Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announces that its self-developed novel Nectin-4-targeting ADC (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic Nectin-4 positive triple negative breast cancer (TNBC).

The FDA's FTD is intended to expedite the development and review of pharmaceuticals used to treat critical conditions, therefore speeding up the process of bringing these drugs to market. Therapeutics with Fast Track Designation are likely to obtain priority evaluation and speedy approval if they meet the appropriate criteria.

9MW2821 has received multiple regulatory designations from the FDA within just 6 months. Prior to this, 9MW2821 has been granted FTD for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) and recurrent or metastatic cervical cancer (CC) progressed on or following prior treatment with a platinum-based chemotherapy regimen, and also granted Orphan Drug Designation (ODD) for the treatment of esophageal cancer (EC), highlighting its potential and innovation in treating multiple tumors. These designations not only accelerate the development process of 9MW2821 but also lay the groundwork for its potential future priority review.

About 9MW2821

9MW2821 is the first site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of CC, EC and breast cancer. 9MW2821 has been granted FTD by FDA for the treatment of advanced, recurrent, or metastatic ESCC in Feb. 2024, and also respectively granted ODD and FTD for the treatment of esophageal cancer and recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen in May 2024. Then, it has been granted FTD for the treatment of locally advanced or metastatic Nectin-4 positive TNBC in July, 2024.

9MW2821 achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.