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科倫藥業(002422.SZ):”注射用SKB264“獲得FDA批准臨牀試驗通知
格隆匯 08-23 17:42

格隆匯8月23日丨科倫藥業(002422.SZ)公佈,公司於今日獲悉,公司控股子公司KLUS PHARMA INC.收到美國食品藥品監督管理局(FDA)簽發的書面通知,允許“注射用SKB264”抗體偶聯藥物(Antibody Drug Conjugate,ADC)在美國開展藥物臨牀試驗。

藥品名稱為注射用SKB264;劑型為注射劑;審評結論:KLUS PHARMA INC.可以在美國開展本品臨牀試驗。

2019年7月23日,公司控股子公司KLUS PHARMA INC.向FDA提交“注射用SKB264”的臨牀試驗申請並獲受理,2019年8月23日獲得FDA批准開展臨牀試驗。本品是繼“注射用A166”(HER-2ADC)後,又一個獲得FDA批准開展臨牀試驗的創新ADC藥物。

“注射用SKB264”是靶向人滋養層細胞表面抗原2(TROP-2,在多種上皮來源腫瘤中高表達)的ADC藥物,其偶聯方式和毒素小分子具有自主知識產權,擬用於惡性腫瘤治療。“注射用SKB264”通過新型偶聯方式實現高毒素負載,工藝穩定可控、易於放大,產品批間一致性好。非臨牀研究數據表明在TROP-2陽性的乳腺癌、胃癌、肺癌和結直腸癌動物模型中的抗腫瘤活性顯著,兼具良好的安全性和耐受性。目前全球尚無同靶點的藥物上市。

截至目前,公司在“注射用SKB264”項目上已投入研發費用約2500萬元人民幣。

根據FDA相關法律法規的要求,藥物在開展臨牀試驗後,需定期向FDA彙報試驗結果,並在最終上市前接受FDA的審評和現場核查,通過之後方可生產上市。

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