NMPA Accepts New Drug Application for IBI301, a Rituximab Biosimilar Developed by Innovent Biologics and Lilly

Suzhou, June 27, 2019 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801) and Eli Lilly and Company jointly announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for IBI301, a biosimilar of rituximab (brand name: MabThera/Rituxan) injection, co-developed by the two companies. This follows Tyvyt^®(Sintilimab Injection), the adalimumab injection biosimilar (IBI303), and the bevacizumab injection biosimilar (IBI305) have submitted marketing applications and been included in the priority review, marking the fourth new drug marketing application accepted by the NMPA for Innovent Bio.

IBI301 is a recombinant chimeric human-mouse monoclonal antibody injection targeting the cell surface protein CD20, jointly developed by Innovent Biologics and Eli Lilly and Company, based on the originator drug rituximab (brand names: MabThera/Rituxan). It is indicated for the treatment of diseases such as non-Hodgkin’s lymphoma (NHL). Since its market launch in 1997, rituximab has been approved in Europe and the United States for indications including non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA). Its significant efficacy and favorable safety profile have been widely recognized. However, the high price of rituximab injection in China has resulted in a substantial unmet clinical need.IBI301 willProviding more Chinese patients with affordable, high-quality alternative injectable rituximab.

Innovent Biologics and Eli Lilly jointly conducted clinical studies using the originator rituximab injection as a comparator, including a tolerance study and a pharmacokinetic (PK) comparative study of IBI301 in patients with CD20-positive B-cell lymphoma who had achieved complete response after prior treatment, as well as a clinical efficacy comparative study of IBI301 in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL), to evaluate the clinical similarity between IBI301 and the originator rituximab injection. The clinical trial results demonstrated that both primary comparative studies met their primary endpoints.

Professor Qiu Lugui from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, stated: “We conducted two clinical studies using the originator drug rituximab injection as a control. Based on the favorable data from these clinical studies, the National Medical Products Administration (NMPA) has accepted the marketing application for IBI301. We believe that the launch of high-quality rituximab biosimilars is expected to further reduce the burden on patients, benefiting a broad population of patients and their families.”

Professor Zhu Jun from Peking University Cancer Hospital stated: "IBI301 in combination with the CHOP regimen and the original drug in combination with the CHOP regimen in initial"Treatment of DLBCLThe results of the Phase III efficacy comparison study showed that the primary endpoint indicators for both groupsObjectiveNo differences were observed in the objective response rate (ORR) or safety profile, confirming the clinical equivalence of IBI301 to the originator drug. We hope this medication will be approved for market access soon, thereby benefiting more patients with lymphoma and their families.”

Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center, stated, “IBI301 is another fruitful outcome of the strategic collaboration between Eli Lilly and Innovent Bio. We look forward to its imminent approval and market launch, thereby providing Chinese lymphoma patients with more accessible treatment options.”

Innovent BiologicsDr. Hui Zhou, Vice President of Medical Science and Strategic Oncologystated: “Currently, we have a total of 14 products in clinical development, four of which have entered Phase III clinical trials. The first product submitted by the company is Tyvyt.”^®(Sintilimab Injection) has been successfully approved for market launch. IBI301 is the fourth product submitted by Innovent Bio for marketing approval. We are delighted to achieve this significant milestone and hope to bring more high-quality medicines to patients. We will continue to enrich our product pipeline and develop high-quality drugs to benefit a broader population.”