复宏汉霖-B(02696.HK)就HLX35与BINACEA订立许可及共同开发协议 商业里程碑款项合计不超6.7亿美元
格隆汇11月25日丨复宏汉霖-B(02696.HK)公布，公司已于2020年11月25日与Binacea pharma Inc.订立许可及共同开发协议，据此，公司同意基于相关知识产权，就HLX35（公司自主研发的针对EGFR和4-1BB双靶点的双特异性抗体）向Binacea授出一项许可，供其于除中国大陆、香港特别行政区、澳门特别行政区及台湾地区以外的全球范围就所有与任何适应症相关的疾病或失调的人类的治疗、预防、治愈或管理内研究、开发、生产及商业化许可产品。
倘HLX35于美国、欧盟或日本完成1期临床试验，Binacea将有权将许可产品的相关知识产权进行再许可，以持续开发许可产品，前提是相关的再许可被许可方同意遵守Binacea于协议项下的责任。
公司将负责许可产品的临床前研究。订约方协定，公司与Binacea将各自按50%的比例承担因公司进行临床前研究而产生的成本及开支。Binacea将负责HLX35在许可区域及许可领域内的临床研究、监管备案、生产及商业化。公司及Binacea亦同意共同开发经双方书面同意的其他初期研究产品。
Binacea将向公司支付：(a)有关HLX35的首付款500万美元；(b)监管里程碑款项合计不超过9300万美元，基于许可区域内各项注册进展支付；(c)商业里程碑款项合计不超过6.7亿美元，基于许可区域内许可产品的年度净销售额支付；(d)以净销售额的8%到10%计的特许权使用费，具体取决于许可区域内许可产品的净销售额水平。
据悉，HLX35是公司自主研发的针对EGFR（表皮细胞生长因子受体）与4-1BB（即CD137，属肿瘤坏死因子受体家族的成员）双靶点的双特异性抗体。根据临床前的动物实验数据显示，双抗抗体药可有效将两个靶点的优势合并在一起，可以结合在肿瘤表面的EGFR分子上，阻断肿瘤信号传导通路，杀死肿瘤细胞；同时还可以结合免疫细胞（T细胞和NK细胞）表面上的4-1BB免疫激活分子，使更多的免疫细胞聚集在肿瘤周围，并刺激微环境中免疫细胞的活性，从而协同杀死肿瘤细胞，提高疗效。HLX35拟广泛用于治疗结直肠癌和头颈部肿瘤及其他实体肿瘤治疗领域。
Binacea为一家于2020年2月在开曼群岛注册成立的有限公司，其董事会主席为Weijun Feng先生。Binacea主要从事双特异性抗体、多特异性抗体和融合蛋白的研究、开发及销售。
公司表示，本次与Binacea合作将有利于推进公司双特异性抗体产品的研发进展，并通过共同开发和权利许可的方式扩大集团创新产品的可及性和国际影响力。
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