ABOUT EIRGENIX

"Clients' 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

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 remarkable growth in sales and broke even in 2016. EirGenix Zhubei facility officially operated in 2019 and Xizhi facility received Japan PMDA approval in 2020, which increased business growth and triggered an indication of the trust from domestic and foreign clients for 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.

Achieving Mutual Growth with Clients

To meet the growing demands and to bring mutual growth for EirGenix and clients, our new GMP plant situated in the Zhubei Biomedical Park officially in 2019. In the first stage, one production line was established at our Zhubei GMP with two 1,000-liter and six 2,000-liter single use bioreactors. In current expansion stage, additional production line is expected to be in operation by mid-2023, which will bring our capacity to the maximum twelve 2000-liter single use bioreactors, and the maximum annual production capacity of antibody can reach 1,000 kg. 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 US FDA, Taiwan FDA and Japan PMDA.

Product Development

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 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 received successful results in Phase III clinical trials and is in the regulatory filling stage. 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 is 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, as well as involving another mechanism for treatment targeting HER2 protein (EG1206A). 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.