Clinical approval of recombinant human anti TNF α monoclonal antibody for injection

Jiankangyuan and Lizhu group's joint-venture subsidiary announced today (March 7) that Zhuhai Lizhu monoclonal antibody Biotechnology Co., Ltd (hereinafter referred to as monoclonal antibody company) applied for clinical research of recombinant human anti-tumor necrosis factor alpha monoclonal antibody for injection (hereinafter referred to as TNF - α) approved by the State Food and Drug Administration (SFDA) On March 4, 2014, McAb company received the approval document for clinical trials of drugs issued by SFDA, with the approval number of 2014l00371, and approved the McAb company to declare the anti-tumor necrosis factor monoclonal antibody for phase I clinical trials Zhuhai Lizhu McAb Biotechnology Co., Ltd is jointly invested and established by jiankangyuan and Lizhu group, with a registered capital of 300 million yuan Lizhu group holds 51% of its equity and jiankangyuan, the controlling shareholder of Lizhu, holds 49% of its equity Lizhu McAb was founded in 2010, introducing a professional team to carry out strategic development of McAb products, At present, jiankangyuan, as the controlling shareholder of Lizhu group, directly and indirectly holds 73.16% equity of McAb company According to reports, TNF - α is a class 1 biological product independently developed by the company to achieve strategic transformation, which is mainly used in rheumatoid arthritis, psoriasis, ankylosing spondylitis and other autoimmune diseases In 2013, the sales amount of similar foreign products was close to 30 billion US dollars: TNF - α similar products include anacept of Amgen, adamumumab of Abbott, infliximab of Johnson & Johnson and gelimumumab According to incomplete statistics, the sales amount in 2013 reached 8.3 billion US dollars, 10.7 billion US dollars, 8.9 billion US dollars and 930 million US dollars respectively; follow-up arrangement: after obtaining the clinical approval, the company will quickly organize phase I clinical trials, Increase the control of the original research drug, and explore the key indicators of product safety, efficacy and initial dose   After obtaining the above approval documents, McAb company will organize and implement the clinical trial as soon as possible in accordance with the requirements of SFDA clinical trial, including adding the original research drug as the control drug in the PD study, initially exploring the efficacy of the product, further refining and improving the program with the clinical research responsible unit before the implementation of the clinical trial, and paying close attention to the same products and animal tests during the clinical trial The potential safety risk of exposure, combined with the non clinical and clinical of similar products, and the non clinical research of this product, is designed as the initial measurement of safety After the clinical approval of TNF - α monoclonal antibody is obtained, it is expected that there will be clinical approval for tumor products in the future.