Gelonghui, December 29 | Lepu Bio-B (02157.HK) announced that the company's drug candidate MRG003 (an epidermal growth factor receptor (“EGFR”) antibody drug conjugate (“ADC”) drug candidate and the company's core product) has recently successfully completed the enrollment of all subjects in key registered phase IIb clinical trials to treat recurrent or metastatic nasopharyngeal cancer (“R/M NPC”).
The trial is a randomized, open, multi-center key registration phase IIb clinical study. Enrollment of subjects began in April 2023. As of the date of this announcement, 173 participants have successfully completed enrollment. Previously, MRG003 was certified as a breakthrough therapeutic drug by the Drug Evaluation Center of the China National Drug Administration, obtained the US Food and Drug Administration (“FDA”) orphan drug qualification certification (for the treatment of R/M NPC), and was granted fast track status by the FDA.