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泽璟制药:注射用ZG006获FDA孤儿药资格认定

Core Viewpoint - Zai Jian Pharmaceutical announced that its investigational product ZG006 has received orphan drug designation from the FDA for the treatment of neuroendocrine cancer, marking it as the first trispecific antibody targeting the DLL3 antigen with potential to be a best-in-class molecule [1] Group 1: Product Development - ZG006 is the first trispecific antibody targeting the DLL3 antigen globally [1] - The orphan drug designation will provide ZG006 with policy support for further research, registration, and commercialization in the U.S. [1] Group 2: Benefits of Orphan Drug Designation - The designation includes benefits such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity [1]