China-based pharmaceutical company Huadong Medicine Co., Ltd (SHE: 000963) has announced a significant milestone with the issuance of the first national prescription for its biosimilar drug, SaiLeXin, at the Peking University People’s Hospital. This marks a new chapter in the treatment of autoimmune diseases in China, offering patients an alternative to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab).
Stelara and Its Impact
Stelara, developed by J&J, is recognized as the world’s first all-human “dual-targeted” inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23). It has been approved for five indications 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, marking its global expansion.
SaiLeXin: A Promising Biosimilar
SaiLeXin, Huadong Medicine’s biosimilar to Stelara, was recently approved for marketing in China to treat moderate to severe plaque psoriasis. Demonstrating efficacy and safety comparable to Stelara in Phase III studies, SaiLeXin offers a fully human IgG1 monoclonal antibody with a lower immunogenicity risk. The drug’s dosing regimen, requiring only four doses per year during maintenance, promises long-term clinical remission, enhancing patient convenience and compliance.-Fineline Info & Tech
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