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海正藥業(600267.SH):子公司HS301片(40mg、80mg)獲批開展局部晚期或轉移性實體瘤臨牀試驗
格隆匯 01-25 16:07

格隆匯1月25日丨海正藥業(600267.SH)公佈,近日,浙江海正藥業股份有限公司全資子公司瀚暉製藥有限公司(“瀚暉製藥”)收到國家藥品監督管理局核准簽發的HS301片(40mg、80mg)的《藥物臨牀試驗批准通知書》。

HS301片是第二代口服NTRK/ROS1小分子激酶抑制劑,是一種泛癌種治療藥物,能夠克服多種突變和耐藥,適用於治療含有NTRK1/2/3和ROS1融合陽性的實體瘤。

目前Roche公司的第一代NTRK/ROS1抑制劑恩曲替尼(Entrectinib,商品名Rozlytrek)以及禮來旗下LoxoOncology公司開發的第一代NTRK抑制劑拉羅替尼(Larotrectinib,商品名Vitrakvi)已在美國獲批上市,在中國處於註冊申報階段;第二代NTRK/ROS1抑制劑均未上市。

後續瀚暉製藥將按照上述《藥物臨牀試驗批准通知書》要求進行該品臨牀試驗研究。截至目前,公司在該藥品研發項目上已投入約3221萬元人民幣。

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