STgen Bio
STgen Bio (BTGEN) is a South Korea-based biopharmaceutical CDMO in Songdo, Incheon, providing integrated Drug Substance and Drug Product manufacturing services for global pharma and biotech clients' biosimilar and antibody pipelines.
- Company typePrivate
- Founded2015
- HeadquartersIncheon, South Korea
- Headcount51–100
- GTM typeB2B
- OfferingServices
What STgen Bio does
STgen Bio (now operating as BTGEN following a 2026 rebrand) is a South Korea-based biopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in Songdo, Incheon. Founded in 2015 as a joint venture between Dong-A Socio Holdings and Meiji Seika Pharma under the name DM Bio, the company became a wholly-owned subsidiary of Dong-A Socio Holdings in October 2021 when the Korean parent acquired Meiji's 421 billion KRW stake. The company specializes in mammalian cell culture-based manufacturing of antibody biopharmaceuticals and recombinant proteins, operating a single-site cGMP-certified facility in Songdo that delivers integrated Drug Substance (DS) and Drug Product (DP) services including fully automated pre-filled syringe (PFS) filling, analytical testing, and regulatory support.
The core technology platform is a hybrid mammalian cell culture system combining single-use and multi-use bioreactors up to 2,500L scale, paired with chromatography and ultrafiltration/diafiltration downstream processing. Total production capacity is currently 9,000L, with a 1,100 billion KRW (~$800M USD) expansion to 14,000L planned for Q1 2026 through Q1 2028. The company's commercial pipeline is anchored by biosimilars including DMB-3115 (Stelara biosimilar, FDA BLA approved 2024), DA-3880 (Aranesp biosimilar, supplied to Japan via SKK), and ALT-L9 (Eylea biosimilar, manufactured for Alteogen). Concurrent cGMP approvals from the US FDA, European EMA, and Japan PMDA — with Saudi Arabia SFDA and Health Canada inspections underway — position the company as a globally-credentialed CDMO for biosimilar supply chains.
STgen Bio generates revenue through contract manufacturing and development services billed under multi-year project-based agreements, including upfront, milestone, and commercial supply fee components. Reported revenue reached 58.8 billion KRW (~$42.6M USD) in FY2023, up 46% from FY2022's 40.3 billion KRW (~$29M USD). Customer segments include global pharmaceutical companies (Dong-A ST, Meiji Seika, Intas Pharmaceuticals, Alteogen), Korean bioventure and biotech firms served via CRO/CDO partners (Protium Science), and intra-group Dong-A Socio Holdings affiliates. Go-to-market is enterprise field sales supported by participation in major industry events (INTERPHEX, BIO USA, BIOPLUS-INTERPHEX KOREA) and strategic partnerships with contract development and research organizations.
STgen Bio firmographics
Firmographics- Name
- STgen Bio
- Legal name
- BTGEN Co., Ltd.
- Website
- https://stgenbio.com
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- STgen Bio (BTGEN) is a South Korea-based biopharmaceutical CDMO in Songdo, Incheon, providing integrated Drug Substance and Drug Product manufacturing services for global pharma and biotech clients' biosimilar and antibody pipelines.
- Ownership category
- akta.pro rank
STgen Bio industry classification
Industry- Product category
- Biopharmaceutical Contract Manufacturing (CDMO)
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)
- akta.pro secondary industry
- Drug Substance–Drug Product Integrated CDMO (HLAGABAG)
Keywords
Where STgen Bio is headquartered
LocationHeadquarters
- HQ city
- Incheon
- HQ country
- South Korea
- HQ region
- Asia
Offices2 records
Markets served
STgen Bio business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales
Revenue model
- Contract Manufacturing (CMO): Manufacturing biopharmaceuticals (Drug Substance and Drug Product) for pharmaceutical companies under long-term contracts. Revenue is generated through upfront payments, milestone payments, and commercial supply fees.
- CDMO Services: Full-spectrum contract development and manufacturing services including process development, technology transfer, scale-up engineering, and regulatory support
- Commercial Manufacturing Supply: Ongoing supply of commercialized biopharmaceutical products such as DMB-3115, generating recurring revenue from product supply
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based pricing |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels3 records
STgen Bio product offering
Product offeringCore offering
STgen Bio (BTGEN) is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) providing integrated one-stop services from Drug Substance (DS) to Drug Product (DP). The company manufactures antibody-based biopharmaceuticals and recombinant proteins using mammalian cell culture with up to 2,500L bioreactors in a hybrid single-use/multi-use platform, performs fully automated pre-filled syringe filling, and provides analytical testing, regulatory support, and cold chain logistics for global pharmaceutical and biosimilar developers.
Product overview
STgen Bio (BTGEN) is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) offering fully integrated one-stop CMO/CDMO services. The company's core manufacturing operations include DS Manufacturing (Drug Substance) using mammalian cell culture with up to 2,500L bioreactors in a hybrid single-use/multi-use platform, and DP Manufacturing (Drug Product) featuring fully automated pre-filled syringe filling and secondary packaging with serialization. Supporting services include Analytical Testing (physicochemical, microbial, cell-based testing) and a Quality Management System compliant with global regulatory standards. Key products include DMB-3115 (Stelara biosimilar), DA-3880 (Aranesp biosimilar), and ALT-L9 (Eylea biosimilar). The company serves global markets including Korea, Japan, US, and Europe.
Differentiator
Problem solved
Functional benefit
Products and services
- DS Manufacturing (Drug Substance) Mammalian cell culture manufacturing for antibody-based biopharmaceuticals and recombinant proteins, with bioreactors up to 2,500L and a hybrid single-use/multi-use platform for clinical, PPQ, and commercial supply.
- DP Manufacturing (Drug Product) Fully automated pre-filled syringe (PFS) filling lines and secondary packaging (blister and carton) with serialization and aggregation capabilities for commercial biologic products.
- Analytical Testing Comprehensive physicochemical, microbial, and cell-based testing services including raw materials testing, DS/DP release testing, stability programs, and similarity/comparability testing.
- Quality Management System Quality management system in compliance with global regulatory requirements including FDA, EMA, PMDA, and other international standards, covering batch release and regulatory documentation.
- DMB-3115 (Stelara biosimilar) Biosimilar of Stelara (ustekinumab) for autoimmune diseases, jointly developed with Dong-A ST and Meiji Seika Pharma, manufactured by STgen Bio for global commercial supply.
- DA-3880 (Aranesp biosimilar) Biosimilar of Aranesp (darbepoetin alfa) developed by Dong-A ST for anemia treatment, supplied to Japan through distribution partner SKK.
- ALT-L9 (Eylea biosimilar) Biosimilar of Eylea (aflibercept) manufactured and supplied for Alteogen for age-related macular degeneration treatment.
Companies that use STgen Bio
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles3 records
STgen Bio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
STgen Bio partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered minor and core.
- Yonsei University K-NIBRTminorMOU for specialized workforce training and education. Partnership focuses on developing customized training programs for platform manufacturing technologies and building degree programs for the bio healthcare industry.
- Intas PharmaceuticalscoreGlobal license-out partnership for DMB-3115 biosimilar. Intas obtained rights to commercialize DMB-3115 in global markets, accelerating STgen Bio's entry into US and European pharmaceutical markets through established distribution networks.
- Protium SciencecoreMOU for CDMO business cooperation. Protium Science provides CDO (Contract Development Organization) services as a subsidiary of TiumBio, while STgen Bio provides CMO capabilities. The partnership aims to provide integrated one-stop CDMO services from R&D to production for bioventure companies.
- Dong-A Socio HoldingscoreDong-A Socio Holdings acquired STgen Bio as a subsidiary, unifying the governance structure under single ownership. This enables swift decision-making and focused investment for the company's mid-to-long-term growth strategies. The parent company provides strategic direction and capital support for facility expansion including the 1,100 billion KRW investment.
- Meiji Seika PharmacoreOriginal joint venture partner that established DM Bio (now STgen Bio) with Dong-A Socio Holdings in 2015. Dong-A acquired Meiji's stake in 2021, but partnership continues for DMB-3115 joint development. Meiji brings Japanese market expertise and continues collaboration on biosimilar development.
- SKK (Sankyo Kagaku)minorJapanese distribution partner for DA-3880 (Darbepoetin alfa biosimilar). SKK handles local sales and distribution in Japan following PMDA approval and market launch in 2019.
Scale indicators8 records
Recent moves10 records
Expansion highlights5 records
STgen Bio competitors and assessment
Company assessmentDirect peers
- Celltrion: Korean biosimilar developer and manufacturer that also operates CMO services. Directly comparable in biosimilar mAb manufacturing, mammalian cell culture, and global regulatory approvals (FDA/EMA), with a similar customer base of global pharmaceutical partners.
- WuXi Biologics: Global biologics CDMO with end-to-end DS and DP services and global regulatory approvals. Closely comparable in integrated CDMO services, pre-filled syringe capabilities, and biosimilar client base, though part of a much larger globally diversified operation.
- AGC Biologics: Global mammalian cell culture CDMO with comparable scale (mid-size bioreactors) and end-to-end biologics services. Closely comparable in mid-tier CDMO positioning, regulatory posture, and biosimilar/biosimilar-adjacent client base.
Broad incumbents
- Catalent: Global CDMO with biologics and drug product capabilities including pre-filled syringe filling. Comparable in DP manufacturing and regulatory expertise, but operates across many dosage forms and geographies beyond biologics.
- Samsung Biologics: Korea's largest CDMO with 364,000L+ mammalian cell culture capacity. Comparable as a Korean biopharmaceutical CDMO targeting global pharma clients with FDA/EMA cGMP-certified facilities, but far larger and broader in scope (also offering biosimilars development).
- Fujifilm Diosynth Biotechnologies: Global CDMO with mammalian cell culture and drug product capabilities. Comparable in biologics CDMO services and integrated offerings, but part of a larger global conglomerate with much broader capacity.
- Lonza Group: Global leader in biologics CDMO with multi-modality capabilities (mammalian, microbial, cell therapy). Comparable as a large-scale mammalian cell culture CDMO with FDA/EMA approvals, but with significantly greater scale and global multi-site footprint.
Others
- Alteogen: Korean biosimilar developer and STgen Bio's customer for ALT-L9 (Eylea biosimilar). Comparable as a Korean biosimilar developer with FDA/EMA filings, but operates as a customer rather than a competing CDMO and is a meaningful revenue source for STgen Bio.
Emerging players
- Prestige Biologics: Korean mid-size CDMO with mammalian cell culture manufacturing and biosimilar client base. Closely comparable in scale and Korean CDMO positioning, also serving biosimilar developers with similar drug substance and drug product offerings.
Regional players
- SK Bioscience: Korean biopharmaceutical manufacturer with both vaccines and biologics capabilities. Comparable as a Korean CDMO adjacent to the Dong-A Socio Group ecosystem, but more focused on vaccines and tends to operate in rather than license out.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
STgen Bio social profiles
Digital presenceSTgen Bio compliance and trust
Trust signalCompliance7 records
STgen Bio financial estimates
Financial estimateRevenue estimate
Valuation estimate
STgen Bio leadership team
Management profileNumber of profiles
Profiles1 record
STgen Bio funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
STgen Bio 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 STgen Bio
What does STgen Bio do?
STgen Bio (BTGEN) is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) providing integrated one-stop services from Drug Substance (DS) to Drug Product (DP). The company manufactures antibody-based biopharmaceuticals and recombinant proteins using mammalian cell culture with up to 2,500L bioreactors in a hybrid single-use/multi-use platform, performs fully automated pre-filled syringe filling, and provides analytical testing, regulatory support, and cold chain logistics for global pharmaceutical and biosimilar developers.
Is STgen Bio a public or private company?
STgen Bio is a private company. It is classified as corporate owned and is currently operating.
When was STgen Bio founded?
STgen Bio was founded in 2015. It employs 51 to 100 people.
Where is STgen Bio based?
STgen Bio is headquartered in Incheon, South Korea, in the Asia region.
How does STgen Bio make money?
Three revenue lines are on record. Contract Manufacturing (CMO) is the primary driver. The others are CDMO Services and commercial Manufacturing Supply.
Who are STgen Bio's main competitors?
Direct peers on record are Celltrion, WuXi Biologics and AGC Biologics. Broad incumbents are Catalent, Samsung Biologics, Fujifilm Diosynth Biotechnologies and Lonza Group. Alteogen is listed as an others. Prestige Biologics is listed as an emerging player. SK Bioscience is listed as a regional player.
Does STgen Bio have an API?
No public API is recorded for STgen Bio.
What industry is STgen Bio in?
STgen Bio's product category is Biopharmaceutical Contract Manufacturing (CDMO). Its primary akta.pro industry code is HLAGABAC, Biologics (mAbs/Recombinant Proteins) CDMO, with a secondary code of HLAGABAG, Drug Substance–Drug Product Integrated CDMO. Its NAICS code is 325414 and its SIC code is 2834.