EirGenix
EirGenix is a Taipei-based biopharmaceutical CDMO and biosimilar developer operating two Taiwan cGMP facilities, offering mammalian and microbial biologics manufacturing, ADC services, and a HER2 biosimilar portfolio licensed globally to Sandoz.
- Company typePublic
- Founded2012
- HeadquartersTaipei, Taiwan
- Headcount101–250
- GTM typeB2B
- OfferingServices
What EirGenix does
EirGenix, Inc. is a Taipei-based biopharmaceutical company operating two business units: a contract development and manufacturing organization (CDMO) and a biosimilar product development unit. The CDMO business provides end-to-end services including cell line development, upstream and downstream process development, analytical and quality control, cGMP mammalian manufacturing (CHO-based, 50L to 2,000L single-use bioreactors), cGMP microbial fermentation (E. coli and Pichia pastoris, 20L to 1,500L), and integrated antibody-drug conjugate (ADC) and bioconjugate services through a strategic partnership with Formosa Laboratories for high-potency payloads. EirGenix serves pharmaceutical and biotech clients globally and operates two cGMP-certified facilities in Taiwan (Xizhi for pre-clinical/pilot work, Zhubei for late-stage clinical and commercial supply) with combined annual antibody output capacity of up to 1,000 kg and 12 x 2,000L single-use bioreactors in Zhubei.
The proprietary product business is built around HER2-targeted biosimilars, anchored by the approved EG12014 Trastuzumab biosimilar (EIRGASUN/HERWENDA), which received Taiwan FDA approval in 2023 and European Commission marketing authorization in November 2023, and EG1206A Pertuzumab biosimilar, which received Phase III trial waivers from FDA/EMA in 2025. The broader pipeline includes ADC biosimilars (Kadcyla and Enhertu analogues), Phesgo and Atezolizumab biosimilars, a CD38 daratumumab biosimilar, a recombinant human hyaluronidase (rHuPH20), and supporting platform products such as CRM197 and HRV3C Protease. The technology platform extends to the licensed HiCB continuous bioprocessing system from Transcenta and proprietary cell line capabilities across CHO-K1, CHO-S, CHO-DG44, CHO-C, CHOZN, NS0, HEK293, PER.C6, and Hybridoma lines.
EirGenix generates revenue through three primary streams: (1) CDMO service fees for development and manufacturing engagements billed to pharma/biotech clients, (2) one-time biosimilar product supply revenues routed through licensing partners, and (3) licensing-related inflows including upfront payments, milestone payments, and ongoing profit-share or royalty arrangements with commercialization partners, most notably the global exclusive deals with Sandoz AG covering EG12014 (signed April 2019) and EG1206A (signed November 2025) for all territories outside Taiwan and selected Asian markets. Pricing is quote-based and not publicly disclosed. The company is publicly traded on Taiwan's TPEx under ticker 6589 and had NT$1,005 million (approximately US$31 million) of revenue in 2025.
EirGenix firmographics
Firmographics- Name
- EirGenix
- Legal name
- EirGenix, Inc.
- Website
- https://eirgenix.com
- Company type
- Public
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- EirGenix is a Taipei-based biopharmaceutical CDMO and biosimilar developer operating two Taiwan cGMP facilities, offering mammalian and microbial biologics manufacturing, ADC services, and a HER2 biosimilar portfolio licensed globally to Sandoz.
- Ownership category
- akta.pro rank
EirGenix industry classification
Industry- Product category
- Biopharmaceutical CDMO & Biosimilar Development
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)
- akta.pro secondary industries
- mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA) (HLAGAGAC), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)
Keywords
Where EirGenix is headquartered
LocationHeadquarters
- HQ city
- Taipei
- HQ country
- Taiwan
- HQ region
- Asia
Offices3 records
Markets served
EirGenix business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales
Revenue model
- CDMO Services: Contract development and manufacturing organization providing end-to-end services from cell line development to commercial-scale GMP manufacturing of biologics for pharmaceutical and biotech clients. Revenue derived from service fees across mammalian and microbial platforms.
- Biosimilar Product Sales: EirGenix develops and manufactures proprietary biosimilar products including Trastuzumab (EIRGASUN/HERWENDA) which has received marketing authorization. Products are commercialized through partners in global markets.
- Licensing Royalties and Milestones: Upfront payments, milestone payments, and ongoing royalties from licensing agreements with pharmaceutical partners. Notable deals include up to USD 152 million from Sandoz for EG1206A plus profit sharing upon launch.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels7 records
EirGenix product offering
Product offeringCore offering
EirGenix is a biopharmaceutical CDMO providing end-to-end contract development and manufacturing services for biologics — including cell line development, process development, analytical and quality control, cGMP manufacturing (mammalian CHO and microbial E. coli/Pichia systems), and ADC and bioconjugate services — from pre-clinical through commercial scale. The company also develops biosimilars (notably HER2-targeted Trastuzumab and Pertuzumab biosimilars), which are commercialized globally through licensing partnerships with companies such as Sandoz AG. Two cGMP manufacturing facilities in Taiwan (Xizhi and Zhubei) hold regulatory approvals from US FDA, EMA, PMDA, TFDA, and TGA.
Product overview
EirGenix operates as a biopharmaceutical CDMO and biosimilar developer with two distinct business units: a CDMO unit providing contract development and manufacturing services, and a Product Development unit focused on biosimilars. The CDMO services include Cell Line Development, Process Development, Analytical & Quality Control, cGMP Manufacturing (both mammalian and microbial systems), and ADC & Bioconjugates services. The product pipeline comprises HER2-targeted biosimilars including EG12014 (EIRGASUN®/HERWENDA® Trastuzumab, commercially available), EG1206A (Pertuzumab, Phase III waived), and several ADC biosimilars (EG12043 Kadcyla, EG12170 Trastuzumab-deruxtecan), plus supporting platform products (HRV3C Protease, CRM197). The company operates two cGMP-compliant facilities in Taiwan (Xizhi and Zhubei) with combined mammalian capacity of twelve 2,000L single-use bioreactors.
Differentiator
Problem solved
Functional benefit
Products and services
- EIRGASUN/HERWENDA (EG12014) Trastuzumab Biosimilar A Trastuzumab biosimilar approved for treatment of HER2-positive early-stage breast cancer, metastatic breast cancer, and gastric cancer. Marketed in Taiwan under the EIRGASUN® brand and licensed to Sandoz globally (excluding Taiwan, China, Russia, and certain Asian countries) under HERWENDA®. Intended for healthcare providers treating HER2-positive cancers.
- Cell Line Development Services Comprehensive cell line development services from DNA to stable producer cell lines for mammalian (CHO-K1, CHO-S, CHO-DG44, HEK293) and microbial (E. coli, Pichia) systems. Generates high-productivity cell lines within 19 weeks for mammalian systems. Served to pharmaceutical and biotech clients building biologics programs.
- Process Development Services End-to-end process development services covering upstream and downstream processing. Upstream capabilities include media screening and feeding optimization for mammalian (3L–50L) and microbial (2L–20L) systems; downstream includes chromatography, ultrafiltration, and lyophilization. Supports pre-clinical to commercial readiness.
- Analytical & Quality Control Services Comprehensive analytical services supporting biopharmaceutical development through GMP manufacturing, including method development, validation, protein characterization, and release testing using SEC-HPLC, SPR, cell-based assays, and LC/MS/MS. Serves CDMO clients requiring release and characterization support.
- cGMP Mammalian Manufacturing cGMP manufacturing services for monoclonal antibodies, bispecific/trispecific antibodies, and ADCs using CHO cells. Facilities include 50L–2,000L single-use bioreactors and stainless steel bioreactors across the Xizhi (~10,000 sq ft) and Zhubei facilities with up to 1,000 kg annual antibody production capacity per line. Served to global pharma/biotech CDMO clients.
- cGMP Microbial Manufacturing cGMP microbial fermentation services using E. coli and Pichia expression systems. Xizhi facility supports 20L–1,000L fermentation; Zhubei facility supports 30–1,500L scale-up. Capabilities include inclusion body processing and soluble protein manufacturing. Served to clients producing recombinant proteins, enzymes and plasmid DNA.
- ADC & Bioconjugates Services Integrated ADC development and manufacturing services including monoclonal antibody development, high-potency chemical manufacturing (via strategic partner Formosa Laboratories), linker technology, and conjugation. Supports both cytotoxic and non-cytotoxic conjugates from small-scale (50–250g batches) to large-scale (1.5–3.0 kg batches). Served to oncology drug developers.
- HRV3C Protease Human Rhinovirus 3C protease available in GMP-grade and R&D-grade for precise removal of affinity tags from recombinant proteins under mild reaction conditions. Used in protein purification and structural studies. Targeted at biologics R&D and manufacturing groups.
- CRM197 Cross Reacting Material 197, a non-toxic mutant of diphtheria toxin used as a vaccine carrier protein and for targeted cancer therapy applications. US FDA DMF Number available. Targeted at vaccine developers and oncology researchers.
- EG1206A Pertuzumab Biosimilar A second-generation HER2-targeted monoclonal antibody biosimilar targeting Perjeta® (Pertuzumab) for HER2-positive breast cancer. Achieved Phase III trial waiver from FDA/EMA in October 2025, enabling accelerated regulatory pathway. Licensed to Sandoz AG for global commercialization (excluding Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, Philippines, and Japan) under a deal valued up to USD 152 million plus profit sharing.
Quantifiable outcome
- HiCB platform delivers 10-15 fold productivity increase and reduces cost of goods by at least 50% compared to conventional fed-batch processes
- +3 more outcomes
Companies that use EirGenix
Customer profileNamed customers1 record
Segments2 records
Ideal customer profiles2 records
EirGenix technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
EirGenix partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core.
- Transcenta TherapeuticscoreStrategic collaboration and non-exclusive licensing agreement granting EirGenix access to Transcenta's Highly Intensified Continuous Bioprocessing (HiCB) platform including continuous perfusion and integrated hybrid continuous purification technologies. EirGenix plans to apply the HiCB platform to serve its CDMO clients pursuing intensified and continuous manufacturing solutions. Transcenta receives upfront, milestone, and future royalty payments.
- Sandoz AGcoreSecond global exclusive licensing agreement for commercialization of EG1206A (Pertuzumab biosimilar), covering all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, Philippines, and Japan. EirGenix receives up to USD 152 million in upfront and milestone payments plus profit sharing upon launch. EirGenix responsible for development and manufacturing.
- Sandoz AGcoreGlobal commercialization agreement for EG12014 (Trastuzumab biosimilar in both 150mg and 420mg formulations). EirGenix responsible for development and manufacturing; Sandoz holds commercialization rights for global markets excluding Taiwan, China, Russia, and certain Asian countries. Product has received EC approval and is under FDA BLA review.
- Formosa LaboratoriescoreStrategic partnership for ADC CMC integration services. Formosa Laboratories, a global leader in high-potency drug manufacturing, supplies quality active pharmaceutical ingredients (APIs) for ADCs including linkers and payloads. Combined capabilities provide end-to-end ADC development and manufacturing services.
Scale indicators6 records
Recent moves10 records
Expansion highlights6 records
EirGenix competitors and assessment
Company assessmentDirect peers
- AGC Biologics: Global biologics CDMO offering mammalian and microbial manufacturing services across multiple sites. Direct competitor for mAb and recombinant protein CDMO contracts with similar regulatory certification profile and therapeutic focus areas.
- Samsung Biologics: Asian-headquartered biologics CDMO with large-scale mammalian manufacturing capacity serving global pharma clients. Directly comparable to EirGenix in CDMO service offering, regulatory certifications (FDA/EMA), and target client base of pharma/biotech seeking mAb manufacturing partners.
- WuXi Biologics: Global leader in biologics CDMO with end-to-end capabilities from cell line development to commercial manufacturing. Direct competitor in mammalian cell culture CDMO services, targeting the same pharma/biotech client base for mAb, bispecific, and recombinant protein manufacturing.
- Lonza Group: Global biologics CDMO with mammalian and microbial platforms supporting pre-clinical through commercial supply. Direct peer in biologics CDMO services targeting pharma clients, with comparable GMP certifications and large-scale bioreactor capacity.
- Boehringer Ingelheim BioXcellence: Biologics CDMO division of Boehringer Ingelheim providing process development and GMP manufacturing for mAbs, recombinant proteins, and biosimilars. Competes directly for biosimilar development and manufacturing partnerships with similar end-to-end service model.
Emerging players
- Polpharma Biologics: European biosimilar developer with integrated development and manufacturing capabilities. Comparable biosimilar-focused business model and strong technical leadership, with overlapping therapeutic area focus including oncology biosimilars.
- Mycenax Biotech: Taiwan-based biologics CDMO offering mammalian and microbial contract manufacturing services. Regional competitor with similar focus on mAb and recombinant protein manufacturing for global pharma clients, sharing Asia-Pacific customer base.
- Celltrion: Korean biosimilar developer with integrated manufacturing capabilities, similar business model combining biosimilar product development with in-house CDMO-like capacity. Comparable in HER2 biosimilar focus (Celltrion has its own biosimilar franchise) and Asian-headquartered biologics manufacturing footprint.
Broad incumbents
- Catalent: Large diversified CDMO with biologics capabilities among broader service offerings. Overlaps with EirGenix in mammalian cell-based biologics manufacturing and cell line development but serves a broader range of modalities and dosage forms.
Others
- Apotex (Apobiologix): Canadian-based generic and biosimilar manufacturer with a biologics division. Comparable biosimilar product development orientation and has produced talent (Klaus Martin) familiar with EirGenix's organizational model and biosimilar commercial strategy.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
EirGenix social profiles
Digital presenceEirGenix compliance and trust
Trust signalCompliance6 records
EirGenix financial estimates
Financial estimateRevenue estimate
Valuation estimate
EirGenix leadership team
Management profileNumber of profiles
Profiles9 records
EirGenix subsidiaries and ownership
Company hierarchySubsidiaries1 record
EirGenix funding detail
Funding detailFunding overview
Funding rounds4 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
EirGenix M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about EirGenix
What does EirGenix do?
EirGenix is a biopharmaceutical CDMO providing end-to-end contract development and manufacturing services for biologics — including cell line development, process development, analytical and quality control, cGMP manufacturing (mammalian CHO and microbial E. coli/Pichia systems), and ADC and bioconjugate services — from pre-clinical through commercial scale. The company also develops biosimilars (notably HER2-targeted Trastuzumab and Pertuzumab biosimilars), which are commercialized globally through licensing partnerships with companies such as Sandoz AG. Two cGMP manufacturing facilities in Taiwan (Xizhi and Zhubei) hold regulatory approvals from US FDA, EMA, PMDA, TFDA, and TGA.
Is EirGenix a public or private company?
EirGenix is a public company. It is classified as public and is currently operating.
When was EirGenix founded?
EirGenix was founded in 2012. It employs 101 to 250 people.
Where is EirGenix based?
EirGenix is headquartered in Taipei, Taiwan, in the Asia region.
How does EirGenix make money?
Three revenue lines are on record. CDMO Services are the primary driver. The others are biosimilar Product Sales and licensing Royalties and Milestones.
Who are EirGenix's main competitors?
Direct peers on record are AGC Biologics, Samsung Biologics, WuXi Biologics, Lonza Group and Boehringer Ingelheim BioXcellence. Emerging players are Polpharma Biologics, Mycenax Biotech and Celltrion. Catalent is listed as a broad incumbent. Apotex (Apobiologix) is listed as an others.
Does EirGenix have an API?
No public API is recorded for EirGenix.
What industry is EirGenix in?
EirGenix's product category is Biopharmaceutical CDMO & Biosimilar Development. Its primary akta.pro industry code is HLAGABAC, Biologics (mAbs/Recombinant Proteins) CDMO, with a secondary code of HLAGAGAC, mRNA & Nucleic Acid Manufacturing Services (mRNA/saRNA/Plasmid DNA). Its NAICS code is 325414 and its SIC code is 2836.