On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental application for QX001S, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for use in Crohn’s disease. The NMPA has previously approved QX001S for the treatment of moderate-to-severe plaque psoriasis in adults (October 2024) and for use in paediatric plaque psoriasis (December 2024).
Qyuns Therapeutics jointly conducted the R&D and clinical trials for QX001S with Zhongmei Huadong, with QX001S obtaining clinical trial approval in 2018, its Phase I clinical trial completing in 2020, and the Phase III clinical study completing in June 2023.
QX001S was the first ustekinumab biosimilar approved in China, followed closely by CSPC Pharmaceutical Group which announced in November 2024 that its biologic licence application for ustekinumab was accepted by the NMPA.