复宏汉霖-B(02696.HK)同意于东南亚就HLX10若干适应症向KG Bio授出开发及商业化的独家许可
格隆汇9月12日丨复宏汉霖-B(02696.HK)宣布,于2019年9月12日,公司与KG Bio订立具约束力的条款概要,据此,公司同意于特定地区内就HLX10若干适应症向KG Bio授出开发及商业化的独家许可。特定地区包括菲律宾、印尼、马来西亚、新加坡、泰国、老挝、缅甸、柬埔寨、文莱及越南。
HLX10是公司正在开发的一种重组抗PD-1人源化单克隆抗体,旨在治疗实体瘤和血液肿瘤。于公告日期,公司已就HLX10在美国、台湾及中国大陆获得新药临床试验申请批准,并已在中国大陆启动HLX10单药疗法的2期临床试验。公司亦正在探索开发HLX10用于治疗乙肝病毒的可能性,并已就乙肝病毒适应症获得食药署的新药临床试验申请批准。此外,HLX10+化疗(顺铂+5-氟尿嘧啶)联合疗法正在进行针对晚期mESCC的3期临床试验,而HLX10+化疗(卡铂+Nab-紫杉醇)正在进行针对晚期sqNSCLC的3期临床试验。
公司具有在产品获批上市前与全球领先的医药公司建立战略商业化合作的丰富经验。公司相信与KGBio的合作将让我们能够透过KGBio既有的能力和资源迅速占有地方市场份额。此外,订立合作安排亦证明了合作夥伴对HLX10市场机会潜力的认可。
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