澤璟製藥(688266.SH):甲苯磺酸多納非尼片遞交新藥上市申請
格隆匯3月23日丨澤璟製藥(688266.SH)公佈,2020年3月20日,公司自主研發的甲苯磺酸多納非尼片(“多納非尼”)已向國家藥品監督管理局(NMPA)提交了新藥上市申請(NDA),目前等待正式受理中。此前,公司在《蘇州澤璟生物製藥股份有限公司首次公開發行股票並在科創板上市招股説明書》中披露:公司預計於2019年底或2020年初完成多納非尼一線治療晚期肝細胞癌的III期臨牀試驗並於2020年一季度提交NDA。
甲苯磺酸多納非尼片是澤璟製藥開發的口服多靶點、多激酶抑制劑類小分子抗腫瘤藥物,屬於1類新藥,公司擁有獨立的自主知識產權。臨牀前藥理學研究證實,多納非尼既可抑制VEGFR、PDGFR等多種受體酪氨酸激酶的活性,也可直接抑制各種Raf激酶,並抑制下游的Raf/MEK/ERK信號傳導通路,抑制腫瘤細胞增殖和腫瘤血管的形成,發揮多重抑制、多靶點阻斷的抗腫瘤作用。本次新藥上市申請主要是基於甲苯磺酸多納非尼片一線治療晚期肝細胞癌的開放、隨機、平行對照、多中心II/III期臨牀研究(試驗代號ZGDH3)的結果。另外,多納非尼治療晚期結直腸癌和碘難治性分化型甲狀腺癌的III期臨牀研究、以及多納非尼與抗PD-1單抗聯合治療晚期肝細胞癌等多種惡性腫瘤的臨牀研究正在進行之中。
該項新藥上市申請的正式受理時間以及藥品註冊批件取得時間和結果均具有不確定性,敬請廣大投資者謹慎決策,注意防範投資風險。
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