澤璟製藥(688266.SH)獲批開展的多納非尼聯合特瑞普利單抗注射液治療晚期膽管癌患者的安全性和有效性I/II期臨牀研究
格隆匯3月3日丨澤璟製藥(688266.SH)公佈，公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《臨牀試驗通知書》。
此次獲批開展的甲苯磺酸多納非尼片聯合特瑞普利單抗注射液治療晚期膽管癌患者的安全性和有效性I/II期臨牀研究，屬於本品和抗PD-1抗體藥物聯合用藥在晚期膽管癌患者中的安全性和有效性的早期探索性研究。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%。由於藥品的研發週期長、審批環節多、研發投入大，容易受到一些不確定性因素的影響，敬請廣大投資者謹慎決策，注意防範投資風險。
甲苯磺酸多納非尼片(“多納非尼”)是公司自主研發的多靶點激酶抑制劑1類化學新藥，具有雙重的抗腫瘤作用：既可抑制絲氨酸-蘇氨酸激酶(Raf/MEK/ERK)信號傳導通路而直接抑制腫瘤細胞的增殖，還可通過抑制VEGFR和PDGFR而阻斷腫瘤新生血管的形成,間接地抑制腫瘤細胞的生長。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，預計將於2020年第一季度申報新藥上市申請(NDA)；同時，多納非尼針對局部晚期/轉移性放射性碘難治性分化型甲狀腺癌和晚期結直腸癌的III期臨牀、晚期鼻咽癌和晚期胃癌的Ib期臨牀和複發性急性髓系白血病I期臨牀等多個適應症的臨牀試驗正在進行中。
特瑞普利單抗注射液是上海君實生物醫藥科技股份有限公司研發的重組人源化抗PD-1單克隆抗體注射液，於2018年12月17日獲得國家藥監局(NMPA)批准在中國上市銷售，用於既往標準治療失敗後的局部進展或轉移性黑色素瘤。
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