On 26 October 2026, Bio-Thera Solutions announced that it has received marketing authorisation from China’s National Medical Products Administration (NMPA) for BAT2306 (marketed as Youzhuomei™), biosimilar to Novartis’ Cosentyx® (secukinumab). BAT2306/Youzhuomei™ is the first biosimilar secukinumab approved in China. According to Bio-Thera, it is also the first biosimilar secukinumab approved by any major regulatory agency in the world.
BAT2306/Youzhuomei™ is approved for psoriasis, ankylosing spondylitis and psoriatic arthritis. Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.
Bio-Thera completed a phase 3 clinical trial of BAT2306 in plaque psoriasis in 2024, and a phase 1 trial in 2023. It has signed commercialisation agreements for BAT2306 with multiple partners, including Pharmapark in Russia (August 2024), Jamjoon Pharmaceuticals in Middle East and North Africa (September 2025), and Dr Reddy’s in Southeast Asia (November 2025).
Secukinumab biosimilars are also under development by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting). In June 2026, CSPC Pharmaceutical announced that China’s NMPA had accepted for review a marketing authorisation application for its Secukinumab Injection.