China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced that it has received orphan drug designation (ODD) from the US FDA for its interleukin-36 receptor monoclonal antibody (mAb) HB0034. This designation highlights the drug’s potential as a treatment for generalized pustular psoriasis (GPP).
Mechanism of Action and Broader Implications
HB0034 is designed to specifically bind to the IL-36 receptor, effectively blocking IL-36 inflammatory pathway signals. This action leads to a reduction in the release of inflammatory factors that are responsible for various inflammatory diseases and skin disorders, including generalized pustular psoriasis, inflammatory bowel disease, systemic lupus erythematosus, and fibrosis.
Competitive Landscape
The approval of HB0034 comes at a time when similar products are making strides in the market. Boehringer Ingelheim’s BI655130 (spesolimab) received marketing approval in both the US and China last year. Additionally, AnaptysBio’s ANB019 (imsidolimab) is currently in the Phase III clinical trial stage, indicating a competitive landscape for treatments targeting IL-36R.-Fineline Info & Tech
