復星醫藥(600196.SH)：用於轉移性結直腸癌治療的HLX04已完成III期臨牀研究且已達到預設的主要研究終點
格隆匯 8 月 12日丨復星醫藥(600196.SH)公佈，近日，公司控股子公司上海復宏漢霖生物技術股份有限公司(“復宏漢霖”)研製的重組抗VEGF人源化單克隆抗體注射液(即HLX04，以下簡稱“該新藥”)用於轉移性結直腸癌治療已完成III期臨牀研究，且此次研究已達到預設的主要研究終點。
該新藥為集團自主研發的單克隆抗體生物藥，擬主要用於轉移性結直腸癌適應症、非小細胞肺癌適應症的治療、濕性年齡相關性黃斑變性和糖尿病性視網膜病變適應症的治療。截至公告日，該新藥用於轉移性結直腸癌適應症、非小細胞肺癌適應症治療的藥品註冊申請在籌備中，用於濕性年齡相關性黃斑變性和糖尿病性視網膜病變適應症治療已獲國家藥品監督管理局臨牀試驗批准。
此次研究是一項比較該新藥、原研貝伐珠單抗(“原研藥”)聯合化療方案(XELOX方案、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III期臨牀研究，旨在比較該新藥與原研藥的有效性、安全性及免疫原性。此次研究的主要目的為證明該新藥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該新與原研藥有效性的評估，及該新藥與原研藥的安全性、耐受性和免疫原性特徵的比較。
近日，此次研究的主要目的和次要目的均已達到，研究結果表明該新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。
截至公告日，於中國境內上市的貝伐珠單抗包括Roche Pharma (Schweiz)Ltd.的安維汀®、齊魯製藥有限公司的安可達®、信達生物製藥(蘇州)有限公司的達攸同®。根據IQVIACHPA最新數據(由IQVIA提供，IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商；IQVIACHPA數據代表中國境內100張牀位以上的醫院藥品銷售市場，不同的藥品因其各自銷售渠道佈局的不同，實際銷售情況可能與IQVIACHPA數據存在不同程度的差異)，2019年度，貝伐珠單抗於中國境內的銷售額約為人民幣28.83億元。
截至2020年7月，集團現階段針對該新藥累計研發投入約人民幣46685萬元(未經審計)。
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