Biotech (688177.SH): Gotenfia® (golimumab injection) received positive opinions from the European Medicines Agency's Human Medicines Committee

Zhitong Finance App News, Biotech (688177.SH) issued an announcement. The company recently received a notice from the European Medicines Agency (“EMA”), and Gotenfia® (BAT2506, golimumab injection) received positive opinions from the EMA Human Drugs Commission (hereinafter referred to as “CHMP”). The CHMP recommended that the European Commission (EC) approve the marketing of Gotenfia® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis.

BAT2506 is a golimumab biosimilar developed by Biotech in accordance with the relevant guidelines of the China National Drug Administration (“NMPA”), the US Food and Drug Administration (“FDA”), and the EMA biosimilar. Golimumab is an antibody targeting TNF-α. It can specifically bind soluble and transmembrane human TNF-α with high affinity, block the binding of TNF-α to its receptor TNFR, thereby inhibiting the activity of TNF-α.

The original drug for BAT2506 (golimumab injection) was Simponi® (Simponi®) from Johnson & Johnson of the United States. According to Johnson & Johnson's 2024 annual report, Simponi® had global sales of $2.119 billion in 2024.