Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab), named SaiLeXin. This development marks a significant step forward in providing treatment options for adult patients with moderate to severe plaque psoriasis in China.
Stelara’s Unique Positioning and Indications
Stelara is recognized as the world’s first all-human “dual-targeted” interleukin 12 (IL-12) and interleukin 23 (IL-23) inhibitor. Johnson & Johnson has secured five indication approvals for Stelara in the US, including ulcerative colitis, Crohn’s disease, active psoriatic arthritis, and psoriasis, in addition to plaque psoriasis. Stelara was first approved in China in 2017, expanding its global reach.
Partnership for Development and Commercialization
Huadong Medicine struck a partnership with Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509) in August 2020 to jointly develop and commercialize SaiLeXin in mainland China. This collaboration includes the co-advancement of the Phase III clinical study for the drug, highlighting the commitment of both companies to bringing this biosimilar to the Chinese market.- Flcube.com
