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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
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]
上海医药:关于普瑞巴林胶囊获得新加坡药品注册证书的公告
Zheng Quan Ri Bao· 2026-01-23 12:16
Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, received a drug registration certificate from the Health Sciences Authority (HSA) of Singapore for the drug Pregabalin capsules, which has been approved for market launch [1]. Group 1 - The drug Pregabalin capsules have been officially approved for sale in Singapore [1]. - The approval was granted by the Health Sciences Authority (HSA) of Singapore [1].
上海医药普瑞巴林胶囊获新加坡药品注册证书
Bei Jing Shang Bao· 2026-01-23 11:04
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Singapore Food and Drug Administration for the marketing of Pregabalin capsules, indicating a significant milestone for the company in expanding its product offerings in the international market [1]. Group 1 - The approved Pregabalin capsules are primarily used for treating postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, and neuropathic pain due to spinal cord injury, as well as for adjunctive treatment of epilepsy [1].
上海医药(02607.HK):普瑞巴林胶囊获得新加坡药品注册证书
Ge Long Hui· 2026-01-23 09:46
Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) announced that its subsidiary, Changzhou Pharmaceutical Factory, has received a drug registration certificate from the Health Sciences Authority (HSA) of Singapore for Pregabalin capsules, which have been approved for market launch [1] Group 1 - The approved drug, Pregabalin capsules, is primarily used for the treatment of postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, and neuropathic pain due to spinal cord injury, as well as for adjunctive treatment of epilepsy [1]
上海医药(02607) - 海外监管公告
2026-01-23 09:43
香港交易及結算所有限公司和香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 中國上海,2026 年 1 月 24 日 於本公告日期,本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生;非執行董事為張文學先生;以及獨立非執行董事為顧朝陽先生、霍文遜先 生、王忠先生及萬鈞女士。 * 僅供識別 (於中華人民共和國註冊成立的股份有限公司) (股份代碼:02607) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而作出。 茲載列上海醫藥集團股份有限公司(「本公司」)在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於普瑞巴林膠囊獲得新加坡藥品註冊證書的公告》、 《上海醫藥集團股份有限公司關於馬來酸阿伐曲 ...
上海医药(601607) - 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
2026-01-23 08:00
证券代码:601607 证券简称:上海医药 编号:临 2026-007 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 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")下属上海上药信谊 药厂有限公司(以下简称"上药信谊")的马来酸阿伐曲泊帕片(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《药品注 册证书》(证书编号:2026S00156),该药品获得批准生产。 一、该药品基本情况 药品名称:马来酸阿伐曲泊帕片 剂型:片剂 规格:20mg(以 C29H34Cl2N6O3S2计) 注册分类:化学药品 4 类 药品批准文号:国药准字 H20263130 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册,发给药品注册证书。 二、该药品相关的信息 1 IQVIA 数据库显示,2024 年中国大陆医院采购马来酸阿伐曲泊帕片的金额 为人民币 56,656 万元。 三、对上市公司影响及 ...
上海医药(601607) - 上海医药集团股份有限公司关于普瑞巴林胶囊获得新加坡药品注册证书的公告
2026-01-23 08:00
证券代码:601607 证券简称:上海医药 编号:临2026-006 上海医药集团股份有限公司 关于普瑞巴林胶囊获得新加坡药品注册证书的公告 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")收到新加坡食品药品监督管理局(HSA)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 剂型:胶囊 规格:50mg、75mg、150mg 注册分类:化学仿制药 生产厂家:常州制药厂有限公司 注册证号:50mg:SIN17444P;75mg:SIN17443P;150mg:SIN17442P 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 痛和脊髓损伤引起的神经性疼痛以及癫痫的辅助治疗。 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,该 药品获得美国食品药品监督管理局 ...
上海医药(601607.SH):马来酸阿伐曲泊帕片获得批准生产
Ge Long Hui A P P· 2026-01-23 07:58
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received approval from the National Medical Products Administration for the production of Maleate Avatrombopag Tablets, which are indicated for adult patients with chronic liver disease-related thrombocytopenia and chronic primary immune thrombocytopenia (ITP) [1] Group 1: Product Approval - The Maleate Avatrombopag Tablets are approved for use in adult patients undergoing elective diagnostic procedures or surgeries related to chronic liver disease [1] - The product is also suitable for adult patients with chronic primary immune thrombocytopenia who have previously shown poor response to treatments such as corticosteroids and immunoglobulins [1] - The drug was originally developed by AkaRx Inc. in the United States and was launched in the U.S. market in 2018 [1] Group 2: Development and Investment - Shanghai Pharmaceuticals submitted the registration application for the drug to the National Medical Products Administration in August 2024, which has been accepted [1] - As of the date of the announcement, the company has invested approximately RMB 9.8961 million in the research and development of this product [1] Group 3: Market Competition - The main domestic manufacturers of this drug in China include Fosun Pharma (Jiangsu) Pharmaceutical Group Co., Ltd., Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd., and Qilu Pharmaceutical Co., Ltd. [1]
上海医药:马来酸阿伐曲泊帕片获得批准生产
Core Viewpoint - Shanghai Pharmaceuticals (601607) has received regulatory approvals for two of its products, indicating a positive development in its product pipeline and potential for revenue growth [1]. Group 1: Product Approvals - The company's subsidiary, Shanghai Pharmaceuticals Holding Co., Ltd., has obtained a Drug Registration Certificate from the National Medical Products Administration for its drug, Avatrombopag Maleate Tablets, allowing it to commence production [1]. - Additionally, the company's Changzhou Pharmaceutical Factory has received a Drug Registration Certificate from the Health Sciences Authority of Singapore for its drug, Prucalopride Capsules, enabling it to be marketed [1].
上海医药:普瑞巴林胶囊获得新加坡药品注册证书
Ge Long Hui· 2026-01-23 07:41
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 - The Pregabalin capsules are primarily used for treating postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, spinal cord injury-related neuropathic pain, and as an adjunct therapy 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 - The Pregabalin capsules also received approval from the Thai Food and Drug Administration for market entry by June 2025 [1] - The company has invested approximately RMB 2.19 million in research and development for the product's launch in Southeast Asian markets, including Thailand, Singapore, Malaysia, and the Philippines [1]