TuNEX® is Mycenax’s etanecept, biosimilar version of Enbrel®.
Its structure comprised of human tumor necrosis receptor (TNFR) 75 and human IgG1 Fc.
Such structure of fusion protein allows it to bind tumor necrosis factors (TNFs) and consequently inhibit the cascade inflammation induced by free TNFs. Therefore, it can alleviate the inflammatory symptoms by rheumatoid arthritis (RA), and reduces the pain, uncomfort and joint deformities of the one suffered from the repeated inflammation.
Etanercept is the leading biologics in the market of human medicinal product. It is indicated for moderate to severe RA, moderate to severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and moderately to severely active polyarticular juvenile idiopathic arthritis. It has specific therapeutic target and provide excellent therapeutic effect. Compared to many other anti-TNFα biologics, it not only furnished better safety, but also prevented disease from deterioration and the impact on daily routine. Thus, it brings life quality back to the patients.
The development of TuNEX® followed the regulatory pathway of both biosimilar and bionovel, and ICH regulations. This project is granted by Ministry of Economic Affairs (MOEA) and selected as the critical path project by Center for Drug Evaluation (CDE) in Taiwan.
Now TuNEX®’s phase III clinical study is ongoing and to be completed in 2016. The market approval will be obtained first in Taiwan and then go global stepwise.