賽升藥業(300485.SZ):人用單克隆抗體K3完成I期臨牀研究試驗
格隆匯12月25日丨賽升藥業(300485.SZ)公佈,近日,公司人用單克隆抗體K3(阿達木單抗注射液)完成I期臨牀研究試驗。
抗人腫瘤壞死因子-α單克隆抗體注射液,為阿達木單抗注射液(商品名:修美樂,Humira)的生物類似藥;單抗輕鏈、重鏈的一級結構與阿達木單抗的完全一致,K3單抗注射液成品質量標準與阿達木單抗的成品檢驗標準相同。
K3單抗採用CHOK1細胞表達,所使用的培養基為化學成分限定的培養基,不含動物、植物來源的蛋白質。主要用於自身免疫性疾病如類風濕性關節炎、斑塊型銀屑病、強直性脊柱炎、潰瘍性結直腸炎等疾病的治療。
2019年07月24日,公司與北京綠竹生物技術股份有限公司簽署技術轉讓協議,約定人用單克隆抗體K3(阿達木單抗注射液)相關技術轉讓給公司。藥物臨牀試驗批件號:2017L04948。
該試驗採用單中心、隨機、盲法、單次給藥、平行對照試驗設計方法。試驗期間試驗藥與參照藥的不良事件發生率相似;無導致受試者退出的不良事件。受試者在該試驗給藥劑量下安全性和耐受性良好。等效性統計分析結果顯示:試驗藥與參照藥的藥代動力學相似。試驗期間試驗藥與參照藥的抗藥抗體和中和性抗藥抗體轉陽性率相似,平均抗體滴度相似。根據《藥品註冊管理辦法》的相關規定,後續將進入III期臨牀試驗並申報經國家藥品監督管理局審評、審批獲得生產批件後方可生產上市。
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