Core Viewpoint - Zhaoke Ophthalmology-B (06622) has received orphan drug designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma, a rare childhood eye cancer, which establishes a clear regulatory pathway for new drug clinical trial applications in the U.S. [1] Group 1: FDA Approval and Market Implications - The orphan drug designation allows Zhaoke Ophthalmology to have exclusive rights in the U.S. market for seven years post-approval of the new drug application, providing significant market protection [1] - The FDA cannot approve any other products based on Mephalan for retinoblastoma indications, even if the formulation is modified [1] Group 2: Strategic Partnerships - Zhaoke Ophthalmology has recently entered into a strategic partnership with FAREVA, a leading French pharmaceutical company, to become a trusted partner for drug manufacturing in China [1]
港股异动 | 兆科眼科-B(06622)盘中涨超9% 兆科眼科美法仑获得美国FDA孤儿药资格认证