Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for doxycycline capsules, marking a significant step in expanding its overseas market presence [1] Summary by Categories Company Developments - The company has invested approximately 10.83 million yuan in the research and development of doxycycline capsules as of the announcement date [1] - The approval of the ANDA is expected to provide valuable experience for the company in navigating international markets [1] Market Implications - The approval is seen as a positive development for the company, enhancing its ability to expand into overseas markets [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for the marketing of its rivaroxaban tablets, indicating a significant milestone for the company in expanding its product offerings in international markets [2] Company Summary - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory Co., Ltd., is responsible for the production of the rivaroxaban tablets that have now been registered for sale in Malaysia [2] Industry Summary - The approval of rivaroxaban tablets in Malaysia reflects the growing demand for anticoagulant medications in the Southeast Asian market, highlighting potential growth opportunities for pharmaceutical companies operating in this region [2]

Core Viewpoint - Shanghai Pharmaceuticals announced the approval of its abbreviated new drug application (ANDA) for doxycycline capsules by the U.S. Food and Drug Administration (FDA) [2] Company Summary - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, received notification from the FDA regarding the approval of its ANDA for doxycycline capsules [2]

Core Viewpoint - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for doxycycline capsules, indicating a significant milestone for the company in the U.S. market [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, is the entity that received the FDA notification regarding the approval [1] - The approved doxycycline capsules contain two types of microcapsules: 30mg immediate-release and 10mg delayed-release, targeting inflammatory lesions in adult patients with rosacea [1]

Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) announced a significant equity adjustment involving its actual controller, the Shanghai State-owned Assets Supervision and Administration Commission, which will transfer all shares of Shanghai Industrial (Group) Co., Ltd. to Jinzhong International Holdings Limited [1] Group 1 - Following the equity adjustment, the shareholding of Shanghai Industrial (Group) Co., Ltd. in the company will increase from 25.303% to 38.487% [1] - The equity adjustment will not result in a change of the company's controlling shareholder or actual controller, which will remain the Shanghai State-owned Assets Supervision and Administration Commission [1]

Core Viewpoint - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for Doxycycline Capsules, marking a significant milestone for the company in the U.S. market [1] Group 1: Company Announcement - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has been notified by the U.S. FDA regarding the approval of its ANDA for Doxycycline Capsules [1] - The Doxycycline Capsules (40mg) contain two types of micro-pellets: 30mg immediate-release and 10mg delayed-release, primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories LP and was launched in the U.S. in 2006 [1] Group 2: Financial Investment - As of the date of the announcement, the company has invested approximately RMB 10.83 million in the research and development of this drug [1] - The ANDA application for the drug was submitted to the U.S. FDA in September 2024 and has recently been approved for marketing [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Doxycycline Capsules, indicating a significant milestone for the company in the U.S. market [1] Group 1: Company Announcement - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has successfully obtained FDA approval for Doxycycline Capsules [1] - The drug is primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories LP and was launched in the U.S. in 2006 [1] Group 2: Financial Investment - The company has invested approximately RMB 10.83 million in research and development for this drug as of the announcement date [1] - The Doxycycline Capsules consist of two types of microcapsules: 30mg immediate-release and 10mg delayed-release [1] Group 3: Regulatory Milestone - The ANDA application for Doxycycline was submitted to the FDA in September 2024 and has now been approved [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, which is significant for expanding its overseas market presence and gaining valuable experience [1] Group 1: Product Information - Doxycycline Capsules (40mg) contain two types of microcapsules: 30mg immediate-release and 10mg delayed-release, primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories and was launched in the U.S. in 2006 [1] Group 2: Regulatory Approval - The ANDA application for Doxycycline was submitted to the U.S. FDA in September 2024 and has recently been approved for market entry [1] - The company has invested approximately RMB 10.83 million in research and development for this drug as of the announcement date [1] Group 3: Strategic Implications - The approval of Doxycycline Capsules is expected to positively impact the company's efforts to expand into international markets [1] - This achievement is seen as a way to accumulate valuable experience for future endeavors in the pharmaceutical industry [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for the marketing of its rivaroxaban tablets, indicating a significant step in expanding its market presence in Malaysia [1] Company Summary - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, has obtained a drug registration certificate for rivaroxaban tablets from the NPRA [1] - The approved rivaroxaban tablets are available in three specifications: 10mg, 15mg, and 20mg [1] Industry Summary - Rivaroxaban is primarily used to reduce 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), treatment of pulmonary embolism (PE), and prevention of venous thromboembolism (VTE) in acutely ill patients [1]

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多西環素膠囊獲得美國 FDA 批准文號的公告》、《上 海醫藥集團股份有限公司關於利伐沙班片獲得馬來西亞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，2025 年 10 月 15 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 ...