Taiwan, May 2 2017 – EirGenix, Inc. (EirGenix), a biotech company operating two business units focused on biosimilar development and CDMO business, today announced that its lead biosimilar product, EG12014 (trastuzumab biosimilar), has reached bioequivalence in the primary endpoint assessment compared to Roche product Herceptin® from EU and the US after data un-blinding for the Phase 1 clinical trial.
This Phase 1 clinical trial (Study No.: EGC001) is a double-blind, randomized, parallel group, 3-arm study, where a total of 84 male healthy volunteers were enrolled. The study was conducted in Europe. The objective of this study was to investigate the pharmacokinetic similarity between EG12014 and the reference products, Roche produced Herceptin® sourced from EU and the US. The results of primary endpoint assessments indicated that bioequivalence was observed between EG12014 and Herceptin® from EU and the US.
EirGenix is currently preparing to initiate the Phase 3 global study of EG12014. The study will enroll approximately 800 early breast cancer patients, and will be performed globally in more than 20 countries including the US and main European countries. The design of this Phase 3 study, along with the regulatory strategy of EG12014 biosimilar program, will be discussed in the regulatory meetings with the EMA and FDA in Q2-Q3, 2017. In parallel, EirGenix is actively exploring regional and global partnerships for further development and commercialization.
EirGenix has embarked on the construction of a new commercial manufacturing facility in Zhubei Biomedical Science Park, Taiwan since December, 2016. The new commercial facility will start operation in 2018, and is equipped with the state-of-the-art 2,000 L Single-Use Bioreactor (SUB) system. It has two production lines, each production line can be expanded to 3 sets of 2 x 2000 L, enabling a maximum annual capacity of 500 kg. The new Zhubei facility will support the commercial manufacturing of EG12014 while providing global manufacturing services.
EirGenix has been developing biosimilar products according to global regulatory standards. The Phase 1 clinical trial for EG12014 is the first biosimilar Phase 1 trial completed by a Taiwanese company in Europe, performed in compliance with EMA and FDA biosimilar regulations. EirGenix will continue to develop biosimilar products at the highest quality standard, and aim to commercialize the first biosimilar product manufactured in Taiwan for the global market.