智通财经APP获悉，1月4日，中国国家药监局药品审评中心（CDE）官网公示，葛兰素史克（GSK.US）申报的1类新药德莫奇单抗（depemokimab）又一项新适应症上市申请获得受理。该药的首个上市申请于今年1月1日获CDE受理。
根据GSK公开资料，depemokimab（GSK3511294）是一款长效IL-5拮抗剂，它具有延长的半衰期，有望实现每6个月注射一次就可控制患者症状。该产品已经在治疗严重哮喘和慢性鼻窦炎伴鼻息肉（CRSwNP）的四项3期临床研究中取得积极结果，这四项试验的结果将用于支持在全球范围内的监管申请递交。
根据中国药物临床试验登记与信息公示平台官网，葛兰素史克已经在中国开展了多项depemokimab的3期临床研究，其中治疗嗜酸性粒细胞表型的重症未控制的成人和青少年哮喘的一项3期临床研究已经完成，针对CRSwNP的两项3期临床研究已经完成招募。在研究中，depemokimab的给药方式为每6个月一次或每26周一次皮下注射。
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