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
- Successful Product Launch Track Record
- 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 biopharmceutical manufacturing facities certificated by the U.S. FDA, Taiwan FDA, and Japan PMDA, demonstrating a strong global regulatory track record.
-mammalian and microbial.
The facilities are certified by the U.S. FDA, EMA, PMDA, TFDA, TGA.
-mammalian and microbial.
The facilities are certified by the U.S. FDA, EMA, PMDA, TFDA, TGA.
Product Development
- Since its establishment, EirGenix has been guided by a commitment to sustainable growth, continuously strengthening its capabilities in biologic drug development and manufacturing while actively expanding into global markets. With biosimilars at the core of its R&D efforts, the company possesses key technologies, including cell line development, and large-scale manufacturing capabilities using mammalian cell and microbial systems. These capabilities enable EirGenix to integrate upstream and downstream process development, clinical trials, marketing authorization applications, and GMP commercial-scale manufacturing.
- Building on its strong expertise in biologic drug development, core technologies, comprehensive regulatory strategies, and GMP commercial-scale manufacturing capabilities, EirGenix is advancing multiple biosimilar development programs. Over the next ten years, the company aims to launch a new product every 12 to 18 months, continually expanding its biosimilar portfolio.
- Through product licensing, co-development, and regional partnerships, EirGenix will combine its R&D and manufacturing capabilities with the market strengths of its global partners to further expand its international presence and provide patients with high-quality, affordable treatment options.
HER2-Positive Breast Cancer Biosimilar Pipeline
Driven by global patient needs, EirGenix is developing a HER2-focused biosimilar pipeline for breast cancer. Its development programs include trastuzumab and pertuzumab biosimilars, subcutaneous combination formulations, and antibody-drug conjugate (ADC) biosimilar candidates. Together, these programs reflect EirGenix's continued development of HER2-targeted biologics across multiple therapeutic approaches.
The Global R&D Milestone of EG12014
Balancing R&D innovation with stable operations, EirGenix's first launched flagship product is EG12014, a Trastuzumab biosimilar for the treatment of breast cancer. EG12014 has successfully completed global clinical trials, and the data confirms its high bioequivalence to Herceptin® produced by the originator Roche, making EirGenix the first biotechnology company in Taiwan to complete Phase III clinical trials for a biosimilar in Europe. We are committed to pushing it onto the international stage, providing patients with a new treatment option that features both top-tier quality and affordability.
Concurrently, we have launched a deep layout for breast cancer indications, including Pertuzumab EG1206A, another HER2 targeted drug with a different mechanism of action, implementing efficient product lifecycle managemen.
Targeting ADC and Immuno-Combination Therapies to Breakthrough Tumor Drug Resistance
Faced with the challenges of clinical drug resistance, combination therapy has become a global biomedical trend. EirGenix precisely targets the combination potential of ADC biosimilars with immune checkpoint inhibitors (such as Atezolizumab) or specific targeted drugs (such as Daratumumab).
In addition to accelerating the R&D of ADC biosimilars, we have proactively mapped out key immuno-oncology biologics that are about to face patent cliffs. By positioning ourselves ahead of time for these key drugs with high medical needs, EirGenix will continue to deepen its international market competitiveness in the field of cancer treatment.