Date: 2016-07-07
Type of information: Submission of a clinical trial application
phase: 1
Announcement: submission of a clinical trial application
Company: Mycenax Biotech (Taiwan)
Product: LusiNEX, biosimilar version of RoActemra® (tocilizumab)
Action
mechanism: monoclonal antibody/biosimilar. Tocilizumab is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: UK
Trial details:
Latest
news: * On July 7, 2016, Mycenax Biotech announced the successful scientific advisory meeting with UK health authority, MHRA, on July 4. The advice of MHRA covered CMC, nonclinical and clinical developments of LusiNEX. LusiNEX is a biosimilar version of RoActemra®, an anti-IL6R monoclonal antibody, which is approved for treating many inflammatory diseases related to IL-6.
LusiNEX is the first Mycenax’s pipeline product designed for global development at the outset. Also, it is the first time Mycenax exposed its own project to the European authority. During the meeting, the authority responded almost 100% positively to the company’s approaches. With MHRA’s feedback, Mycenax is highly confident on the developmental strategy. Since the position and direction is affirmed, Mycenax will embark on clinical development and file for PK study in Q2 of 2017.
