China-based Junshi Biosciiences (HKG: 1877, SHA: 688180) has announced that another market approval filing for JunMaiKang, a biosimilar version of AbbVie’s auto-immune disease drug Humira (adalimumab) co-developed by Mabwell, has been accepted by the National Medical Products Administration (NMPA). In addition, the NMPA also accepted a clinical trial filing for Junshi’s JS015, a DKK1 monoclonal antibody (mAb).
JunMaiKang Details
Humira is used to treat Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease. JunMaiKang, the seventh adalimumab biosimilar approved in China, was the focus of partnership agreements between Junshi and Mabwell in August 2017 and November 2020. The two companies set up an equally shared joint venture to act as the Marketing Authorization Holder (MAH) for the drug. It was approved to treat rheumatoid arthritis, ankylosing spondylitis, and psoriasis in March 2022.
JS015 Details
JS015 is a recombinant humanized anti-DKK1 monoclonal antibody (mAb) being developed to treat advanced malignant tumors. Dickkopf-1 (DKK1), a secreted modulator of Wnt signaling, is overexpressed in many cancers including gastric cancer, gastroesophageal junction cancer, myeloma, liver cancer, lung cancer, ovarian cancer, and others. JS015 binds to DKK1 with high affinity, effectively blocking the interaction between DKK1 and its ligand LRP5 / 6, and activates the Wnt signaling pathway. At the same time, JS015 can inhibit the immunosuppressive effect of DKK1 in the tumor microenvironment and enhance the ability of the immune system to kill tumor cells. Preclinical in vivo efficacy studies have shown that JS015, combined with the PD-1 inhibitor toripalimab (trade name: Tuoyi) or paclitaxel, has significant tumor inhibitory effects. Animal experiments show that JS015 is well-tolerated. So far, no similar product has been approved for marketing anywhere in the world.-Fineline Info & Tech
