FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年2月28日 狀態: 新提交 II. 已發行股份及/或庫存股份變動及足夠公眾持股量的確認 致：香港交易及結算所有限公司 公司名稱: 上海醫藥集團股份有限公司 呈交日期: 2026年3月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02607 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 919,072,704 | RMB | | 1 RMB | | 919,072,704 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 919,072,704 | RMB | | 1 RMB | | 919,072,70 ...

Group 1 - The core point of the announcement is that Shanghai Pharmaceuticals 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][4]. Group 2 - The drug is named Pregabalin capsules, available in dosages of 50mg, 75mg, and 150mg, and is classified as a chemical generic drug [1]. - 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]. Group 3 - The development of Pregabalin capsules was completed by Changzhou Pharmaceutical Factory in October 2019, and the product received FDA approval in the United States in July 2021. It also obtained drug registration certificates in Thailand in June 2025 and Singapore in January 2026 [2]. Group 4 - As of the end of 2024, there are 19 distributors of Pregabalin capsules in the Philippines, including UNILAB, VIATRIS INC, and NATRAPHARM. The total sales amount for the three dosages in the Philippines market is projected to be $13.37 million [3].

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Philippines Food and Drug Administration for the marketing of its pregabalin capsules, indicating a significant milestone for the company in expanding its product offerings in international markets [1] Group 1 - The company announced that its subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., has successfully obtained a drug registration certificate for pregabalin capsules [1] - The approval marks a key step in the company's strategy to enhance its presence in the pharmaceutical market of the Philippines [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 [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 development for Pregabalin capsules was completed by Changzhou Pharmaceutical Factory in October 2019 [1] Group 2: Regulatory Approvals Timeline - The Pregabalin capsules received approval from the U.S. Food and Drug Administration in July 2021 [1] - The product obtained a drug registration certificate in Thailand in June 2025 and in Singapore in January 2026 [1] Group 3: Investment in R&D - The company has invested approximately RMB 2.19 million in research and development for the product's market entry in Southeast Asia, which includes Thailand, Singapore, Malaysia, and the Philippines [1]

Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) has received approval from the Philippines Food and Drug Administration for the marketing of Pregabalin capsules produced by its subsidiary, Changzhou Pharmaceutical Factory [1] Group 1: Product Approval - The Pregabalin capsules are 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]

（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菲律賓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 28 日 上 海 醫 藥 集 團 股 份 有 限 公 司 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。 Shanghai Pharmaceuticals Holding Co., Ltd. * （於中華人民共和國註冊成立的股份有限公司） 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（ ...

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]

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].