復宏漢霖(02696.HK)HLX10聯合化療用於肺癌治療的3期臨牀研究完成土耳其首例患者給藥
格隆匯4月24日丨復宏漢霖(02696.HK)公佈,近日,公司重組抗PD-1人源化單克隆抗體注射液(HLX10)或安慰劑聯合化療(卡鉑-依託泊苷)在既往未接受過治療的廣泛期小細胞肺癌(ES-SCLC)患者中開展的3期臨牀研究完成土耳其首例患者給藥。
2019年9月,該臨牀研究已於中國境內完成首例患者給藥。該項研究為一項比較HLX10聯合化療(卡鉑-依託泊苷)及安慰劑聯合化療(卡鉑-依託泊苷)在既往未接受過治療的廣泛期小細胞肺癌患者中的隨機、雙盲、國際多中心3期臨牀研究,旨在評估兩組間的臨牀療效、安全性和耐受性。
該候選藥物為公司自主研發的創新型治療用生物製品,擬用於實體瘤治療,目前正進一步探索用於治療慢性B型肝炎(即慢性乙型肝炎)的可能性。
截至本公告日,於全球範圍內上市的靶向PD-1的單克隆抗體藥品包括默沙東製藥有限公司的可瑞達、美國百時美施貴寶公司的歐狄沃、信達生物製藥(蘇州)有限公司的達伯舒等。根據IQVIAMIDASTM提供的資料,2019年度,靶向PD-1的單克隆抗體藥品於全球範圍內的銷售額約為187.41億美元。
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