Innovent Biologics, Inc. announced that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for a biosimilar product candidate of bevacizumab (Avastin®). This NDA by Innovent is the third that has been accepted by the NMPA following Tyvyt® (sintilimab injection, marketing approval granted on December 24, 2018) and IBI-303 (a biosimilar product candidate of adalimumab). IBI-305 is a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody independently developed by Innovent for the treatment of non-small cell lung cancer (NSCLC), colorectal cancer and other malignant tumors. Bevacizumab (marketed under the trade name Avastin® in China) has been approved globally for the treatment of multiple types of malignant tumors including NSCLC and has a favorable safety and efficacy profile. Despite the huge demand for effective cancer therapies in China, the adoption rate of bevacizumab (Avastin®) is relatively low due to its rather low affordability. Innovent's biosimilar product candidate of bevacizumab, IBI-305, is expected to offer a high-quality and affordable alternative to patients in China. The NDA is based on clinical data generated from two clinical studies, namely a Phase 3 comparative study of efficacy and safety in advanced non-squamous NSCLC patients and a pharmacokinetics (PK) study in healthy subjects. Both studies directly compare IBI-305 to bevacizumab and have met their pre-defined primary endpoints.