澤璟製藥(688266.SH):抗腫瘤新藥註冊申請獲受理
格隆匯5月11日丨澤璟製藥(688266.SH)公佈,2020年5月11日,公司收到國家藥品監督管理局(NMPA)下發的國家1類新藥甲苯磺酸多納非尼片(以下簡稱“多納非尼”)新藥上市申請(NDA)的《受理通知書》。
甲苯磺酸多納非尼片是公司開發的口服多靶點、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,用於治療晚期(無法手術或轉移性)肝細胞癌。同時,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、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。
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