澤璟製藥(688266.SH)抗腫瘤藥物獲臨牀試驗通知書
格隆匯4月30日丨澤璟製藥(688266.SH)公佈,公司於近日收到國家藥監局核准簽發的《臨牀試驗通知書》。
本次獲批開展甲苯磺酸多納非尼片與基石藥業(蘇州)有限公司的抗PD-L1單克隆抗體CS1001聯合治療晚期實體瘤受試者的多中心、開放性、劑量探索和劑量擴展的Ⅰ/Ⅱ期臨牀研究。根據《Clinical Development Success Rates 2006-2015》公佈的數據,對於抗腫瘤藥物,一般I/II期臨牀研究階段持續約2年時間,I期完成進入II期的比率約62.8%,II期完成進入III期的比率約24.6%。
甲苯磺酸多納非尼片(以下簡稱“多納非尼”)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。多納非尼首次提交臨牀試驗申請獲得受理的時間是2011年10月,多納非尼一線治療晚期肝癌的III期臨牀已經完成並遞交新藥上市申請。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。
CS1001是由基石藥業(蘇州)有限公司自主研發的在研抗PD-L1單克隆抗體,是一種全人源全長抗PD-L1單克隆抗體。CS1001已在中國完成I期臨牀研究劑量爬坡。目前,CS1001正在進行多項臨牀試驗。除了一項美國橋接性I期試驗外,在中國,CS1001正針對多個癌種開展一項多臂Ib期臨牀試驗、兩項II期臨牀試驗和四項III期臨牀試驗。
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