On December 19, 2017, ICP-022, an innovative pharmaceutics with wholly-owned intellectual property rights, was approved by the State Food and Drug Administration (CFDA) for clinical trials against systemic lupus erythematosus (SLE) and rheumatoid arthritis.
Autoimmune diseases such as SLE and RA are serious threats to human health. More than 2 million Chinese patients still lack effective treatments. ICP-022 is a highly specific BTK inhibitor with excellent efficacy in SLE and RA models. It has shown good tolerance and safety in phase I clinical trial on healthy subjects in Australia. It is expected to provide safe and effective treatment options for patients with SLE and RA.
Dr. Jisong Cui, co-founder, chairman and CEO of InnoCare, said: “The clinical trial of ICP-022 has been approved, which means that the first research product from InnoCare, which was established 2 years ago, will soon enter clinical development in China. The reform of domestic pharmaceutical policy and the steady growth of the pharmaceutical market are crucial to the development of InnoCare. We are very happy to receive this approval and look forward to officially launching the clinical research of ICP-022 in mainland China."
ICP-022 is a highly specific BTK inhibitor with excellent kinase selectivity and drug-like properties. Good safety and pharmacokinetic properties have been shown in clinical trials in Australia. It has good prospects for the treatment of autoimmune diseases.