Zhaoke Ophthalmology’s Melphalan Receives FDA Orphan Drug Designation
July 31, 2025
Source: drugdu
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On July 30, Zhaoke Ophthalmology (06622) issued an announcement, announcing that its melphalan drug has been granted orphan drug certification by the U.S. Food and Drug Administration (FDA) for the treatment of retinoblastoma in children.
This certification lays the regulatory foundation for the company to submit an IND application in the U.S. If melphalan is successfully developed and approved, the company will enjoy seven years of exclusive U.S. market rights after the IND application, protecting both marketing authorization holder status and data exclusivity.
Retinoblastoma is a rare eye cancer that primarily affects children under five years old. It affects approximately 200 to 300 cases annually in the United States and approximately 1 in every 15,000 to 18,000 live births worldwide. While the company cannot guarantee the success of the development or commercialization of melphalan, the announcement advises shareholders and potential investors to exercise caution when trading the company's shares.
Source：https://finance.eastmoney.com/a/202507303471632174.html
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