貝達藥業(300558.SZ)披露新藥項目MIL60臨牀試驗進展 III期研究達到主要研究終點
格隆匯12月5日丨貝達藥業(300558.SZ)公佈，12月5日，公司和北京天廣實生物技術股份有限公司(“天廣實”)聯合申辦的“比較MIL60聯合紫杉醇和卡鉑與貝伐珠單抗聯合紫杉醇和卡鉑治療晚期或複發性非鱗狀細胞非小細胞肺癌初治受試者的有效性和安全性的隨機、雙盲、多中心III期研究”達到主要研究終點。
MIL60是公司和天廣實共同開發的重組抗人血管內皮生長因子人源化單克隆抗體，屬於貝伐珠單抗生物類似藥，該藥物可以選擇性地與人血管內皮生長因子(VEGF)結合並阻斷其生物活性，包含人類抗體的框架區以及可結合VEGF的人源化鼠抗體的抗原結合區，可抑制VEGF與其位於內皮細胞上的受體—Flt-1和KDR相結合，通過使VEGF失去生物活性而減少腫瘤的血管形成，從而抑制了腫瘤的生長。貝伐珠單抗原研藥安維汀於2015年7月9日獲得批准，在與卡鉑和紫杉醇聯合應用時，可作為一線治療用於不可切除的晚期、轉移性或複發性非鱗狀細胞非小細胞肺癌患者。
該研究是一項隨機、雙盲、多中心III期臨牀研究，適應症為晚期或複發性非鱗狀細胞非小細胞肺癌，主要研究終點為獨立影像評估委員會(IRC)評估的客觀緩解率(ORR)，由中國醫學科學院腫瘤醫院王潔教授擔任主要研究者，全國共有50家研究中心參與。近日，公司針對本研究開展了療效評估，數據顯示達到主要研究終點。根據2015年原國家食品藥品監督管理總局發佈的《生物類似藥研發與評價技術指導原則(試行)》，MIL60已順利完成上市要求的與貝伐珠單抗原研藥安維汀臨牀前比對研究、臨牀藥代動力學比對研究、以及臨牀III期有效性比對研究。
目前，有關臨牀試驗的總結報告正在整理當中，根據我國藥品註冊相關的法律法規要求，後續將開展申請註冊及申報生產的相關工作，藥品在經國家藥品監督管理局審評、審批通過後方可上市，目前尚不會對公司經營產生影響。公司將按照有關規定及時對項目後續進展情況履行信息披露義務。
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