Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622), has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare childhood eye cancer [1] Regulatory Pathway - Obtaining ODD establishes a clear regulatory pathway for the company to submit a New Drug Application (NDA) in the United States [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. following the NDA approval [1] Market Exclusivity - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity rights [1] - Importantly, even if the formulation is innovated, the FDA cannot approve any other RB indication products based on Mephalan [1]
兆科眼科-B(06622)：用于治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认证