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

Hanmi Pharmaceutical's tirzepatide injection receives FDA acceptance for diabetes and weight loss

Hanmi Pharmaceutical has received acceptance from the U.S. FDA for its abbreviated new drug application (ANDA) for tirzepatide injection, targeting diabetes and weight loss. This drug is a dual-target agonist developed by Eli Lilly, known for its significant global sales. Hanmi Pharmaceutical aims to leverage its integrated raw material and formulation capabilities to advance the application, though final approval and first-to-file status remain uncertain. AI

RANK_REASON The item reports on a regulatory filing acceptance for a drug application, which falls under research and development milestones. [lever_c_demoted from research: ic=1 ai=0.4]

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Hanmi Pharmaceutical's tirzepatide injection receives FDA acceptance for diabetes and weight loss

COVERAGE [1]

  1. 36氪 (36Kr) TIER_1 中文(ZH) ·

    Hanyu Pharmaceutical: Two ANDAs for Tirzepatide Injection for Hypoglycemia and Weight Loss Receive First Generic Acceptance from US FDA

    36氪获悉,翰宇药业公告,公司向美国FDA申报的替尔泊肽注射液(降糖及减重适应症)新药简略申请(ANDA)已获受理审查,共6个规格。该药品为礼来研发的GLP-1R/GIPR双靶点激动剂,2025年全球销售额约365.07亿美元。公司于2026年5月13日提交首仿注册申请并提交专利挑战声明,凭借原料药+制剂一体化优势推进申报。目前该ANDA尚处审评阶段,最终获批及首仿资格存在不确定性。