安科生物:PA3-17注射液预计2027年一季度递交pre-NDA沟通交流申请

Core Viewpoint - Anke Bio (300009) announced that its affiliate, Boshengji, has included the PA3-17 injection in the breakthrough therapy category and has entered the critical Phase II clinical trials, aiming to complete patient enrollment within one year and submit a pre-NDA communication request by Q1 2027 [1] Group 1: Clinical Development - The PA3-17 injection has been classified as a breakthrough therapy and is currently in Phase II clinical trials [1] - The company aims to complete the enrollment of all patients within one year [1] - A pre-NDA communication request is expected to be submitted by Q1 2027 [1] Group 2: Indication Expansion - The company is currently submitting an application for pediatric indications [1] - Following the approval for T-ALL/LBL indications, Boshengji plans to expand into other indications, including peripheral T-cell lymphoma, NKT lymphoma, and acute myeloid leukemia [1]