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奧賽康(002755.SZ):抗腫瘤生物新藥ASKB589獲批臨牀試驗
格隆匯 07-08 17:34

格隆匯 7 月 8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(“江蘇奧賽康”)及其全資子公司江蘇奧賽康生物醫藥有限公司(“奧賽康生物”)於近日收到國家藥品監督管理ASKB589注射液藥物臨牀試驗批准通知書》。

ASKB589 注射液為江蘇奧賽康自主研發、具有自主知識產權的抗腫瘤生物新藥,其主要通過ADCC CDC殺傷腫瘤細胞,擬用於胃及胃食管結合部腺癌、胰腺癌等適應症。

中國胃癌的發病率和死亡率在所有惡性腫瘤中排名第二,臨牀上發現的胃癌多為局部晚期或晚期,且目前胃癌化療和靶向治療藥物種類及作用均有限。胰腺癌具有惡性程度較高、進展迅速、起病隱匿以及早期症狀不典型等特點,臨牀就診時大部分患者已屬於中晚期。胰腺癌的5 年相對生存率在常見惡性腫瘤中最差,僅為7.2%,且呈逐年惡化的趨勢。目前手術切除依然是胰腺癌患者獲得治愈機會和長期生存的唯一有效方法,以吉西他濱為基礎的藥物化療是晚期胰腺癌最主要的一線治療方式。

江蘇奧賽康、奧賽康生物目前完成了ASKB589 注射液的藥學研究、藥理毒理研究以及臨牀試驗方案設計。現有研究結果表明,ASKB589 注射液與靶點結合具有高度特異性,與化療藥物聯用治療胃及胃食管結合部腺癌、胰腺癌等惡性實體瘤具有良好的開發前景。

目前國內外尚無同類產品獲批上市公司將按國家藥品注冊的相關規定和要求開展臨牀試驗,待臨牀試驗成功後按程序申報生產,如順利通過審批將進一步豐富公司產品線,增強公司市場競爭力。

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