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復星醫藥：海外監管公告 - 關於控股子公司獲藥品註冊申請受理的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement in Relation to the Acceptance of a Subsidiary''s Drug Registration Application

Hong Kong Stock Exchange ·  Apr 17 05:45
Summary by Moomoo AI
上海復星醫藥（集團）股份有限公司（簡稱「復星醫藥」）宣布其控股子公司桂林南藥股份有限公司開發的膦甲酸鈉注射液新藥，已於近日獲得國家藥品監督管理局的藥品註冊申請受理。該新藥主要用於治療AIDS患者的CMV視網膜炎以及免疫功能低下患者的耐阿昔洛韋HSV的皮膚黏膜感染。截至2024年3月，復星醫藥對該新藥的研發投入累計約為人民幣417萬元。公司提醒，新藥在商業化生產前還需通過多項審核，包括GMP符合性檢查及獲得藥品註冊批准等，且本次申請受理不會對集團當前業績產生重大影響。復星醫藥強調，由於醫藥產品行業特點，該藥品的銷售情況存在不確定性，投資者應注意投資風險。
上海復星醫藥（集團）股份有限公司（簡稱「復星醫藥」）宣布其控股子公司桂林南藥股份有限公司開發的膦甲酸鈉注射液新藥，已於近日獲得國家藥品監督管理局的藥品註冊申請受理。該新藥主要用於治療AIDS患者的CMV視網膜炎以及免疫功能低下患者的耐阿昔洛韋HSV的皮膚黏膜感染。截至2024年3月，復星醫藥對該新藥的研發投入累計約為人民幣417萬元。公司提醒，新藥在商業化生產前還需通過多項審核，包括GMP符合性檢查及獲得藥品註冊批准等，且本次申請受理不會對集團當前業績產生重大影響。復星醫藥強調，由於醫藥產品行業特點，該藥品的銷售情況存在不確定性，投資者應注意投資風險。
SHANGHAI FUSTAR PHARMACEUTICALS (GROUP) CO., LTD. (“FUSTAR PHARMACEUTICALS”) ANNOUNCED THAT A NEW DRUG FOR INJECTION SODIUM PHOSPHATE, DEVELOPED BY ITS HOLDING SUBSIDIARY GUILIN NANDRUG CO., LTD., HAS RECENTLY RECEIVED A DRUG REGISTRATION APPLICATION FROM THE NATIONAL DRUG ADMINISTRATION. The new drug is mainly used to treat CMV retinitis in AIDS patients and infections of the skin mucosa resistant to acyclovir HSV in immunocompromised patients. As of March 2024, Fustar Pharmaceuticals invested in the research and development of the new drug amounted to approximately RMB417 million. The Company points out that the new drug is subject to a number of audits before commercialization, including GMP compliance checks and drug registration approval, and that the acceptance of this application will not have a significant impact on the Group's current performance. FUSTAR PHARMACEUTICALS EMPHASIZES THAT DUE TO THE CHARACTERISTICS OF THE PHARMACEUTICAL PRODUCT INDUSTRY, THERE IS UNCERTAINTY ABOUT THE SALES OF THIS DRUG, INVESTORS SHOULD BE AWARE OF INVESTMENT RISKS.
SHANGHAI FUSTAR PHARMACEUTICALS (GROUP) CO., LTD. (“FUSTAR PHARMACEUTICALS”) ANNOUNCED THAT A NEW DRUG FOR INJECTION SODIUM PHOSPHATE, DEVELOPED BY ITS HOLDING SUBSIDIARY GUILIN NANDRUG CO., LTD., HAS RECENTLY RECEIVED A DRUG REGISTRATION APPLICATION FROM THE NATIONAL DRUG ADMINISTRATION. The new drug is mainly used to treat CMV retinitis in AIDS patients and infections of the skin mucosa resistant to acyclovir HSV in immunocompromised patients. As of March 2024, Fustar Pharmaceuticals invested in the research and development of the new drug amounted to approximately RMB417 million. The Company points out that the new drug is subject to a number of audits before commercialization, including GMP compliance checks and drug registration approval, and that the acceptance of this application will not have a significant impact on the Group's current performance. FUSTAR PHARMACEUTICALS EMPHASIZES THAT DUE TO THE CHARACTERISTICS OF THE PHARMACEUTICAL PRODUCT INDUSTRY, THERE IS UNCERTAINTY ABOUT THE SALES OF THIS DRUG, INVESTORS SHOULD BE AWARE OF INVESTMENT RISKS.
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