Lynk Pharmaceuticals Co., Ltd. and Simcere announced a strategic partnership to develop and commercialize a highly selective JAK1 inhibitor LNK01001 in China. Under the terms of the agreement, Lynk Pharmaceuticals is responsible for the development of the product. Simcere will obtain the exclusive rights to market LNK01001 for the indications of rheumatoid arthritis and ankylosing spondylitis in China, after completing the payment of all commercialization rights and interests.
JAK1 belongs to an important subgroup of the cytosolic tyrosine kinase Janus kinase (JAKs) family that is closely related to the pathogenesis of various autoimmune diseases. 6 head-to-head clinical studies have demonstrated the huge clinical potential of selective JAK1 inhibitor as an emerging new treatment of rheumatoid arthritis, with significant advantages over methotrexate and several biological agents. Published data of JAK1 inhibitor as treatment of ankylosing spondylitis have shown sufficient superiority of JAK1 inhibitor in a head-to-head study over Humira, the TNFa targeting blockbuster. Selective JAK1 inhibitors are thus considered to be the next superstar of therapies.
LNK01001 is a highly selective JAK1 inhibitor with therapeutic potential for various autoimmune diseases. Clinical trials in Chinese and western patient groups are being carried out, including phase II studies in China in three indications of rheumatoid arthritis, ankylosing spondylitis, and atopic dermatitis. Previously, LNK01001 has completed Phase I clinical studies in healthy subjects in China and Australia. The results of preclinical data show that LNK01001 has higher selectivity and potentially better safety than other marketed JAK inhibitors. It is expected to provide patients with newer, safer and more effective treatment options.