- TRACON Pharmaceuticals (NASDAQ:TCON) reports that its partners Alphamab Oncology and 3D Medicines (Beijing) Co., Ltd. have announced that envafolimab (KN035), the world's first single-domain PD-L1 antibody formulated for subcutaneous injection received marketing authorization from the Chinese National Medical Products Administration.
- Shares up 13% premarket at $3.05.
- Envafolimab was approved for adult patients with microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) advanced solid tumors, including those patients with advanced colorectal cancer and other advanced solid tumors.
- Prior to this approval, all marketed PD-1 and PD-L1 antibody drugs required intravenous infusions. As a subcutaneously administered PD-L1 antibody, envafolimab can be administered within 30 seconds in the physician’s office—thereby increasing convenience, shortening treatment time and sparing patients from the risk of infusion reactions.
- In a Phase 2 clinical study in patients with advanced dMMR/MSI-H tumors who received one or more lines of treatment, envafolimab demonstrated an objective response rate of 44.7%. Median progression-free survival was 11.1 months and the 12-month overall survival rate was 73.6%.