Lepu Bio-B (02157) announced that the company's drug candidate MRG004A (a novel targeted tissue factor...
Zhitong Finance App News, Lepu Bio-B (02157) announced that the company's drug candidate MRG004A (a novel specific antibody drug conjugate targeting tissue factors) has been granted Fast Track Qualification (FTD) by the US Food and Drug Administration (FDA) to treat pancreatic cancer.
Previously, in January and February 2023, the company obtained FDA's Orphan Drug Qualification (ODD) certification for MRG004A.
According to reports, FTD was established to promote and speed up the clinical development and evaluation process of drugs to meet the unmet medical needs of serious or life-threatening diseases. According to relevant regulations, an FTD-qualified drug candidate means that it has the opportunity to expedite the review process through various forms.
MRG004A is a novel specific antibody drug conjugate targeting tissue factors. The company is currently conducting phase I/II clinical studies in the US and China. The group has observed anti-tumor activity signals for pancreatic cancer, triple-negative breast cancer, and cervical cancer.
The acquisition of FTD for the MRG004A is another milestone for the company shortly after receiving ODD from the FDA.