Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA) has accepted its filing for an additional indication for SaiYueXin, a biosimilar to Johnson & Johnson (J&J, NYSE: JNJ)’s Stelara (ustekinumab). The Chinese pharmaceutical company is now seeking approval for the use of SaiYueXin in children and adolescents aged 6 years and above, weighing between 60 kg to 100 kg, who suffer from moderate to severe plaque psoriasis and have not responded to or are intolerant of other systemic treatments or phototherapy.
Stelara’s Dual-Targeted Inhibition and Market Presence in China
Stelara, the world’s first all-human “dual-targeted” inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23), has been a significant player in the treatment of auto-immune diseases. Since its initial approval in China in 2017, J&J has expanded its marketing authorizations to include adult and pediatric plaque psoriasis, as well as Crohn’s disease.
SaiYueXin’s Development and Initial Approval
SaiYueXin, co-developed with Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509) following an agreement in August 2020, was first approved in China last month. This marks the first biosimilar approval of Stelara in the country, potentially offering a more affordable alternative for patients with plaque psoriasis.-Fineline Info & Tech
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