China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA) has approved another indication for its SaiYueXin, a biosimilar version of Johnson & Johnson’s (J&J) autoimmune disease drug Stelara (ustekinumab). The drug is now approved for use in China to treat children and adolescents aged 6 years and above (weighing 60 kg to 100 kg) with moderate to severe plaque psoriasis who have failed to respond to or are intolerant of other systemic treatments or phototherapy.
Drug Profile
Stelara is the world’s first all-human “dual-targeted” interleukin 12 (IL-12) and interleukin 23 (IL-23) inhibitor. J&J has obtained marketing approvals for the drug to treat adult plaque psoriasis, pediatric plaque psoriasis, and Crohn’s disease in China since its initial approval in 2017. SaiYueXin, co-developed with compatriot firm Jiangsu QYuns Therapeutics Co., Ltd (2509.HK) under a deal signed in August 2020, received its first approval in China last December, marking the first biosimilar of Stelara to be approved in the country. The drug is also awaiting regulatory decisions in China for the treatment of Crohn’s disease, with the approval filing accepted for review by the NMPA last month.-Fineline Info & Tech
