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Innovent and Lilly Jointly Announce the NMPA Granted Marketing Approval for HALPRYZA in China

SAN FRANCISCO and SUZHOU, China, Oct. 9, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality

· 10/09/2020 07:12

SAN FRANCISCO and SUZHOU, China, Oct. 9, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ((", Lilly", , NYSE:LLY), today jointly announce that HALPRYZA® (rituximab injection), a recombinant human/murine chimeric monoclonal antibody drug co-developed by Innovent and Lilly, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL) in China. HALPRYZA® (rituximab injection) is Innovent's fourth monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection) and SULINNO® (adalimumab injection). It is also the second monoclonal antibody approved by NMPA that was co-developed by Innovent and Lilly after the approval of TYVYT®.

The clinical efficacy and safety of rituximab in CD20-positive non-Hodgkin's lymphoma have been confirmed in several large-scale clinical trials. Rituximab injection, approved by FDA in 1997, is approved for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA),granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and moderate to severe pemphigus vulgaris (PV).  The efficacy and safety of rituximab have been well recognized worldwide. HALPRYZA® (rituximab injection) is a recombinant human/murine chimeric monoclonal antibody drug co-developed by Innovent and Eli Lilly. The launch of HALPRYZA® (rituximab injection) will provide Chinese patients with high-quality and relatively more affordable rituximab injection.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "HALPRYZA® (rituximab injection) is another example of our success with the National Major New Drug Innovation and Development Projects and the fourth monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection),BYVASDA® (bevacizumab injection), and SULINNO® (adalimumab injection). We hope to bring this high-quality drugs to more patients in need in China as soon as possible."

Dr. Li WANG, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: "We're excited that Lilly and Innovent strategic collaboration has reached another success. Lymphoma is one of the malignant tumors with rapid growing incidence. However, the survival rate is also relatively higher than other tumor types when having appropriate treatment. The approval of HALPRYZA® (rituximab injection) will bring a new option to Chinese Lymphoma patients, help them to improve quality of life & prolong their survivals."