The application of anti IL6 monoclonal antibody of yaominglikang in the treatment of rheumatoid arthritis was accepted by CFDA

Wuxi yaominglikang biotech Co., Ltd., a joint venture of Wuxi yaominglikang biotech Co., Ltd., has successfully applied to China food and Drug Administration (CFDA) for the clinical trial of new drugs (ind) Wuxi yaominglikang Biotechnology Co., Ltd., a joint venture of Wuxi yaominglikang Biotechnology Co., Ltd., was established in September 2012 by Wuxi yaomingkant and MedImmune, a global biopharmaceutical branch of AstraZeneca, aiming to jointly promote the R & D and commercial promotion of new biopharmaceutical medi-5117 Medi-5117 is an innovative long-acting monoclonal antibody with the world's leading level, which is mainly used to treat autoimmune and inflammatory diseases It is also the first domestic enterprise to carry out such cooperation with international pharmaceutical companies in China In December 2014, yaomingkant completed the pharmaceutical research, non clinical research and preparation of clinical application materials entrusted by yaominglikang Yaominglikang immediately submitted the clinical trial application of class 1 biological new drug to Jiangsu food and drug administration In January 2015, biopharmaceutical and preclinical facilities in Wuxi, Suzhou and Shanghai passed the on-site inspection of Jiangsu food and drug administration At present, the clinical trial application of medi-5117 has successfully entered the technical review system of the State Food and drug administration Wuxi apptec will continue to carry out drug registration, preclinical and clinical trials in China under the entrustment of Wuxi apptec, and continue to provide clinical samples for medi-5117 project through its first domestic R & D and production base of cGMP biopharmaceutical original solution and sterile preparation established in accordance with American, European and Chinese standards The base's biopharmaceutical stock solution and sterile preparation have been used in clinical research in the United States and Australia, and will be used in clinical trials in the European Union and Singapore "I am very pleased to make the expected progress in the cooperation project with MedImmune, an important class 1 innovative biological medicine," said Dr Li Ge, chairman and chief executive officer of Wuxi apptec "The international leading and unique integrated technology platform for discovery, development and production of biological medicine of Wuxi apptec is committed to providing the highest quality services to global customers As a leading R & D platform company in the industry, Wuxi apptec hopes to cooperate with global customers to develop innovative biopharmaceuticals in China, so as to benefit the vast number of patients in China and around the world as soon as possible "