3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for an additional indication. The PD-L1 monoclonal antibody (mAb) is now indicated for the treatment of unresectable or metastatic solid tumors with high tumor mutational burden (TMB-H) that have failed previous standard treatments and have no satisfactory alternative treatments.
Tumor mutational burden (TMB) is recognized as a potential predictor of immunotherapy efficacy. Studies have indicated that patients with TMB-H tumors may respond better to immune checkpoint inhibitors, and TMB-H has been adopted as a biomarker for pan-cancer treatment in the United States. Envafolimab, the world’s first PD-L1 single-domain antibody and human IgG1 Fc fusion protein capable of subcutaneous injection, originated with Alphamab Oncology (HKG: 9966), with 3D Medicines as a co-development partner under a deal signed in January 2019. In March 2020, Simcere Pharmaceutical Group (HKG: 2096) joined the alliance, taking on exclusive responsibility for the drug’s commercial promotion in mainland China. The molecule received approval in China in November 2021 to treat adult patients with microsatellite instability-high (MSI-H) or dMMR-positive advanced solid tumors.- Flcube.com
