About EirGenix

Client's Success is Our Priority

For EirGenix Inc., health is important for all people. Under this belief, EirGenix established two business units to achieve the goal. One is contract development and manufacturing operation unit where EirGenix helps clients to manufacture their biologics; the other is the product development operation unit where we hope to fully apply our team's experience and knowledge on biologics from biosimilars, biobetters to new drugs. EirGenix's goal is that every patient can afford high-quality biopharmaceutical drugs.

Contract Development and Manufacturing Operations (CDMO) Unit

In March 2013, EirGenix undertook the two cGMP pilot plants—one for mammalian cell and one for microbial—as well as the outstanding DCB technicians. With the predecessors' accumulated experiences as the starting point, EirGenix managed to quickly gain a steady foothold. The dedicated efforts of the general manager and the professionals formed a strong technical and management team. In four years, EirGenix has achieved 28-fold growth in sales and broke even in 2016. The steady sales growth is an indication of the trust that domestic and foreign clients' have in EirGenix's skills and operations. Our team has helped our clients move faster and further through our professional experiences and knowledge. Successfully developed medicines provide everyone an extra level of protection in health; thus, the success of our clients in developing a medicine is our priority.

Product Development and Operations Unit

EirGenix currently has seven products undergoing development. Four antibody products are for treating HER2 gene variance; one antibody biosimilar is for inhibiting angiogenesis, and one carrier protein is for vaccination use.

Antibody Products for Treating HER2 Gene Variance

EirGenix accounted for the risks and operational stability and developed its first product. Code named EG12014, this biosimilar is the antibody drug, trastuzumab, and is used to treat breast cancer. With the team's knowledge and efforts, EG12014 has completed EU Phase I clinical trial and is considered bioequivalent to Roche's blockbuster, Herceptin®. EirGenix has become the first biotech company in Taiwan to have completed biosimilar clinical trials in EU. At present, EG12014 is carrying out Phase III clinical trials with 800 human subjects from multiple countries and centers. We hope that EG12014 will provide breast cancer patients with an affordable therapeutic drug alternative that is the same quality as the best, because we believe that the health of these patients are our top priority.

Starting with EG12014, EirGenix continued R&D for a series of products treating breast cancer, including new formulation (EG13074), ADC products that binds small molecules (EG1104X), as well as involving another mechanism for treatment targeting HER2 protein (EG1206X). From this, we want to not only manage the lifecycle of each product more effectively; but also provide comprehensive assistance for HER2-positive breast cancer patients during their treatment process.

Antibody Biosimilars for Inhibiting Angiogenesis

EirGenix also developed biosimilar EG12021 for resisting tumor angiogenesis, and EG12021 uses anti-angiogenesis as mechanism, allowing it to be used for treating other solid tumor indications as well.

Carrier Protein for Vaccination Use

An ounce of prevention is worth a pound of cure. Vaccines play an important role in epidemic diseases and even cancer prevention. However, it often requires good carrier proteins to trigger immune responses and fight pathogens of the R&D of vaccine. As a safe and effective carrier protein, EG74032 is the best partner for the development of a variety of vaccines; working together to prevent the onset of various diseases, prevent discomfort of disease-induced patients, and reduce medical expenses.

Achieving Mutual Growth with Clients

As the biologics developed by EirGenix and its clients gradually enter Phase III of clinical trials and/or new drug launch, EirGenix must expand its manufacturing capacity. This is to meet the growing demands and to bring mutual growth for EirGenix and its clients. In December 2016, the new plant situated in the Zhubei Biomedical Park broke ground. There are various stages of constructions for the new plant: Stage I includes the constructions of infrastructures and mammalian cell PIC/S GMP plant. Taking into account the utilization of capacity and the flexibility of future expansion, EirGenix will first set up two 2000-liter single use bioreactors. The reserved spaces and pipelines can be expanded to the maximum twelve 2000-liter single use bioreactors, and the maximum annual production capacity of antibogy can reach 1000kg. The new plant is expected to officially commence production in the second half of 2018. With the state of the art equipment and the most experienced technical team, Eirgenix will bring maximum benefits to clients and patients. Client's success and public health are our priorities.

Our History Leads to Our Future

EirGenix, Inc. (6589) was founded on December 21st, 2012. In mid-March, 2013, EirGenix, Inc., Formosa Laboratories, Inc., and Development Center for Biotechnology (DCB) signed a joint venture agreement. EirGenix Inc. obtained the rights to operate the cGMP biopharmaceutical pilot plant facility and completed the transfer of all technologies, R&D, and production personnel in April, 2013, while taking over the original pilot plant team's core capabilities, including cell line establishment, large-scale production process development, analytical method development, GMP quality system operations, and two cGMP facilities—one for mammalian cells and one for microbial— that are certified by the Taiwan FDA.

The DCB-cGMP Biopharmaceutical Pilot Plant Facility (DCB-BPPF) was established in 2001 as a consequence of the government wanting to create a cGMP facility, in line with international standards. The plant was to assist domestic biopharmaceutical development companies in R&D by manufacturing drugs, used for animal and human subject clinical trials, which meet quality standards and batch-to-batch consistency. The risk involved in drug development is substantial, and is the main reason that the government sought to build this cGMP facility. Without this government backed facility, a biopharmaceutical development company has to first, invest a considerable amount of money on production plant construction for the drugs without knowing whether or not the drug would be granted safe passage through the clinical trials stage. Then, if the drug falls short of expectations and is denied of entry into the market, the factory will become idle, resulting in inefficient use of funds and wasted resources. With this cGMP plant, the government hopes to reduce the barriers to entry for drug development companies.

In view of this, the government commissioned the DCB in 2001 to construct a cGMP biopharmaceutical facility and establish the basic biopharmaceutical technologies. In December 2005, the DCB obtained cGMP production certification for its mammalian cell plant and began providing related services to domestic and foreign clients. In addition to the mammalian cell expression system, the government re-commissioned the DCB in 2011 to construct a microbial expression system cGMP plant due growing demands from biopharmaceutical new drug development companies. The microbial facility obtained cGMP production certification in January 2013. These two cGMP plants, with differing expression systems, provided clients with biological production services in line with international standards.

Since beginning its industrial services in 2005, the cGMP biopharmaceutical plant team has continually assisted domestic clients in accelerating biopharmaceutical drug development progress and in acquiring the IND approval from regulatory authorities (such as Taiwan FDA, US FDA, EMA, and Health Canada) to enter clinical trials. In 2010, as the cGMP biopharmaceutical plant operations matured, the government started thinking to make it an independently operating company that will no longer rely on government subsidies. After a series of biddings, assessments, and reviews, the team formed by EirGenix, Inc. and Formosa Laboratories, Inc. finally obtained the priority agreement rights. They signed the joint venture agreement with the DCB in March. EirGenix, Inc. obtained the rights to operate the cGMP Biopharmaceutical plant.