奧賽康(002755.SZ):ASKC852片獲批臨牀試驗
格隆匯6月28日丨奧賽康(002755.SZ)公佈,公司的全資子公司江蘇奧賽康藥業有限公司(“子公司”)於近日收到國家藥品監督管理局(“藥監局”)下發的ASKC852片《藥物臨牀試驗批准通知書》,由子公司申報的ASKC852片已獲臨牀試驗批准。
ASKC852片是註冊分類為1類的創新藥,是全新的小分子免疫調節藥物,通過作用於特定的信號通路,能從多種途徑抑制腫瘤的生長和進展,包括抑制腫瘤的上皮-間質轉化(EMT)和轉移,增強腫瘤微環境內的抗腫瘤免疫反應,抑制腫瘤內血管新生等。臨牀前研究發現ASKC852片單藥即能體現抑瘤作用,與PD-1/L1抗體聯用表現出顯著的協同抗腫瘤效果,另外還能有效地抑制癌細胞的轉移。
我國惡性腫瘤的疾病負擔沉重,目前應用最為廣泛的化療、靶向治療和免疫治療均存在相當的侷限性。化療對腫瘤細胞和正常組織細胞無差別殺傷,副作用巨大;靶向治療僅針對特定的基因突變患者,而且治療後較易出現耐藥現象;免疫治療的響應率較低,大部分患者無應答。因此,惡性腫瘤患者仍存在巨大的未滿足的臨牀需求。ASKC852片與現有的治療方法聯用,有望通過激活免疫系統、抑制腫瘤細胞遷移,進一步延長瘤患者的生存期,目前國內外尚無同類品種上市,市場前景廣闊。
根據我國藥品註冊相關的法律法規要求,新藥在獲得藥物臨牀試驗準通知書後,即可以開展臨牀試驗,臨牀試驗獲得成功後可註冊申報生產,經國家藥監局審評、審批通過後方可生產上市。如果ASKC852片最終研發成功,將與公司現有豐富的抗腫瘤品種配合,進一步豐富公司的創新藥管線,增強公司的市場競爭力。
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