Two monoclonal antibodies of Cinda biological entered phase III clinical trial (vs rituximab and sumac)

Source: BioBAY & Xinda biology was founded on September 14, 2016 in 2011 Xinda biology, which is dedicated to the development and production of new antibody drugs for the treatment of various difficult diseases endangering human health and life, has recently sent two news for the benefit of patients The phase III clinical trial of ibi303 was carried out in Chinese patients with ankylosing spondylitis The head-to-head comparison of the PK / be of ibi303 and sumerial showed safety and effectiveness The parallel control clinical trial of ibi301 and the original drug rituximab was carried out in patients with primary diffuse large B-cell lymphoma to verify the similarity in effectiveness and safety Ibi301vs rituximab ibi301 is a biological similar drug developed jointly by Cinda biopharmaceutical (Suzhou) Co., Ltd and Lilly pharmaceutical group of the United States It has been approved by the State Food and Drug Administration and completed phase I safety research The results of the completed clinical trials show that the safety of ibi301 is good On September 13, 2016, Xinda biological system announced that it is now officially entering phase III clinical study: a parallel controlled clinical trial of ibi301 and the original drug rituximab was carried out in patients with initially treated diffuse large B-cell lymphoma (DLBCL), so as to verify the similarity between ibi301 and the original drug rituximab in terms of effectiveness and safety It is reported that the clinical trial cost over 100 million yuan, and selected the top blood disease treatment hospitals in China to carry out research The company hopes that the majority of patients will have the opportunity to participate in the clinical study compared with the original research drug Ibi303vs xiumeile ibi303 is an all human IgG1 monoclonal antibody drug in the research and development stage, which can bind and neutralize the inflammatory cytokine TNF - α The amino acid sequence of ibi303 is the same as that of adalimumab The high similarity between ibi303 and adalimumab has been proved by a set of leading physical and chemical analysis methods In the head-to-head experiments in primates, ibi303 was highly similar to adalimumab in PK / PD, toxicology and pharmacological tests In a small sample of clinical trials, ibi303 showed good safety in healthy subjects At present, the head-to-head comparison between PK / be and adalimumab is carried out in healthy subjects, and the head-to-head comparison with adalimumab is carried out in patients with ankylosing spondylitis On September 13, 2016, Xinda biopharmaceutical (Suzhou) Co., Ltd announced to carry out phase III clinical trials of ibi303 in China In this study, the head-to-head ratio of ibi303 and sumerial in patients with ankylosing spondylitis was used for PK / be, safety and effectiveness In January 2016, ibi303 was approved by China food and Drug Administration (CFDA) to carry out clinical trials in accordance with the guiding principles of bioequivalent drugs, and has successfully completed the safety clinical trials "All the physical and chemical analysis and pre clinical similarity studies show that ibi303 is highly similar to Sumeria, which is enough to support the PK / be, clinical safety and effectiveness comparative study of ibi303 and Sumeria," said Dr Yu Dechao, CEO of Xinda biology The trial marks the transformation of Cinda biology from an early clinical company to a biopharmaceutical company with multiple varieties in the late clinical development stage "