Zhaoke Ophthalmology Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation $(ODD)$ to its proprietary formulation of melphalan for the treatment of pediatric retinoblastoma, a rare pediatric eye cancer. This designation provides a clear regulatory pathway toward the submission of an Investigational New Drug $(IND.AU)$ application in the U.S. If successfully developed and approved, Zhaoke Ophthalmology Ltd. would be eligible for seven years of market exclusivity in the U.S. upon New Drug Application (NDA) approval. This exclusivity includes marketing authorization holder status and data exclusivity, offering comprehensive protection in the market.