智通财经APP获悉,诺诚健华(09969)涨超15%,截至发稿,涨15.06%,报10.16港元,成交额4.21亿港元。
消息面上,诺诚健华近日宣布,中国国家药品监督管理局(NMPA)药品审评中心(CDE)已受理新一代泛TRK抑制剂Zurletrectinib(ICP-723)用于治疗携带 NTRK融合基因的晚期实体瘤成人和青少年(12周岁≤年龄<18周岁)患者的新药上市申请(NDA)。Zurletrectinib是诺诚健华自主研发的泛TRK抑制剂,不仅能够有效抑制 TRKA、TRKB、TRKC,而且能够有效抑制TRKA的耐药性突变G595R和 G667C等,可以克服第一代TRK抑制剂的获得性耐药。
太平洋证券指出,公司未来12个月内公司催化剂丰富。血液瘤领域,1)奥布替尼1LCLL/SLL获批上市,坦昔妥单抗r/r DLBCL获批上市;2)ICP-248(BCL2)用于BTKi经治的r/r NHL临床、联合奥布替尼治疗1LCLL/SLL的2期临床的长期疗效数据读出;联合奥布替尼治疗1LCLL/SLL的3期临床完成入组,BTKi经治的r/r MCL注册性临床启动。自免领域,1)奥布替尼ITP 3期完成患者入组,PPMS和SPMS全球3期启动并完成首例患者入组,SLE 2b期25Q4数据读出;2)ICP-332(TYK2 JH1)特应性皮炎3期临床试验、白癜风2期临床试验完成患者入组;3)ICP-488(TYK2 JH2)银屑病3期临床试验完成患者入组。
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