Approval document of US clinical trial of anti OX40 monoclonal antibody ibi101 obtained by Cinda Bio

December 5, 2018 / Meitong news agency / -- Xinda biopharmaceutical (Hong Kong stock exchange code: 01801), is a biopharmaceutical company dedicated to the research and development, production and sales of new antibody drugs for the treatment of major diseases such as tumors and autoimmune diseases Today, the company announced that its developed recombinant all human anti-tumor necrosis factor receptor superfamily member 4 (OX40) monoclonal antibody (R & D Code: ibi101) has obtained the drug clinical trial approval issued by the U.S Food and Drug Administration (FDA), and intends to carry out clinical research in patients with advanced solid tumors Ibi101 is the third clinical research product of Cinda biology after ibi308 (anti-CD47 monoclonal antibody, anti-PD-1 monoclonal antibody) and ibi188 (anti-CD47 monoclonal antibody), and it is also the first domestic anti OX40 monoclonal antibody drug to obtain clinical trial approval in the United States "Xinda biology has been exploring the most cutting-edge research direction and benchmarking international R & D and production standards," said Dr Yu Dechao, founder, chairman and President of Xinda biology This time, the anti OX40 monoclonal antibody was successfully approved by FDA clinical research, which once again proved the efforts of Cinda biology in innovation and research We hope to work with you to make more breakthroughs in the field of innovative biopharmaceutics and benefit patients around the world as soon as possible " About the recombinant all human anti-tumor necrosis factor receptor superfamily member 4 (OX40) monoclonal antibody (R & D Code: ibi101) for injection of ibi101, which is an OX40 agonist with independent intellectual property rights developed by Cinda biopharmaceutical, and is intended to be used in the treatment of a variety of solid tumor diseases According to preclinical data, ibi101 has a clear mechanism of action, which can significantly enhance the activation of effector T cells and mediate the clearance of regulatory T cells, thus inhibiting the growth of tumor cells Compared with the published target antibodies, ibi101 has stronger ability of activating T cells and antitumor effect OX40 agonist is expected to be combined with the company's anti-PD-1 monoclonal antibody sindili MAb (R & D Code: ibi308) and other drugs in the R & D pipeline after being put on the market to expand to more unsatisfied tumor treatment fields At present, there is no single monoclonal antibody for the same target in the world About ibi188 ibi188 is an anti-cd47igg4 monoclonal antibody developed by Cinda biopharmaceutical, which has independent intellectual property rights It is intended to be used to treat a variety of blood tumors and solid tumors, including non Hodgkin's lymphoma and ovarian cancer In vitro and in vivo experiments show that ibi188 can combine with the CD47 antigen on the surface of tumor cells, block the cd47-sirp α signal pathway, inhibit the "don't eat me" signal transmitted by CD47, and promote macrophages to recognize the "eat me" signal transmitted by tumor cells, thus phagocytizing tumor cells and exerting the anti-tumor effect of the body According to the preclinical data, ibi188 has stronger antitumor activity compared with the similar drugs Sintilimab is a kind of all human programmed cell death 1 (PD-1) monoclonal antibody It can bind to PD-1 receptor on the surface of T cell, block its binding with PD-L1, make T cell and self immune play a normal role, and then kill tumor cells Sindilimab is a PD-1 monoclonal antibody jointly developed by Cinda biology and Lilly Pharmaceutical Group in China On April 16, 2018, SDA formally received the listing application of cindilimab submitted by Cinda bio, and listed it in the priority review variety on April 23 The first indication of the drug application is relapsed / refractory classic Hodgkin's lymphoma 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, Cinda biology is committed to the development, production and sale of new monoclonal antibody drugs for the treatment of major diseases such as cancer 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 17 new monoclonal antibody varieties, covering four disease areas, including tumor, fundus oculi disease, autoimmune disease, metabolic disease, and four varieties enter clinical phase III In the study, two products (cindilimab injection and adalimumab injection biological similar drugs) were accepted by the State Food and drug administration, and cindilimab injection entered the priority review 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 Lilly Pharmaceutical Group, adimab and other international pharmaceutical companies 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.