千紅製藥(002550.SZ):ZHB202注射液獲臨牀試驗通知書
格隆匯11月5日丨千紅製藥(002550.SZ)公佈,近日,由公司控股子公司江蘇眾紅生物工程創藥研究院有限公司(以下簡稱:眾紅生物)與千紅製藥聯合申請的一類新藥ZHB202注射液(以下簡稱:ZHB202)獲得國家藥品監督管理局頒發的臨牀試驗通知書。
ZHB202注射液是眾紅生物、千紅製藥歷經七年聯合開發的化學藥品一類創新藥,臨牀適應症為急性淋巴細胞白血病(ALL)、NK/T細胞淋巴瘤。ZHB202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。
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,ZHB202完成了原料藥以及製劑臨牀前的藥學、藥效、藥理、毒理、安全評價等研究。各項試驗結果顯示,ZHB202注射液具有靶嚮明確、作用機制清楚、安全性高等特點。
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