About EirGenix
Clients’ Success is Our Priority
Two business units. One shared commitment to quality and trust.
- CDMO UnitSupporting global partners in the development and manufacturing of biologics.
- Product Development UnitApplying biosimilar and biobetter experience to strengthen CMC and manufacturing expertise.
CDMO Services
- 30+ Years of Collective Biopharmaceutical Development Experience
- Product Successful Launch Track Records
- Stable Commercial Manufacturing Operations
Achieving Mutual Growth with Clients
EirGenix operates cGMP-compliant manufacturing facilities supporting both mammalian and microbial platforms, enabling flexible biologics production from clinical to commercial supply.
With established commercial manufacturing operations and robust quality systems, EirGenix delivers reliable capacity while maintaining a strong commitment to quality, regulatory compliance, and client success.
With established commercial manufacturing operations and robust quality systems, EirGenix delivers reliable capacity while maintaining a strong commitment to quality, regulatory compliance, and client success.
Our History Leads to Our Future
EirGenix, Inc. (6589) was founded on December 21, 2012, and operates two cGMP-compliant biopharmaceutical manufacturing facilities—mammalian and microbial—certified by the U.S. FDA, Taiwan FDA, and Japan PMDA, demonstrating a strong global regulatory track record.
In 2013, a joint venture with Formosa Laboratories and DCB gave EirGenix operational rights to a cGMP pilot plant and transferred key R&D and production expertise, establishing its core capabilities in cell line and process development and GMP operations.
In 2013, a joint venture with Formosa Laboratories and DCB gave EirGenix operational rights to a cGMP pilot plant and transferred key R&D and production expertise, establishing its core capabilities in cell line and process development and GMP operations.
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.
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.