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復星醫藥(600196.SH):OP0595與頭孢吡肟或氨曲南聯合給藥,針對治療方案有限的成人需氧革蘭氏陰性菌感染於中國境內處於 I 期臨牀試驗階段

格隆匯3月29日丨復星醫藥(600196.SH)公佈,公司控股子公司復紅康合醫藥江蘇有限公司與日本 Meiji Seika Pharma 株式會社(以下簡稱“明治制果藥業”)在區域內(即中國境內、香港及澳門特別行政區)共同開發的 OP0595(通用名:Nacubactam;以下簡稱“該新藥”)與頭孢吡肟或氨曲南聯合給藥,針對治療方案有限的成人需氧革蘭氏陰性菌感染於中國境內(不包括港澳台地區,下同)於近期啟動兩項 III 期臨牀試驗,包括(1)一項評價頭孢吡肟/該新藥或氨曲南/該新藥與亞胺培南/西司他丁相比在治療成人複雜性尿路感染或急性單純性腎盂腎炎中的有效性和安全性的 III 期臨牀試驗,和(2)一項評估頭孢吡肟/該新藥和氨曲南/該新藥與現有最佳治療方法相比在治療成人因耐碳青黴烯腸桿菌引起的複雜性尿路感染、急性單純性腎盂腎炎、醫院獲得性細菌性肺炎、呼吸機相關性細菌性肺炎和複雜性腹腔感染的有效性和安全性的 III 期臨牀試驗。

該新藥是在研靜脈滴注新型β-內酰胺酶抑制劑,擬用於治療方案有限的成人需氧革蘭氏陰性菌感染,包括因耐碳青黴烯腸桿菌引起的感染等。截至本公吿日,該新藥與頭孢吡肟或氨曲南聯合給藥,針對治療方案有限的成人需氧革蘭氏陰性菌感染於中國境內處於 I 期臨牀試驗階段。本次啟動的兩項 III期臨牀試驗均為明治制果藥業就該新藥開展的國際多中心臨牀試驗之部分。

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