Jiangsu Hengrui Medicine Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange (SHA: 600276), has announced that the National Medical Products Administration (NMPA) has approved its market filing for vunakizumab, an IL-17A monoclonal antibody (mAb), for the treatment of moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. This marks the first homegrown innovative drug in the autoimmune field in China.
Vunakizumab is indicated for the treatment of autoimmune diseases associated with the IL-17 pathway. The drug contains 0.8% mouse-derived components and retains 6 CDR regions from mouse sources. It features an “innovative binding epitope” that ensures high affinity for IL-17A, allowing for precise binding and efficient targeted blockade of the IL-17A pathway. This results in a rapid onset and high complete clearance rate. The lower mouse-derived components also contribute to reduced potential immunogenicity. Vunakizumab is also under assessment in studies for psoriatic arthritis, adult active ankylosing spondylitis, with preparations for a market filing for the latter indication.
Global IL-17A products include Novartis’s Cosentyx (secukinumab), Eli Lilly’s Taltz (ixekizumab), and Biocad’s Efleira (netakimab). The first two were approved in China within the first batch of clinically urgently needed drugs in April and September 2019, respectively.- Flcube.com
