翰宇药业(300199.SZ)：替尔泊肽注射液降糖及减重2个ANDA获得美国FDA首仿受理

智通财经06-30

智通财经APP讯，翰宇药业(300199.SZ)发布公告，近日，公司向美国食品药品监督管理局(以下简称“FDA”)申报的替尔泊肽注射液(Tirzepatide Injection)新药简略申请(ANDA)已获得FDA的受理审查通知。FDA已初步认定该ANDA 基本完整，予以受理审查。替尔泊肽是礼来公司研发的GLP-1R/GIPR双靶点激动剂，在全球减重及降糖药物市场中占据重要地位，全球尚无仿制药...

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