Jiahe biopharmaceutical Co., Ltd., a subsidiary of Watson biology, has obtained the clinical trial approval document issued by the Ministry of food and drug safety of South Korea for its independently developed product "recombinant anti-tumor necrosis factor - α all human monoclonal antibody injection"
According to reports, the approved drug is a monoclonal antibody biological similar drug independently developed by Jiahe biology
Its original research drug, Humira ® (Chinese trade name xiumeile, Chinese and English common names are adalimumab and adalimumab respectively), was first developed and listed by Abbott in 2003, and its global sales reached 106 in 2013 Billion US dollars, is the world's largest single product sales of drugs
"Recombinant anti TNF - α all human monoclonal antibody injection" is a kind of all human monoclonal antibody drug, which can inhibit the activation of TNF - α by binding with TNF - α Receptor, so as to inhibit the inflammatory response related to autoimmune diseases
The approved clinical indications mainly include moderate and severe active rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis arthritis, mandatory spondylitis, Crohn's disease, plaque psoriasis and ulcerative colitis and other autoimmune diseases
In May 2013, Jiahe biology signed a cooperation agreement on overseas development and promotion of the product with Korea biocnd company, and at the end of 2013, biocnd company submitted the application for clinical trial of the product in Korea to the Ministry of food and drug safety (MFDs) of Korea
Industry insiders said that in recent years, South Korea has taken biomedical as a new engine of domestic economic development, which has led to South Korea quickly becoming one of the hot spots of global drug clinical trials
From 2004 to 2009, the number of drug clinical trials implemented in South Korea has doubled
According to the statistics of clinical trials.gov, according to the number of drug trials in countries around the world, South Korea has been ranked from 34th to 12th
However, Korea implements a very strict clinical trial evaluation method, which requires that all new chemical entities and biological products exported to Korea must provide clinical trial data in Korea without considering clinical trial data in other Asian countries, which greatly increases the cost of imported drugs
And after the clinical trial is completed, enterprises are required to submit complete production data in the process of drug approval
Therefore, Watson bio's product has a long way to go before it is officially launched in South Korea
The company also pointed out in the announcement that the approval of clinical trial of Jiahe biology "recombinant anti-tumor necrosis factor - α all human monoclonal antibody injection" in Korea will not affect the company's recent performance.