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復星醫藥：海外監管公告 - 關於控股子公司藥品臨床試驗進展的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement in Relation to the Progress of Drug Clinical Trials by a Subsidiary

香港交易所 ·  Apr 1 06:07
Summary by Moomoo AI
上海復星醫藥（集團）股份有限公司（「復星醫藥」）宣布其控股子公司復紅康合醫藥江蘇有限公司與日本明治制果藥業共同開發的新藥OP0595（通用名：Nacubactam）在中國境內啟動兩項III期臨床試驗。這兩項試驗旨在評估新藥與頭孢吡肟或氨曲南聯合給藥對於治療方案有限的成人需氧革蘭氏陰性菌感染的有效性和安全性。新藥OP0595是一種靜脈滴注的新型β-內酰胺酶抑制劑，目前在中國境內處於I期臨床試驗階段。截至2024年2月，復星醫藥對該新藥的累計研發投入約為人民幣2,663萬元。根據IQVIA MIDAS™最新數據，2022年全球範圍內已获批上市的治療耐藥性革蘭氏陰性菌感染的相關藥物銷售額合計約為50.47億美元。復星醫藥提醒投資者，新藥研發至上市存在諸多不確定因素，並請注意投資風險。
上海復星醫藥（集團）股份有限公司（「復星醫藥」）宣布其控股子公司復紅康合醫藥江蘇有限公司與日本明治制果藥業共同開發的新藥OP0595（通用名：Nacubactam）在中國境內啟動兩項III期臨床試驗。這兩項試驗旨在評估新藥與頭孢吡肟或氨曲南聯合給藥對於治療方案有限的成人需氧革蘭氏陰性菌感染的有效性和安全性。新藥OP0595是一種靜脈滴注的新型β-內酰胺酶抑制劑，目前在中國境內處於I期臨床試驗階段。截至2024年2月，復星醫藥對該新藥的累計研發投入約為人民幣2,663萬元。根據IQVIA MIDAS™最新數據，2022年全球範圍內已获批上市的治療耐藥性革蘭氏陰性菌感染的相關藥物銷售額合計約為50.47億美元。復星醫藥提醒投資者，新藥研發至上市存在諸多不確定因素，並請注意投資風險。
Shanghai Fuxing Pharmaceuticals (Group) Co., Ltd. (“Fuxing Pharmaceuticals”) announced the initiation of two Phase III clinical trials of its new drug OP0595 (generic name: Nacubactam) in China, jointly developed by its holding subsidiary Fuxing Medical Co., Ltd., and Meiji Products Pharmaceuticals of Japan. The two trials were designed to evaluate the efficacy and safety of the new drug in combination with cefepididymim or ammonine for oxygen-negative bacterial infections in adults with limited treatment regimens. The new drug OP0595 is a novel β-enamidase inhibitor for intravenous drip and is currently in Phase I clinical trials in China. As of February 2024, Fustar Pharmaceuticals invested in the cumulative R&D of the new drug of approximately RMB 2,663 million. According to the latest data from IQVIA MIDAS™, total sales of drugs related to the treatment of drug-resistant gonorrhea negative bacterial infections have been approved globally in 2022 for approximately $50.47 billion. Pustar Pharmaceuticals reminds investors that there are many uncertainties surrounding the development of new drugs to market and to be aware of investment risks.
Shanghai Fuxing Pharmaceuticals (Group) Co., Ltd. (“Fuxing Pharmaceuticals”) announced the initiation of two Phase III clinical trials of its new drug OP0595 (generic name: Nacubactam) in China, jointly developed by its holding subsidiary Fuxing Medical Co., Ltd., and Meiji Products Pharmaceuticals of Japan. The two trials were designed to evaluate the efficacy and safety of the new drug in combination with cefepididymim or ammonine for oxygen-negative bacterial infections in adults with limited treatment regimens. The new drug OP0595 is a novel β-enamidase inhibitor for intravenous drip and is currently in Phase I clinical trials in China. As of February 2024, Fustar Pharmaceuticals invested in the cumulative R&D of the new drug of approximately RMB 2,663 million. According to the latest data from IQVIA MIDAS™, total sales of drugs related to the treatment of drug-resistant gonorrhea negative bacterial infections have been approved globally in 2022 for approximately $50.47 billion. Pustar Pharmaceuticals reminds investors that there are many uncertainties surrounding the development of new drugs to market and to be aware of investment risks.
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