君實生物(01877.HK)與全球領先科技公司默克簽署臨牀研究合作及供貨協議
格隆匯6月1日丨君實生物－Ｂ(01877.HK)發佈公告，近日，公司與Merck KGaA(“默克”)簽署了《臨牀研究合作及供貨協議》。根據協議，雙方將在中國共同探索特瑞普利單抗注射液(商品名：拓益*，產品代號：JS001)聯合西妥昔單抗注射液(商品名：愛必妥®)治療復發和 ╱ 或轉移性頭頸部鱗癌的療效和安全性，公司將作為申辦方開展該聯合用藥試驗。
據悉，默克是一家全球領先的科技公司，專注於醫藥健康、生命科學和高性能材料三大領域。全球約有57,000名員工服務於默克，通過創造更加愉悦和可持續性的生活方式，為數百萬人的生活帶來積極的影響。從先進的基因編輯技術和發現治療最具挑戰性疾病的獨特方法，到實現設備的智能化－默克無處不在。2019年，默克在66個國家的總銷售額達162億歐元。
根據披露，西妥昔單抗是全球首個靶向表皮生長因子受體(EGFR)的IgG1單克隆抗體。作為一種單抗藥物，西妥昔單抗與標準的非選擇性化療藥物不同之處在於靶向並結合 EGFR，這種結合抑制了受體激活和下游的信號傳導，從而抑制腫瘤細胞對正常組織的侵襲以及腫瘤向新位點的擴散。此外，西妥昔單抗也能夠抑制腫瘤細胞修復化療和放療所致損傷的能力以及抑制腫瘤內新生血管的形成，從而整體抑制腫瘤生長。基於體外研究證據，西妥昔單抗針對EGFR陽性腫瘤細胞，還具有抗體依賴性細胞介導的細胞毒作用(ADCC)，可發揮抗腫瘤的免疫效應。
截至目前，愛必妥®已獲全球100多個國家╱地區批准，用於治療RAS野生型轉移性結直腸癌(mCRC)和復發和╱或轉移性頭頸部鱗癌(R/M SCCHN)。愛必妥®由 ImClone(現為禮來全資子公司)研製，默克於1998年獲得了愛必妥®除美國和加拿大以外市場的獨家權益。
協議的簽署將有助於進一步拓展特瑞普利單抗注射液所針對的適應症，深化公司臨牀佈局，對公司發展將產生積極影響。
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