智通财经APP获悉，百济神州(06160)再涨超6%，截至发稿，涨6.28%，报176.1港元，成交额4.26亿港元。
消息面上，7月16日，国家药品监督管理局(NMPA)药品审评中心(CDE)网站显示，百济神州的注射用塔拉妥单抗(tarlatamab)上市申报获受理。此前，该药物已被纳入优先审评程序，拟用于既往接受过至少二线治疗(包括含铂化疗)失败的广泛期小细胞肺癌(ES-SCLC)成人患者的治疗。塔拉妥单抗作为同类首创(First-in-class)的DLL3/CD3双特异性抗体，或将为小细胞肺癌(SCLC)患者的后线治疗带来突破性进展。
据悉，塔拉妥单抗由安进公司研发。百济神州已经与安进公司达成全球肿瘤战略合作，共同推进其在中国的开发和商业化，其中就包括参与全球DeLLphi-304研究和主导塔拉妥单抗用于中国三线及后线患者治疗的DeLLphi–307临床研究，两项研究目前均已取得积极结果。此外，还有多项临床试验正在开展，覆盖SCLC全线治疗人群。未来，双方将继续拓展塔拉妥单抗的应用范围，加速更多适应症申报上市。
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