Innovent Announces the NMPA Granted Marketing Approval for BYVASDA® (Bevacizumab Biosimilar) in China

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that BYVASDA® (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China. BYVASDA® is Innovent's second monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection, officially approved for treatment of patients with Hodgkin's lymphoma in December 2018).

In recent years, the cancer burden in China has been continuously increasing. According to the report of Cancer Today from the WHO's International Agency for Cancer Research, there were 4.285 million newly diagnosed cancer patients and 2.865 million deaths from cancer in China in 2018. Among the malignant tumors in China, lung cancer ranks first both in incidence rate (0.774 million newly diagnosed patients) and mortality rate (0.691 million deaths). Colorectal cancer ranks second in incidence rate (0.517 million newly diagnosed patients) and fifth in mortality rate (0.245 million deaths). Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer, and in China it was approved for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide. Currently there still remains huge unmet clinical demand for bevacizumab treatment in China, as many ordinary Chinese patients cannot afford for it. BYVASDA® is an anti-VEGF humanized monoclonal antibody and a bevacizumab biosimilar independently developed by Innovent. The launch of BYVASDA® will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar injection.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "BYVASDA® is another example of our success with the National Major New Drug Innovation and Development Projects and the second monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection). We hope to bring this high-quality and cost-saving drugs to more patients in need in China as soon as possible. In January 2020, Innovent out-licensed the commercial rights of BYVASDA® in the United States and Canada to Coherus BioSciences, a leading biosimilar company, demonstrated an international recognition of the quality of BYVASDA®. We are looking forward to working together to make BYVASDA® benefit more patients globally."