证券代码：601607 证券简称：上海医药 编号：临2026-017 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 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 剂型：胶囊 规格：50mg、75mg、150mg 150mg：DRP-14798 二、该药品相关的信息 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 75mg：DRP-17499 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，常 州制药厂的普瑞巴 ...

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received a drug registration certificate from the Philippines Food and Drug Administration for the launch of Pregabalin capsules, which are approved for sale in three specifications: 50mg, 75mg, and 150mg. This approval is expected to positively impact the company's expansion into overseas markets, although there are various uncertainties that may affect sales performance [1]. Group 1 - The drug Pregabalin is primarily used for the treatment of neuropathic pain and as an adjunct therapy for epilepsy [1]. - The total sales for the same specifications of the drug in the Philippines market for 2024 are projected to be $13.37 million [1]. - The company has invested additional research and development expenses for the drug's market entry in Southeast Asia [1].

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) has received a drug registration certificate from the Philippines Food and Drug Administration for its Pregabalin capsules, allowing the product to be marketed in the Philippines [1] Group 1: Product Approval and Market Impact - The Pregabalin capsules are primarily used for treating postherpetic neuralgia, diabetic peripheral neuropathy, fibromyalgia, spinal cord injury-related neuropathic pain, and as an adjunctive treatment for epilepsy [1] - The approval marks the company's qualification to sell the drug in the Philippines, which is expected to positively impact the company's expansion into overseas markets and accumulate valuable experience [1] Group 2: Financial and Market Data - The total sales amount for Pregabalin capsules in the Philippines market across three specifications (50mg, 75mg, 150mg) is reported to be $13.37 million [1] - The research and development expenses incurred for launching the product in the Southeast Asian market (including Thailand, Singapore, Malaysia, and the Philippines) amount to approximately RMB 2.19 million [1]

Regulatory Updates - The National Medical Products Administration (NMPA) has released the "Guidelines for Pharmaceutical Research on Chemical Drugs for Rare Diseases (Trial)" to enhance support for rare disease drug development and improve technical guidance principles [1] - Hengrui Medicine's innovative drug SHR-1918 injection has been accepted for priority review by the NMPA, aimed at treating patients with homozygous familial hypercholesterolemia [1] - CanSino Biologics has expanded the age range for its ACYW135 meningococcal polysaccharide conjugate vaccine from children aged 3 months to 3 years to those aged 3 months to 6 years, which is expected to positively impact the company's performance [2] - Tongrentang Pharmaceutical has received product registration approval from Health Canada for several products, including children's cough syrup, although further administrative approvals are required for sales [3] - Shanghai Pharmaceuticals has obtained a drug registration certificate in Singapore for rivaroxaban tablets, which are used to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation patients [4] - Baotai has received acceptance for the marketing authorization application of its drug BAT4406F, intended for treating adult patients with AQP4 antibody-positive neuromyelitis optica spectrum disorder [5] Industry Developments - Zhejiang Medicine plans to invest 250 million yuan in a silver economy fund in collaboration with a private equity fund, focusing on the healthcare sector [6] - Zhijiang Biology has completed a strategic increase in its stake in Sanyou Biopharmaceuticals, enhancing its position in the precision medicine sector [7] - Xianweida Biopharmaceutical has entered a commercialization agreement with Pfizer China for its GLP-1 receptor agonist, which could yield up to $495 million in payments [8] Financial Performance - Sangfor Technologies reported a projected net profit increase of 317.09% for 2025, driven by a significant collaboration with Pfizer that resulted in a revenue recognition of approximately 2.89 billion yuan [9] Capital Market Activities - Duorui Pharmaceuticals announced a stock suspension following the expiration of a tender offer period, pending confirmation of the offer results [10] - Jiutian Pharmaceutical completed a share buyback of 1.24% of its total shares, with a total transaction amount of 100 million yuan [11] - Shenlian Biopharmaceutical plans to acquire controlling interest in Shiziyuan Biotechnology for 237 million yuan, aiming to expand into innovative drug business [12]

Core Viewpoint - Shanghai Pharmaceuticals has received a drug registration certificate from the Health Sciences Authority of Singapore for its rivaroxaban tablets, allowing the product to be marketed in Singapore [1][4]. Group 1: Drug Basic Information - Drug Name: Rivaroxaban Tablets - Dosage Forms: Tablets - Specifications: 10mg, 15mg, 20mg - Registration Classification: Chemical Generic Drug - Manufacturer: Changzhou Pharmaceutical Factory Co., Ltd. - Registration Numbers: 10mg: SIN17463P, 15mg: SIN17462P, 20mg: SIN17461P [2]. Group 2: Drug Indications - Rivaroxaban tablets are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment and prevention of deep vein thrombosis (DVT); for the treatment of pulmonary embolism (PE); and for the prevention of venous thromboembolism (VTE) in acutely ill patients [2]. Group 3: Market Competition - As of the announcement date, there are six other approved manufacturers in Singapore for rivaroxaban tablets, with BAYER being the main seller. The total sales amount for the three specifications (10mg, 15mg, 20mg) in the Singapore market is projected to be $8 million in 2024 [3]. Group 4: Impact on the Company - The approval of rivaroxaban tablets for sale in Singapore is expected to positively impact the company's efforts to expand into overseas markets and accumulate valuable experience [4].

Group 1 - Hengyu Environmental reported a revenue of 294 million yuan for 2025, an increase of 89.87%, and a net profit of 35.93 million yuan, up 106.25% year-on-year [1] - Yongxi Electronics achieved a revenue of 4.4 billion yuan in 2025, a growth of 21.92%, with a net profit of 82.24 million yuan, reflecting a year-on-year increase of 23.99% [2] - Zhongwei Semiconductor reported a revenue of 1.122 billion yuan for 2025, a 23.09% increase, and a net profit of 285 million yuan, up 108.05% year-on-year [3] - Sry New Materials achieved a revenue of 1.564 billion yuan in 2025, a growth of 17.66%, with a net profit of 154 million yuan, reflecting a year-on-year increase of 35.04% [14] - Jiaokong Technology reported a revenue of 2.537 billion yuan for 2025, a growth of 16.08%, and a net profit of 156 million yuan, up 86.13% year-on-year [15] - SanSheng Guojian reported a revenue of 4.199 billion yuan for 2025, a significant increase of 251.81%, with a net profit of 2.939 billion yuan, up 317.09% year-on-year [30] Group 2 - Aidi Pharmaceutical reported a revenue of 721 million yuan for 2025, a growth of 72.49%, but incurred a net loss of 19.73 million yuan, reducing losses from 142 million yuan in the previous year [5] - Weidao Nano reported a revenue of 2.632 billion yuan for 2025, a decrease of 2.52%, with a net profit of 213 million yuan, down 6.12% year-on-year [9] - Wens Foodstuff Group reported a revenue of 103.884 billion yuan for 2025, a decline of 1.67%, with a net profit of 5.235 billion yuan, down 43.59% year-on-year [29] - Supor reported a revenue of 22.772 billion yuan for 2025, a growth of 1.54%, with a net profit of 2.097 billion yuan, down 6.58% year-on-year [33] Group 3 - ShaoNeng Co. signed a significant operational contract worth 22 million yuan for a biomass power generation project [6] - Shunlian Bio plans to use 237 million yuan to acquire controlling interest in a joint venture, increasing its stake from 16.99% to 51% [7] - Huason Pharmaceutical's subsidiary received clinical trial approval for an innovative drug, indicating progress in its product pipeline [8] - Xinyang Technology's subsidiary received a medical device registration certificate, enhancing its product offerings [10][11] - Yida Co. obtained an investment project filing certificate for a chemical production project with a total investment of 642 million yuan [12]

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 rivaroxaban tablets, allowing the product to be marketed [1] Group 1: Product Approval - Rivaroxaban tablets are approved for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treating and preventing deep vein thrombosis, treating pulmonary embolism, and preventing venous thromboembolism in acutely ill patients [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Health Sciences Authority (HSA) of Singapore for the marketing of rivaroxaban tablets produced by its subsidiary, Changzhou Pharmaceutical Factory [1] Group 1: Product Information - Rivaroxaban tablets are primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treat and prevent deep vein thrombosis (DVT), treat pulmonary embolism (PE), and prevent venous thromboembolism (VTE) in acutely ill patients [1] - The drug was originally co-developed by BAYER and JANSSEN and was first launched in the United States in 2011 [1] Group 2: Regulatory Approvals - The rivaroxaban tablets received approval from the U.S. Food and Drug Administration (FDA) in May 2025 and obtained a drug registration certificate in Malaysia in October 2025 [1] Group 3: Investment and R&D - As of the date of the announcement, the company has invested approximately RMB 3.2482 million in research and development for the drug's market entry in Southeast Asia, including Thailand, Singapore, Malaysia, and the Philippines [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Health Sciences Authority of Singapore for the marketing of its rivaroxaban tablets, marking a significant step in expanding its overseas market presence [1][2]. Group 1: Product Approval and Market Impact - The rivaroxaban tablets are indicated for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) [1]. - The approval in Singapore is part of a broader strategy to enter Southeast Asian markets, with additional investments of approximately RMB 3.2482 million allocated for research and development related to this product [1]. - The presence of other approved manufacturers in Singapore, including Bayer, Teva, and Intega, indicates a competitive landscape, with Bayer being the primary seller [1]. Group 2: Market Data and Future Prospects - The total sales value of rivaroxaban tablets in Singapore for the year 2024 is projected to be USD 8 million across three specifications (10mg, 15mg, 20mg) [1]. - The approval of rivaroxaban tablets in Singapore is expected to have a positive impact on the company's efforts to expand its overseas market and gain valuable experience [2].

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. * （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利伐沙班片獲得新加坡藥品註冊證書的公告》僅供 參閱。 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 2 月 25 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；職工董事為趙勇先生；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。 证券代码：601607 证券 ...