智通财经APP获悉，亚盛医药-B(06855)盘中涨超4%，截至发稿，涨4.55%，报40.25港元，成交额5269.94万港元。
消息面上，亚盛医药-B发布公告，公司原创1类新药奥雷巴替尼(商品名：耐立克®)获国家药品监督管理局(NMPA)药品审评中心(CDE)纳入“突破性治疗品种”名单，用于联合化疗一线治疗新诊断费城染色体阳性(Ph+)急性淋巴细胞白血病(ALL)患者。
据悉，这是耐立克®第三次获CDE纳入突破性治疗品种。此前，该品种分别于2021年3月和2023年6月获纳入突破性治疗品种，用于治疗一代和二代酪氨酸激酶抑制剂(TKI)耐药和/或不耐受的慢性期慢性髓性白血病(CML-CP)患者;及既往经过一线治疗的琥珀酸脱氢酶(succinate dehydrogenase, SDH)缺陷型胃肠道间质瘤(GIST)患者。
耐立克®是亚盛医药原创1类新药，为中国首个获批上市的第三代BCR-ABL抑制剂。其在中国的商业化推广由亚盛医药和信达生物制药共同负责。截止本公告日期，耐立克®已在中国获批的适应症为：治疗任何TKI耐药、并伴有T315I突变的CML慢性期(-CP)和加速期(-AP)的成年患者；以及治疗对一代和二代TKI耐药和/或不耐受的CML-CP成年患者，且所有获批适应症均已被纳入国家医保药品目录。
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