Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin, a biosimilar version of Johnson & Johnson (J&J)’s auto-immune disease drug Stelara (ustekinumab), has been accepted for review by the National Medical Products Administration (NMPA). The Chinese firm is seeking approval for its use in Crohn’s disease.
Background on Stelara
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 first approval in 2017.
Details on SaiYueXin
SaiYueXin, co-developed by compatriot firm Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509) through a deal in August 2020, was first approved in China in October of last year. It marked the first biosimilar of Stelara to be approved in the country. In addition to the current application for Crohn’s disease, it is also awaiting regulatory decisions in China for the treatment of children and adolescents aged 6 years and above with moderate to severe plaque psoriasis.-Fineline Info & Tech
