TCON - Tracon Pharma stock jumps 13% on regulatory approval of envafolimab in China

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

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Tracon Pharma stock jumps 13% on regulatory approval of envafolimab in China