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東曜藥業-B(01875.HK):TAB014的III期臨牀試驗申請獲FDA許可
格隆匯 02-02 06:07

格隆匯2月2日丨東曜藥業-B(01875.HK)發佈公吿,集團獲得美國食品和藥物管理局(FDA)通知,有關單克隆抗體藥物TAB014(重組人源化抗血管內皮細胞生長因子(VEGF)單克隆抗體)玻璃體注射劑,用於治療濕性(新生血管性)年齡相關性黃斑變性(wAMD)的III期臨牀試驗的新藥臨牀(IND)申請,近期獲得FDA許可。

是次IND申請是通過TAB014在中國進行的I期臨牀試驗數據及相關臨牀文獻資料為依據,直接申請III期臨牀試驗許可(免於II期臨牀試驗)。亦是集團首個於海外提交IND申請並獲許可的項目,對集團邁入國際市場具有重要意義。TAB014的臨牀研究及商業化專項已於2019年底被列入中國國家衞生健康委醫藥衞生科技發展研究中心的重大新藥創制科技重大專項。

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