博安生物-B(06955.HK):創新抗體偶聯藥物注射用BA1301在中國獲批進行臨牀試驗
格隆匯1月9日丨博安生物-B(06955.HK)宣佈,集團自主開發的抗體偶聯藥物(Antibody-drug conjugate,ADC)注射用BA1301已獲中國國家藥品監督管理局藥品審評中心批准進行臨牀試驗,用於治療Claudin 18.2表達的晚期實體瘤。
注射用BA1301是集團首個靶向Claudin 18.2的新型抗體偶聯藥物,採用定點偶聯技術將小分子細胞毒素與靶向Claudin 18.2的單抗偶聯。該藥品通過抗體的靶向性引導小分子毒素到達腫瘤部位,發揮殺傷腫瘤效果的同時,降低小分子毒素的毒副作用,提高治療的窗口效應。
已完成的臨牀前藥效試驗結果顯示:注射用BA1301具有優異的內化活性和旁殺效果;在不同Claudin 18.2表達水平的腫瘤細胞模型上均展示優異的體內外腫瘤生長抑制效果。已完成的臨牀前藥代動力學、毒理學研究結果顯示:注射用BA1301的小分子毒素基本未見脱落,在動物體內具有良好的安全性和耐受性。
注射用BA1301有望改善Claudin 18.2表達的胃腺癌╱胃食管結合部腺癌、胰腺癌及其他腫瘤的治療效果,為患者提供新的治療選擇。公司相信,基於胃癌和胰腺癌患者的巨大臨牀需求,注射用BA1301將具有廣闊的市場前景。
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