Envafolimab is a fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc independently invented by Alphamab Oncology. Envafolimab was in pre-clinical stage when the Co-Development Agreements were first entered into between the Company and Alphamab in February 2016. Since then, we took full responsibility for global clinical development of envafolimab, which has undergone clinical trials across for multiple tumor types in the U.S., China and Japan. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.
At present, Envafolimab (KN035) is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab (KN035) obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of previously treated MSI-H/dMMR advanced solid tumors.