君實生物(688180.SH):注射用JS107臨牀試驗申請獲批
格隆匯3月11日丨君實生物(688180.SH)公佈,近日,上海君實生物醫藥科技股份有限公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,注射用JS107(項目代號“JS107”)的臨牀試驗申請獲得批准。
JS107是由公司自主研發的注射用重組人源化抗 Claudin18.2單克隆抗體MMAE(Monomethyl auristatin E)偶聯劑,是靶向腫瘤相關蛋白Claudin18.2的抗體偶聯藥物(ADCs),擬用於治療胃癌和胰腺癌等晚期惡性腫瘤。
JS107可以與腫瘤細胞表面的Claudin18.2結合,通過內吞作用進入腫瘤細胞內,釋放小分子毒素MMAE,對腫瘤細胞產生強大的殺傷力。JS107還保留了抗體依賴性細胞毒性(ADCC)及補體依賴性細胞毒性(CDC)效應,進一步殺傷腫瘤細胞。並且由於MMAE的細胞通透性,JS107能夠通過旁觀者效應介導對其它腫瘤細胞的無差別殺傷,從而提高療效並抑制腫瘤復發。臨牀前體內藥效試驗顯示,JS107具有顯著的抑瘤效果。此外,動物對JS107的耐受性良好,JS107表現出較好的安全性。
此前,公司自主研發的重組人源化抗Claudin18.2單克隆抗體JS012注射液已於2021年11月獲得國家藥監局批准開展臨牀試驗。截至公吿披露日,國內外尚無同類靶點產品獲批上市。
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