通过仿制药质量和疗效一致性评价
Xin Lang Cai Jing· 2025-09-29 07:47
Core Viewpoint - The announcement indicates that the company's wholly-owned subsidiary, Zhejiang Pro Pharmaceutical Co., Ltd., has received approval for the drug Cefoperazone Ester Tablets from the National Medical Products Administration, which is expected to enhance market competitiveness and positively impact future development [1] Group 1: Product Approval - The drug Cefoperazone Ester Tablets is an oral broad-spectrum third-generation cephalosporin, suitable for treating infections caused by sensitive bacteria, including upper and lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, and gonococcal infections [1] - The approval is expected to facilitate market expansion and sales through consistency evaluation, thereby enhancing the product's market competitiveness [1] Group 2: Market Potential - The projected domestic sales for the year 2024 are estimated to reach 128 million yuan, with clinical hospital sales amounting to 108 million yuan and retail pharmacy sales reaching 20 million yuan [1] - Cumulative R&D investment up to the date of the announcement is 8.1768 million yuan, indicating a commitment to product development [1]
国药现代:国药容生维生素B6注射液增加规格并通过一致性评价
Zhi Tong Cai Jing· 2025-09-22 09:00
Core Viewpoint - 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 for Vitamin B6 injection, allowing for an increase in specifications and passing the consistency evaluation for generic drug quality and efficacy [1] Group 1 - The approval of the Vitamin B6 injection will facilitate market expansion and sales for the product in the future [1] - The recent developments are not expected to have a significant impact on the company's current operating performance [1]