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復宏漢霖(02696.HK)公佈一項針對HLX04的3期臨試研究結果
格隆匯 08-12 19:53

格隆匯 8 月 12日丨復宏漢霖-B(02696.HK)發佈公告,公司就HLX04(重組抗VEGF人源化單克隆抗體注射液,為貝伐珠單抗的生物類似藥)(“HLX04”)用於轉移性結直腸癌(mCRC)治療已完成3期臨牀研究,且該試驗已達到預設的主要研究終點。

本次研究是一項比較HLX04或原研貝伐珠單抗(以下簡稱“原研藥”)聯合化療方案(XELOX方案或mFOLFOX6方案)一線治療轉移性結直腸癌的隨機、雙盲、多中心、平行對照的3期臨牀研究,旨在比較HLX04與原研藥的有效性、安全性及免疫原性。該研究的主要目的為證明HLX04與原研藥療效的等效性,主要終點為36周時的無進展生存率(PFSR36w);次要目的包括其他比較 HLX04與原研藥有效性的評估,及HLX04與原研藥的安全性、耐受性和免疫原性特徵的比較。

本次研究的主要目的和次要目的均已達到,研究結果表明HLX04用於一線治療轉移性結直腸癌的療效與原研藥等效,其安全性、耐受性、及免疫原性與原研藥相似。

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