百奥泰生物制药股份有限公司关于GotenfiaR（戈利木单抗注射液）获欧洲EMA上市批准的公告

Group 1 - The core announcement is that Baiotai Biopharmaceutical Co., Ltd. has received marketing approval from the European Medicines Agency (EMA) for GotenfiaR (BAT2506, Golimumab injection) [1][2] - GotenfiaR is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis [2] - BAT2506 is a biosimilar developed according to guidelines from the National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA), and EMA, targeting TNF-α to inhibit its activity [2] Group 2 - The marketing authorization application for BAT2506 has been accepted by NMPA, FDA, and Brazil's National Health Surveillance Agency, with commercialization partnerships covering 115 countries and regions [2] - The approval of GotenfiaR is expected to enhance the company's international market presence and positively impact long-term operational performance [2] - The company acknowledges potential competition from already marketed and other potential competing products, which may have first-mover advantages [2]