Mabwell (688062.SH), a biopharmaceutical company, announced on Friday that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its self-developed novel Nectin-4-targeting ADC (R&D Code: 9MW2821) intended to treat locally advanced or metastatic Nectin-4 positive triple negative breast cancer (TNBC).

This move is aimed at accelerating the development and review of pharmaceuticals used to treat critical conditions, therefore lowering the time required to bring these drugs to market.

The product has received multiple regulatory designations from the FDA within the last six months. Previously, the product received FTD for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) and recurrent or metastatic cervical cancer (CC) progressed on or subsequent to prior treatment with a platinum-based chemotherapy regimen, and also received Orphan Drug Designation (ODD) for the treatment of esophageal cancer (EC).