兆科眼科-B：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

Core Viewpoint - The company has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare pediatric eye cancer [1] Group 1 - The ODD provides 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] - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity, ensuring that the FDA cannot approve any other RB indication products based on Mephalan, even if the formulation is modified [1]