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成都先導(688222.SH):1.1類抗腫瘤創新藥HG030項目獲FDA批准開展臨牀試驗
格隆匯 01-24 17:01

格隆匯1月24日丨成都先導(688222.SH)公佈,2022年1月22日,公司自主研發的1.1類抗腫瘤創新藥HG030項目獲得美國食品藥品監督管理局(“FDA”)批准開展臨牀試驗(IND編號:159807)。

HG030是一款二代Trk口服小分子抑制劑,臨牀擬用於一線治療NTRK或ROS1基因融合腫瘤,也可用於攜帶獲得性突變對第一代藥物耐藥的實體瘤患者。

HG030片是成都先導研發的一個擁有自主知識產權的結構全新的激酶抑制劑,已於2021年9月28日獲得國家發明專利授權,已於2020年3月25日獲得國家藥品監督管理局I期臨牀試驗許可。

2020年11月,成都先導將HG030片全部可能的治療領域和適應症在中國大陸(不包括台灣、香港、澳門)的全部權利(包括但不限於專利權、研發、生產、銷售)轉讓給白雲山製藥總廠,由白雲山製藥總廠自行承擔全部費用進行HG030片的後續研發、生產及銷售,成都先導仍保留HG030產品中國大陸以外所有區域的全部權益。

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