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千紅製藥(002550.SZ):“ZHB206注射液”臨牀試驗申請獲受理
格隆匯 04-22 15:42

格隆匯4月22日丨千紅製藥(002550.SZ)公佈,近日,公司及控股子公司江蘇眾紅生物工程創藥研究院有限公司(眾紅生物)收到國家藥品監督管理局核准簽發的受理通知書,“ZHB206注射液”臨牀試驗申請獲得受理。

ZHB206注射液是由公司及控股子公司眾紅生物聯合開發的化學藥品一類創新藥,是用於急性缺血性腦卒中的長效治療藥物。ZHB206注射液相關核心技術目前已申請PCT專利和中國發明專利,具有自主知識產權。

眾紅生物按照化學藥品新註冊分類中一類化藥的相關注冊法規要求,已經完成ZHB206注射液原料藥以及製劑的藥學、藥理毒理、非臨牀安全性評價等研究,各項研究結果表明ZHB206注射液具有安全有效、質量可控、使用便捷等特點。

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