On 3 October 2025, Pharmacy Times reported that CSPC Pharmaceutical Group’s SYSA1902 has been shown in a phase 3 study to be clinically equivalent to its reference product, Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis.
The results of the phase 3 study were published in the Journal of the American Academy of Dermatology in April 2025. The results are likely to form the basis for an FDA approval application.
The phase 3 study follows CSPC’s November 2024 announcement that its biologic license application for ustekinumab was accepted by the People’s Republic of China’s National Medical Products Administration. CSPC’s ustekinumab biosimilar was developed by related company CSPC Megalith Biopharmaceuticals.