The two clinical studies of rituximab biological analogue ibi301 reached the preset primary end point

May 8, 2019 / Meitong news agency / -- Xinda biopharmaceutical Co., Ltd and Lilly Pharmaceutical Co., Ltd announced that two clinical studies of recombinant human mouse chimeric anti-CD20 monoclonal antibody injection (R & D Code: ibi301) jointly developed by the two parties in accordance with the original drug rituximab (trade name: Rituximab / rituxan) - phase III clinical study on primary treatment of diffuse large B-cell lymphoma (cibi301a301) and C The study of pharmacokinetics (PK) in D20 positive B-cell lymphoma subjects (cibi301a201) reached the pre-determined primary end point The detailed research results will be announced at the recent academic conference Cibi301a201 is a randomized, double-blind, parallel, controlled pharmacokinetic study comparing the PK, safety, tolerability and immunogenicity of ibi301 and rituximab in CD20 positive B-cell lymphoma subjects in China, involving 181 subjects The main purpose of this study is to compare the PK data of the two Cibi301a301 is a multicenter, randomized, double-blind, parallel, positive control phase III clinical study conducted in China to evaluate the efficacy and safety of ibi301 and rituximab in the first-line treatment of patients with diffuse large B-cell lymphoma The aim of this study was to evaluate the efficacy and safety of ibi301 combined with chop compared with rituximab combined with chop in the initial treatment of diffuse large B-cell lymphoma The primary endpoint was objective response rate (ORR) Professor Qiu lugui, hematology hospital, Chinese Academy of Medical Sciences, said: "diffuse large B-cell lymphoma is the most common type of lymphoma in China Rituximab is the standard treatment for diffuse large B-cell lymphoma The availability of high-quality rituximab biosimilars will be improved and more patients will benefit " Professor Zhu Jun, Cancer Hospital of Peking University, said: "with the joint efforts of all researchers, the two key studies have reached the main research end point, and we are very happy, which has laid a solid foundation for the next step of the application and listing of the drug Patients with diffuse large b-lymphoblastoma in China need such high-quality biological drugs." Dr Yu Dechao, founder and chairman of the XinDa biopharmaceutical, said: "malignant lymphoma is one of the ten most malignant tumors with high morbidity and mortality in China The incidence rate incidence rate is increasing in recent years, which brings heavy financial burden to the majority of patients Anti-CD20 monoclonal antibody is an effective treatment for lymphoma, and there is only one biological analogue of rituximab approved for marketing in China As a potential biological analogue of rituximab, the research results of ibi301 are encouraging, and it is hoped that it can be put on the market as soon as possible, benefiting more lymphoma patients and families " Dr Wang Li, senior vice president of Lilly China and head of the center for drug development and medical affairs, said: "the results of this study have significant clinical significance, and are also an outstanding embodiment of the outstanding R & D ability of Cinda biopharmaceuticals It is expected that in the future, ibi301 will be approved for market as soon as possible, bringing more accessible treatment options for lymphoma patients in China " About ibi301, ibi301 is a candidate biological analogue of rituximab injection, which was jointly developed by Cinda biopharmaceutical and Lilly, also known as recombinant human mouse chimeric anti-CD20 monoclonal antibody injection Rituximab is a monoclonal antibody with CD20 antigen as the target, which combines with CD20 antigen on the surface of B-lymphocyte, and mediates the dissolution of normal and malignant B cells in vivo through complement dependent cytotoxic effect (CDC) and antibody dependent cytotoxic effect (ADCC), so as to achieve the therapeutic effect of anti-tumor With regard to Xinda biology, it is the ideal and goal of Xinda biology to develop high-quality biological medicine that people can afford Founded in 2011, Xinda biology is committed to the development, production and sale of innovative drugs for the treatment of major diseases such as cancer On October 31, 2018, Cinda biopharmaceutical was listed on the main board of the stock exchange of Hong Kong Limited, stock code: 01801 At present, the company has established a high-quality technology platform throughout the development cycle of biological innovative drugs, including R & D, pharmaceutical development and industrialization, clinical research and marketing platforms, and has established a product chain including 20 new drug varieties under research, covering four disease areas, including tumor, fundus disease, autoimmune disease, metabolic disease, and 14 varieties have entered clinical trials, including Four varieties were studied in clinical phase III, two McAb products were accepted by the State Food and Drug Administration and included in the priority review, one product (cindilimab injection, trade name: dabushu ®) was approved by the State Food and Drug Administration for listing, and the first approved indication was relapsed / refractory classic Hodgkin's lymphoma Xinda biology has set up a team of high-end biomedical development and industrialization talents with international advanced level, including many returned experts, and has reached strategic cooperation with international pharmaceutical companies such as Eli Lilly pharmaceutical, adimab, Incyte and Hanmi of South Korea Xinda bio hopes to work with you to improve the development level of China's biopharmaceutical industry, so as to meet the people's drug access and the people's pursuit of life and health About Lilly pharmaceutical Lilly pharmaceutical was founded in May 1876 Its headquarter is located in Indianapolis, Indiana, USA As a global leader in the medical and health industry, Lilly is committed to returning patients with innovation and caring for life Over the past hundred years since its establishment, we have always adhered to the concept of providing patients with the best quality drugs with the latest technology Lilly's product line covers cardiovascular, diabetes, tumor, immunity, central nervous system, pain and other fields Its products are sold in 120 countries around the world, clinical trials and research are conducted in 55 countries around the world, and drug production bases are established in 13 countries around the world Around 38000 employees are employed in the world, and nearly 8000 people are engaged in R & D work 24% of the annual sales are invested in R & D in the past five years, the total R & D investment has reached US $25.5 billion For more information, please visit www.lily.com In March 2015, Cinda bio Pharmaceutical (Cinda bio) and Lilly pharmaceutical reached a biotechnology drug development cooperation on the strategic cooperation between Cinda bio and Lilly pharmaceutical, which is also one of the largest cooperation between China's Biopharmaceutical Enterprises and multinational pharmaceutical enterprises so far According to the terms of cooperation, in the next decade, Cinda biology and Lilly pharmaceutical will jointly develop and commercialize at least three tumor treatment antibodies In October 2015, the two sides announced to expand the established drug development cooperation again and add three new tumor treatment antibodies The two cooperation with Lilly pharmaceutical marks the establishment of a comprehensive strategic cooperation between China's innovative pharmaceutical enterprises and global pharmaceutical giants, covering new drug research and development, production quality and marketing Source: Xinda biopharmaceutical