GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical studies for BAT2406, a biosimilar version of Sanofi’s Dupixent (dupilumab). This monoclonal antibody, which targets interleukin-4 (IL-4) and interleukin-13 (IL-13), is now set to be assessed in a range of conditions including atopic dermatitis, asthma, nodular prurigo, chronic nasal solid inflammation with nasal polyps, and eosinophilic esophagitis.
Developed in accordance with biosimilar guidelines established by regulatory bodies in China, the US, and the European Union, BAT2406 marks a significant milestone as the first biosimilar of its kind in China to be approved for clinical trials. The approval underscores Bio-Thera Solutions’ commitment to advancing biosimilar development and expanding treatment options for patients suffering from various allergic and inflammatory conditions.
The clinical trial approval comes as a testament to the company’s rigorous development process and its potential to offer a more accessible alternative to the original Dupixent, which has been widely recognized for its efficacy in treating moderate-to-severe atopic dermatitis and other related conditions. – Flcube.com
