复星医药(02196.HK)就在研产品HLX10签署许可条款书以加快拓展东南亚市场
格隆汇9月12日丨复星医药(02196.HK)公布,公司控股子公司上海复宏汉霖生物技术股份有限公司就在研产品HLX10(即重组抗PD-1人源化单克隆抗体注射液)拟授予PT Kalbe Genexine Biologics在区域内(即菲律宾、印度尼西亚、马来西亚、新加坡等10个国家,下同)及领域内(即:(1)首个适应症、(2)2个联合疗法适应症、(3)KalbeGenexine依约可选择的其他2个适应症,下同)独家开展商业化的权利及为该等商业化目的而享有相关知识产权的权利等。
HLX10(即重组抗PD-1人源化单克隆抗体注射液)为本集团自主研发的创新型治疗用生物制品,主要用于实体瘤治疗,目前也正进一步探索其治疗慢性乙型肝炎的可能性。截至2019年8月,本集团现阶段针对该新药的累计研发投入为人民币约19,564万元(未经审计)。
截至本公告日,于全球上市的重组抗PD-1人源化单克隆抗体注射液包括默沙东制药有限公司的Keytruda、美国百时美施贵宝公司的Opdivo?等。根据IQVIAMIDASTM最新数据,2018年度,重组抗PD-1人源化单克隆抗体注射液于全球销售额约为143亿美元。
公司称,本次合作旨在通过与区域内商业伙伴的合作,提前规划该新药在区域内的商业化布局,有助于加快该新药在东南亚地区的市场拓展。
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