About Envafolimab (KN035)

Envafolimab (KN035) is a PD-L1 single-domain antibody Fc fusion protein independently developed by Alphamab. Based on the unique design, KN035 has advantages in safety, convenience and compliance, and can be used for patients who are not suitable for intravenous infusion with a lower medical cost. On March 30, 2020, Alphamab, 3D Medicines and Simcere reached a three-way strategic collaboration. Alphamab, as the original research party, is responsible for production and quality, 3D Medicines is responsible for global clinical development in the field of oncology, registration and commercialization abroad, and Simcere is responsible for the exclusive commercial promotion of the product in mainland China. At present, KN035 is being evaluated in clinical trials for multiple cancer indications in China, the United States and Japan, and the research for multiple indications have entered the registration/clinical Phase III. KN035 has been awarded orphan drug designation (ODD) by FDA in the United States for the treatment of advanced biliary tract cancer. On December 17, 2020, the NMPA officially accepted the NDA of Envafolimab (KN035).