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

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.
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EirGenix, Inc.
www.eirgenix.com
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