普瑞巴林胶囊
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上海医药集团股份有限公司关于普瑞巴林胶囊获得菲律宾药品注册证书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-28 01:09
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"上海医药"或"公司")下属常州制药厂有限公司(以下简 称"常州制药厂")生产的普瑞巴林胶囊(以下简称"该药品")收到菲律宾食品药品监督管理局颁发的药 品注册证书,该药品获得批准上市。 一、该药品基本情况 药品名称:普瑞巴林胶囊 75mg:DRP-17499 150mg:DRP-14798 二、该药品相关的信息 普瑞巴林胶囊主要用于治疗带状疱疹后神经痛、糖尿病外周神经痛、纤维肌 剂型:胶囊 规格:50mg、75mg、150mg 注册分类:化学仿制药 申请事项:新产品上市 生产厂家:常州制药厂有限公司 注册证号: 50mg:DRP-17572 四、对上市公司影响及风险提示 本次普瑞巴林胶囊3个规格(50mg、75mg、150mg)获得菲律宾食品药品监督管理局的药品注册批文, 标志着公司具备了在菲律宾市场销售该药品的资格,对公司拓展海外市场带来积极影响,并积累了宝贵 的经验。 因受海外市场政策环境变化、汇率波动、市场竞争等不确定因素影响, ...
iza-bren公告III期结果;君实生物等药企发布业绩快报 | 健讯Daily
2 1 Shi Ji Jing Ji Bao Dao· 2026-02-28 00:19
Regulatory Updates - In 2025, the National Medical Products Administration (NMPA) received 457 special approval applications for innovative medical devices, with 104 approved for special review and 38 priority applications, of which 26 were granted priority approval [1] - By the end of 2025, 475 traditional Chinese medicine production bases passed inspections, covering nearly 1.24 million acres and providing 101 types of Chinese medicinal materials for 215 production enterprises [2] Company Announcements - Shanghai Pharmaceuticals announced that its pregabalin capsules received a drug registration certificate from the Philippines, with a total sales amount of $13.37 million for three specifications [2] - Jiukang Bio received a medical device registration certificate for its albumin assay kit, valid until February 12, 2031 [3] Clinical Research - Eli Lilly's orforglipron demonstrated superior efficacy in glycemic control and weight loss compared to oral semaglutide in a head-to-head study involving 1,698 participants [4][5] - The study results were published in The Lancet, indicating significant improvements in A1C and weight reduction with orforglipron [5] Financial Performance - Baili Tianheng reported a net loss of 1.051 billion yuan for 2025, a significant decline from the previous year, with total revenue of 2.520 billion yuan, down 56.72% [8] - Junshi Biosciences achieved a total revenue of 2.498 billion yuan in 2025, a year-on-year increase of 28.23%, but reported a net loss of 874 million yuan [8] - Yifang Bio reported a net loss of 317 million yuan for 2025, with total revenue of 37.3253 million yuan, down 77.89% [9] - Nanmo Bio's total revenue for 2025 was 421.2586 million yuan, up 10.50%, with a net profit increase of 399.29% to 32.4313 million yuan [10]
上海医药:关于普瑞巴林胶囊获得菲律宾药品注册证书的公告
Zheng Quan Ri Bao· 2026-02-27 12:43
证券日报网讯 2月27日,上海医药发布公告称,公司下属常州制药厂有限公司生产的普瑞巴林胶囊(以 下简称"该药品")收到菲律宾食品药品监督管理局颁发的药品注册证书,该药品获得批准上市。 (文章来源:证券日报) ...
上海医药(601607.SH):普瑞巴林胶囊获得菲律宾药品注册证书
Ge Long Hui A P P· 2026-02-27 09:48
格隆汇2月27日丨上海医药(601607.SH)公布,近日,公司下属常州制药厂有限公司生产的普瑞巴林胶囊 收到菲律宾食品药品监督管理局颁发的药品注册证书,该药品获得批准上市。 2019年10月,常州制药厂完成普瑞巴林胶囊的研发工作。2021年7月,常州制药厂的普瑞巴林胶囊获得 美国食品药品监督管理局批准文号,并于2025年6月获得泰国药品注册证书,于2026年1月获得新加坡药 品注册证书。截至本公告日,公司针对该药品在东南亚市场(即泰国、新加坡、马来西亚及菲律宾)上市 另投入的研发费用约人民币219万元。 普瑞巴林胶囊主要用于治疗带状疱疹后神经痛、糖尿病外周神经痛、纤维肌痛和脊髓损伤引起的神经性 疼痛以及癫痫的辅助治疗。 ...
上海医药(02607.HK):普瑞巴林胶囊获得菲律宾药品注册证书
Ge Long Hui· 2026-02-27 08:54
格隆汇2月27日丨上海医药(02607.HK)发布公告,近日,公司下属常州制药厂有限公司(以下简称"常州 制药厂")生产的普瑞巴林胶囊收到菲律宾食品药品监督管理局颁发的药品注册证书,该药品获得批准上 市。普瑞巴林胶囊主要用于治疗带状疱疹后神经痛、糖尿病外周神经痛、纤维肌痛和脊髓损伤引起的神 经性疼痛以及癫痫的辅助治疗。 ...
上海医药:普瑞巴林胶囊获菲律宾药品注册证书
Xin Lang Cai Jing· 2026-02-27 08:04
上海医药公告称,下属常州制药厂生产的普瑞巴林胶囊收到菲律宾食品药品监督管理局颁发的药品注册 证书,获批上市。该药品有50mg、75mg、150mg三个规格,主要用于治疗神经痛及癫痫辅助治疗。截 至公告日,公司针对该药品在东南亚市场上市另投入研发费用若干。2024年菲律宾市场已上市的同规格 药品销售总额为1337万美元。此次获批对公司拓展海外市场有积极影响,但受多种不确定因素影响,药 品销售可能不达预期。 ...
上海医药:普瑞巴林胶囊获得菲律宾药品注册证书
Jin Rong Jie· 2026-02-27 07:56
上海医药(601607.SH)公告称,下属常州制药厂有限公司生产的普瑞巴林胶囊收到菲律宾食品药品监督 管理局颁发的药品注册证书,该药品获得批准上市。普瑞巴林胶囊主要用于治疗带状疱疹后神经痛、 糖尿病外周神经痛、纤维肌痛和脊髓损伤引起的神经性疼痛以及癫痫的辅助治疗。该药品在东南亚市场 (即泰国、新加坡、马来西亚及菲律宾)上市另投入的研发费用约人民币219万元。菲律宾市场已上市 普瑞巴林胶囊3个规格(50mg、75mg、150mg)销售总额为1,337万美元。该药品获得菲律宾食品药品 监督管理局的药品注册批文,标志着公司具备了在菲律宾市场销售该药品的资格,对公司拓展海外市场 带来积极影响,并积累了宝贵的经验。但该药品可能存在销售不达预期等情况,具有较大不确定性,敬 请广大投资者谨慎决策,注意投资风险。 ...
步长制药子公司6款药品拟中选接续采购
Bei Jing Shang Bao· 2026-02-11 10:27
Core Viewpoint - The company announced that its subsidiaries and a holding subsidiary participated in a national procurement program and have proposed to be selected for six pharmaceutical products, with a procurement period extending until December 31, 2028 [1] Group 1: Company Participation - The company’s wholly-owned subsidiaries, including Shaanxi Buchang High-tech Pharmaceutical Co., Ltd. and Shandong Danhong Pharmaceutical Co., Ltd., along with its holding subsidiary Jilin Tiancheng Pharmaceutical Co., Ltd., are involved in the national organized procurement program [1] - The selected products include Amlodipine Besylate Tablets, Rivaroxaban Tablets, Metoprolol Tartrate Tablets, Lacosamide Tablets, Pregabalin Capsules, and Torasemide Injection [1] Group 2: Procurement Details - The procurement cycle for the selected drugs will commence from the actual execution date of the selection results and will last until December 31, 2028 [1]
上海医药(601607.SH):普瑞巴林胶囊获得新加坡药品注册证书
Ge Long Hui· 2026-01-23 22:33
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received a drug registration certificate from the Health Sciences Authority (HSA) of Singapore for its Pregabalin capsules, allowing the product to be marketed [1] Group 1: Product Approval and Indications - Pregabalin capsules are primarily used for the treatment of postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, spinal cord injury-related neuropathic pain, and as an adjunctive treatment for epilepsy [1] - The product's research and development were completed by Changzhou Pharmaceutical Factory in October 2019, and it received approval from the U.S. Food and Drug Administration in July 2021 [1] Group 2: Market Expansion and Investment - The drug has also been approved for market entry in Thailand by June 2025, indicating a strategic expansion into Southeast Asian markets [1] - The company has invested approximately RMB 2.19 million in research and development for the product's launch in Southeast Asia, which includes Thailand, Singapore, Malaysia, and the Philippines [1]
上海医药集团股份有限公司关于马来酸阿伐曲泊帕片获得批准生产的公告
Shang Hai Zheng Quan Bao· 2026-01-23 19:25
Group 1 - Shanghai Pharmaceuticals has received approval for the production of Avatrombopag Maleate Tablets from the National Medical Products Administration [1][2] - The drug is indicated for adult patients with chronic liver disease-related thrombocytopenia undergoing elective diagnostic procedures or surgery, and for adults with chronic primary immune thrombocytopenia (ITP) who have had inadequate responses to previous treatments [3] - The company has invested approximately RMB 9.8961 million in the research and development of this drug as of the announcement date [3] Group 2 - The drug's approval is expected to enhance market share and competitiveness, benefiting from greater support in medical insurance and procurement due to its new registration classification [5] - The total procurement amount for Avatrombopag Maleate Tablets in hospitals in mainland China is projected to be RMB 566.56 million in 2024 [4] Group 3 - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received a drug registration certificate for Pregabalin Capsules from the Health Sciences Authority of Singapore, allowing it to market the drug in Singapore [8][9] - Pregabalin Capsules are indicated for the treatment of neuropathic pain and as an adjunct therapy for epilepsy, with a total investment of approximately RMB 2.19 million in R&D for the Southeast Asian market [9] - The sales revenue for Pregabalin Capsules in Singapore is estimated to be USD 2 million in 2024 [11]