China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been approved by the National Medical Products Administration (NMPA) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.
Humira and JunMaiKang Profile
Humira was first approved in the US in 2002 and entered the Chinese market in 2010. JunMaiKang is the seventh adalimumab biosimilar to be approved in China. The drug was the focus of partnership agreements between Junshi and Mabwell in August 2017 and November 2020, when the two companies established an equally-shared joint venture to act as the Marketing Authorization Holder (MAH) for the drug. JunMaiKang was previously approved to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis in March 2022.
Regulatory and Market Context
The approval of JunMaiKang by the NMPA for additional indications underscores Junshi Biosciences’ commitment to expanding its presence in the auto-immune disease treatment market. This move further solidifies Junshi’s position as a leading developer of biosimilar therapies, offering patients a broader range of treatment options.-Fineline Info & Tech
