An application for marketing authorization of a new drug developed by Jiangsu Hengrui Pharmaceuticals Co.,Ltd. (ASX: 600276) has been formally accepted for review by the European Medicines Agency (EMA).
This marks the first time the company's own independently researched and developed innovative drug has been submitted for approval within the European Union.
The drug in question, Rezvilutamide tablets, is intended for use in combination with androgen deprivation therapy (ADT) to treat adult male patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC).