written on 11.02.2019

EirGenix’s cancer therapeutic drug EG12014 (Trastuzumab biosimilar) is approved for phase III clinical trial

TAGS: Taiwan, EirGenix,

Oct. 30, 2018

EirGenix is a biologics development and contract development & manufacturing organization. EirGenix Inc. has formed a strategic alliance with Formosa Laboratories Inc. to provide contract development & manufacturing services of antibody drug conjugates (ADC). This strategic alliance secures both parties’ competitive advantage for ADC components, e.g. monoclonal antibody, linker, and payload (cytotoxic compounds), under a single window. EirGenix provides high quality and cost-effective services supporting our clients in cell line and process development, analytical method development & testing, and manufacturing in cell banking and biologics products in compliant with PIC/S GMP from pre-clinical to commercial manufacturing stages. In addition, EirGenix received official accreditation certificate of foreign drug manufacturer from Japanese authority, which can bring EirGenix’s biological products manufactured in Taiwanese facility to Japan for sale.

EirGenix’s rich pipeline currently has seven products in development whose stage ranging from Pre-clinical to Phase III study in the US, European nations and Asia. EirGenix’s biosimilar drug EG12014 (Trastuzumab biosimilar) has been approved by US Food and Drug Administration (FDA), Russia, Belarus, Ukraine, India, Georgia, South Korea, Chile and Taiwan Food and Drug Administration (TFDA) for Phase III clinical trial. It is estimated to recruit 800 breast cancer patients around the world for the trial, and we had finished the First Patient Enrolled on end of Oct., 2018. According to Roche’s 2017 annual report, Herceptin’s global sales amounted to 7.014 billion Swiss francs. This trial will be a large-scale international one for biosimilar drug in Taiwan in recent years. This trial will also improve the competitiveness of Taiwan in drug development.


EirGenix, Inc.