复宏汉霖-B(02696.HK)向Accord US授予HLX02注射用曲妥珠单抗于美国和加拿大独家开发与商业化权益
格隆汇9月30日丨复宏汉霖-B(02696.HK)公布,公司已于近日与Accord Healthcare Inc. (Accord US) 订立一份具约束力条款概要,据此,公司同意向Accord US授予一项许可,供其于美国及加拿大开发及商业化HLX02注射用曲妥珠单抗(中国境内商品名:汉曲优;欧盟商品名:Zercepac)。
许可产品在区域内的许可总里程碑付款包括:首付款2700万美元,于签署用于规范该安排的正式协议后支付;监管里程碑付款合计不超过1300万美元,根据许可产品在美国内的药物代谢动力学研究进度及上市申请进度支付;及于区域内许可产品商业化后,商业销售里程碑付款2500万美元,于许可产品在区域内每取得5亿美元的累计净销售额时支付。被许可方亦将根据许可产品年度净利润的水准向许可方支付许可产品净利润的18%至50%的分层特许权使用费。
截至本公告日期,公司已与多个合作伙伴(包括Accord Healthcare Limited、雅各臣药业(香港)有限公司、Cipla Limited及Mabxience Research,S.L.)就HLX02订立许可及商业化协议,以便成功于中国境外(包括中国香港、中国澳门、马来西亚、澳洲、纽西兰、哥伦比亚、阿根廷、乌拉圭、巴拉圭,以及欧洲、中东-北非及独联体等80多个司法权区及地区)进行HLX02的商业化。
据悉,Accord US与Accord Healthcare Limited(集团就HLX02注射用曲妥珠单抗于欧盟等地区的合作伙伴)同为Intas的附属公司。Accord US于2005年在美国注册成立,专注于医院市场领域,且聚焦于肿瘤学、中枢神经和其他重症监护领域,目前已获得129项仿制药批准。Intas成立于1976年,总部位于印度,主要从事全球范围内的药物制剂成品、活性药物成分、医疗器械和医疗用品的制造、营销、分销及销售。
公司表示,集团已就HLX02注射用曲妥珠单抗于欧盟等地区商业化与Accord Healthcare Limited建立良好合作关系。本次与Accord US就HLX02注射用曲妥珠单抗于美国和加拿大的商业化合作将有助于进一步推进HLX02注射用曲妥珠单抗海外市场拓展,并加强集团产品的可及性和国际影响力。
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