Qletli (阿达木单抗注射液)
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百奥泰:Qletli (阿达木单抗注射液)获得英国MHRA上市批准
Zhi Tong Cai Jing· 2025-09-10 08:21
Core Viewpoint - The company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its product Qletli (BAT1406, Adalimumab injection) [1] Group 1: Product Development - Qletli is a biosimilar of Adalimumab developed independently by the company, expressed in CHO cells as a recombinant fully human monoclonal antibody [1] - The mechanism of action involves specific binding to TNF-α, neutralizing its biological function, and blocking its interaction with cell surface TNF-α receptors, thereby inhibiting the inflammatory effects of TNF-α [1] Group 2: Market Impact - With the approval from the UK MHRA, the company can now sell Qletli in the UK, expanding its overseas product offerings [1] - This approval is expected to enhance the company's international influence and positively impact its long-term operational performance [1]