智通财经APP获悉，维立志博-B(09887)早盘涨超4%，截至发稿，涨3.21%，报64.35港元，成交额897.51万港元。
消息面上，5月19日，维立志博-B发布公告，中华人民共和国国家药品监督管理局(NMPA)药品审评中心(CDE)已批准开展评价维利信™(PD-L1/4-1BB双特异性抗体奥帕替苏米单抗， LBL-024)联合含铂化疗作为一线治疗在晚期肺外神经内分泌癌患者中的确证性III期临床研究。
此次获批标志着奥帕替苏米单抗针对EP-NEC的临床开发成功从后线单药治疗推向一线联合治疗—此前奥帕替苏米单抗已获CDE批准开展单臂关键注册临床研究，用于三线及以上EP-NEC患者；而此次一线III期研究的获批，将奥帕替苏米单抗在EP-NEC领域的适用人群进一步扩大，为该癌种的治疗格局带来根本性重塑。
本次开展的随机、双盲、多中心III期临床研究由北京肿瘤医院的沈琳教授牵头，正在全国多家医院同步推进。该研究获批是基于奥帕替苏米单抗在Ib/II期概念验证性研究中所展现的突破性疗效与良好安全性。该研究已顺利完成概念验证性试验，详细结果计划于今年ESMO大会公布。
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