Core Viewpoint - Company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Qletli (BAT1406), a biosimilar of adalimumab, which is expected to enhance the company's international market presence and positively impact long-term operational performance [1] Group 1 - Qletli (BAT1406) is a fully human monoclonal antibody developed by the company, expressed in CHO cells, that specifically binds to and neutralizes TNF-α, blocking its inflammatory effects [1] - The approval allows the company to expand its product offerings in the UK market, thereby increasing its international influence [1] - The drug is indicated for various adult conditions including rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, among others [1] Group 2 - Pediatric indications for Qletli include juvenile idiopathic arthritis, pediatric plaque psoriasis, and pediatric Crohn's disease [1] - The approval is expected to have a positive impact on the company's long-term business performance [1]
百奥泰:Qletli®(阿达木单抗注射液)获得英国MHRA上市批准