CFDA accepts clinical application for biocompatibility

Source: Sina pharmaceutical 2017-04-06 On April 5, 2017, Xikang biomedical Co., Ltd announced that its first clinical trial application (CTA) - jhl1101 (recombinant human mouse chimeric anti-CD20 monoclonal antibody injection) was accepted by China food and Drug Administration (CFDA) on April 1 (acceptance No.: cxsl1700027 E) and entered the examination Program Xikang's application is based on the guidelines for the newly released bioequivalent drugs in 2015 Jhl1101 is an ongoing rituximab biological similar drug It is the first product developed by Xikang itself and the first product in the strategic alliance of biological drugs established by Xikang and Sanofi It has obtained the approval of clinical trial application for new drugs in Europe (UK) in February 2016 and submitted the clinical trial application to CFDA in early February 2017 Rituximab can be used to treat rheumatoid arthritis (RA) and non Hodgkin's lymphoma (NHL) In mainland China, rituximab is used to treat non Hodgkin's lymphoma (NHL) Every year, about 4.3 million Chinese are diagnosed with cancer, of which about 80000 are diagnosed with non Hodgkin's lymphoma (NHL) Once jhl1101 goes on the market in the future, it will be committed to bringing high-quality and affordable innovative biotherapy to Chinese patients, so as to improve the disease treatment and management of non Hodgkin's lymphoma in China The original research drug used in the clinical trial was produced by Xikang's facility in Wuhan, China Wuhan also has the world's largest biopharmaceutical production plant based on single use technology Xikang is developing bio similar drugs for Chinese and global markets In addition to conducting clinical trials in mainland China, Xikang is currently the only developer of biosimilars in Greater China, and has obtained the approval of EU and Taiwan authorities to conduct clinical trials of rituximab biosimilars A randomized, double-blind, parallel group, multicenter study was conducted to compare the effects of jhl1101 and mabthera in the treatment of moderate to severe rheumatoid arthritis (RA) "This application is accepted on behalf of our efforts over the years," said Mr Qiao Shirui, co-founder and CEO of Xikang This is an important milestone for Xikang and the first one of our clinical trial application plans This is the first step for Xikang to make cancer therapy more popular and affordable in China I am very proud that our team can realize the development plan of jhl1101 At present, Xikang has 5 biological similar drugs under development, the fastest-growing product is jhl1101, followed by jhl1149, which is used to treat colorectal cancer It is expected to send an application for ind to Europe in the third quarter of next year Three other biological analogues were developed, including jhl1922 with cystic fibrosis, jhl1188 with breast cancer and jhl1228 with autoimmune disease In December 2016, Sanofi and Xikang biology announced a strategic alliance partnership, and Sanofi gave priority to the Chinese market rights of four biological analogues jhl1101, jhl1149, jhl1188 and jhl1228 in Xikang's R & D In addition, the scope of cooperation between Xikang biology and Sanofi will not be limited to China's bio similar drug market, but also covers other biological preparations and markets outside China.