信达生物-B(01801.HK):将安维汀®生物类似药的美国和加拿大商业化权益授权给Coherus公司
格隆汇1月14日丨信达生物-B(01801.HK)宣布,公司与Coherus达成了一项合作协议,将集团的安维汀®(贝伐珠单抗)生物类似药(IBI-305)在美国和加拿大的商业化权益授权给Coherus。Coherus计划于2020年底至2021年初向美国食品药品监督管理局("FDA")递交生物制品许可证申请("BLA"),具体时间取决于FDA审批进展,并在获批后开始商业化销售。IBI-305的新药上市申请已于2019年1月获中国国家药品监督管理局("NMPA")受理,并被授予优先审评状态。根据该协议条款,Coherus还拥有在美国和加拿大开发和商业化集团的美罗华®(利妥昔单抗)生物类似药(IBI-301)的非排他性优先选择权。
根据该协议条款,Coherus将就IBI-305支付集团首付款、里程碑付款4500万美元。另外,基于IBI-305未来的销售情况,Coherus还将支付集团双位数百分比的销售分成。当IBI-301被Coherus优先选择时,其享受的付款条款与IBI-305一致。
IBI-305有望成为对实体瘤患者有效的高品质疗法。Coherus与集团有相似的使命、愿景和价值观,公司很高兴和Coherus一起合作将该产品在美国推广,以惠及更多全球患者。
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