Genovior Biotech Corp

What Genovior Biotech Corp does

Genovior Biotech Corp (麗揚生技製藥股份有限公司) is a Taiwan-based, vertically integrated pharmaceutical contract development and manufacturing organization (CDMO) founded in 2015 by Dr. Steve Hsu and headquartered in Zhunan Township, Miaoli County, with a second manufacturing site in Tainan. The company provides one-stop services spanning process development, scale-up, formulation development, analytical method development, and commercial manufacturing of peptide and protein biologics, small molecules, sterile injectables (vials, pre-filled syringes, cartridge pens), and high-potency oncology APIs. Its core technology platform is described as one of Asia's few fully synthetic peptide drug development capabilities (combining solid- and liquid-phase synthesis with multiple chemical modifications) integrated with PEGylation, microsphere, nanoparticle, micellar, and liposome long-acting release delivery systems, plus dedicated HPAPI/cytotoxic containment facilities.

Genovior operates under PIC/S GMP and holds multi-jurisdiction regulatory certifications from TFDA, EU GMP (QPD), US FDA, Japan PMDA (AFM), Swissmedic, and Philippines FDA across both API and injectable product lines, with 20 drug certificates obtained within six years of founding and a Zhunan oncology aseptic lyophilized injectable plant approved by Swissmedic in 2023. The Tainan facility targets 10 million units per year of sterile injectable commercial capacity. Revenue is generated through three streams: contract development and manufacturing service fees, drug licensing and royalty income (including exclusive regional licensing deals with a German multinational for psychiatric drugs in the Middle East and a US pharmaceutical company for fully synthetic peptides), and proprietary API sales. Customers include global pharmaceutical companies, oncology drug developers, peptide drug developers, and sterile injectable product companies, served through direct B2B sales and major industry trade shows (CPHI Japan/China/SEA/Frankfurt, INTERPHEX Tokyo, BIO Asia-Taiwan). Since January 2024, Genovior has operated as a key subsidiary of Polaris Group (北極星藥業集團, TWSE:6550), a Taiwan-listed biopharmaceutical company, with Dr. Hsu serving as Chairman of both entities.

Name

Genovior Biotech Corp

Legal name

Genovior Biotech Corporation

Website

https://genovior.com.tw

Company type

Private

Founded year

2015

Operating status

Operating

Short description

Genovior Biotech Corp is a Taiwan-based, vertically integrated pharmaceutical CDMO providing one-stop process development, formulation, and commercial manufacturing of synthetic peptides, biologics APIs, and sterile injectables, serving global pharma clients under multi-jurisdiction GMP certifications as a subsidiary of Polaris Group (TWSE:6550).

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Development and Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industries

Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB), Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI), Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), GMP Quality, Validation & Regulatory Support (GMP/CSV/Qualification) (HLAGAGAL)

Keywords

• Contract pharmaceutical manufacturing
• Sterile injectable manufacturing
• Peptide drug development
• Biologics contract manufacturing
• Oncology API manufacturing

Headquarters

HQ city

Miaoli

HQ country

Taiwan

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales, Supply Chain

Revenue model

1. Contract Development and Manufacturing (CDMO/CMO): Genovior provides end-to-end CDMO services including process development, scale-up, formulation development, and manufacturing of peptide/protein biologics and sterile injectable dosage forms. Revenue is generated through service contracts for preclinical, clinical, and commercial manufacturing, with payment structures including upfront payments, milestone payments, and ongoing manufacturing fees.
2. Drug Licensing and Royalty Income: Revenue generated from exclusive licensing agreements for proprietary drug formulations in specific markets. Under the European licensing agreement, Genovior receives royalties and milestone payments. The US licensing agreement includes upfront payments, milestone payments, and double-digit tiered royalties.
3. Active Pharmaceutical Ingredient (API) Sales: Manufacturing and sale of proprietary peptide and small molecule APIs to pharmaceutical customers for use in their drug products

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Genovior Biotech Corp is a vertically integrated pharmaceutical CDMO providing one-stop services under PIC/S GMP (cGMP, EU GMP), including process development, scale-up, formulation development, and manufacturing of peptide/protein biologics and sterile injectable dosage forms (lyophilized vials, pre-filled syringes, cartridge pens, cartridge pre-filled pens) for preclinical, clinical, and commercial use. The company also provides dedicated cytotoxic/HPAPI oncology manufacturing, analytical method development, monoclonal antibody services, and regulatory registration support, with operations in Zhunan and Tainan, Taiwan, serving global pharmaceutical clients.

Product overview

Genovior Biotech Corp is a vertically integrated pharmaceutical CDMO (Contract Development and Manufacturing Organization) providing one-stop services from process development to commercial manufacturing. The company operates under PIC/S GMP (cGMP, EU GMP) standards and offers: (1) Peptide and small molecule API synthesis services, (2) Protein/biologics process development, (3) Formulation development including long-acting release delivery systems, (4) Analytical method development and validation, (5) Monoclonal antibody development, (6) Small-scale injection and biologic API manufacturing, (7) Dedicated oncology drug manufacturing, and (8) Regulatory affairs services. The company operates manufacturing facilities in Zhunan and Tainan, Taiwan, serving pharmaceutical clients worldwide.

Differentiator

Problem solved

Functional benefit

Products and services

• Synthesis Services (Peptide APIs and Small Molecule Drugs) Professional peptide API and small molecule drug synthesis services including process development, scale-up, and small-scale production for clinical trials and regulatory filing, combining solid phase and liquid phase synthesis with a wide range of chemical modifications. Serves pharmaceutical customers developing peptide and small molecule therapeutics.
• Protein Process Development Development of protein processes for new or generic biologics, including upstream (microbial or human recombinant fermentation) and downstream (purification) process development from shake flask through commercial scale. Serves pharmaceutical and biotech customers developing biologics.
• Formulation Development Full CMC formulation development for small molecules, peptides, and proteins, covering liquid solutions, suspensions, liposomes, lyophilized products, and long-acting release delivery systems including PEGylation, microspheres, and nanoparticles.
• Analytical Development Analytical method development, qualification, and validation services for protein and peptide APIs and drugs, including stability testing following ICH, US-FDA, and EMA guidelines.
• Monoclonal Antibody Development Services One-stop biologics services for monoclonal antibodies including gene design, process development, product analysis, and cGMP-compliant production from preclinical to commercial scale.
• Sterile Injectable Manufacturing (Liquid and Lyophilized Vials, Pre-filled Syringes, Cartridges, Dual-Chamber PFS) Small- and commercial-scale aseptic manufacturing of liquid and lyophilized vials, pre-filled syringes (single and dual chamber), and cartridge pens for clinical and commercial supply under PIC/S GMP. Tainan facility expected capacity of 10 million units per year.
• Biologic API Manufacturing (Mammalian Cell Systems) Clinical and commercial-scale biologic manufacturing services using mammalian cell systems with upstream fermentation, downstream purification, and lyophilization capabilities.
• Oncology (Cytotoxic / HPAPI) Drug Manufacturing Dedicated sterile production lines for cytotoxic and high-potency oncology drugs including lyophilized and liquid injectables for clinical and commercial scale manufacturing, with dedicated containment to prevent cross-contamination (e.g., Bortezomib, Pemetrexed, Azacitidine, Fulvestrant APIs and injectables).
• Regulatory Affairs Services Regulatory registration services including CTD preparation, domestic and international drug registration for APIs, generic injectables, and biosimilars to support global filings.

Quantifiable outcome

• 20 drug certificates obtained within 6 years
• +3 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Eleven partnerships are on record, tiered core and minor.

• MNR Therapeutics (Switzerland)coreChannel Partner/ Reseller/ Distributor · 21 November 2025Non-exclusive agreement for distribution and commercialization of Fulvestrant in GCC countries for treatment of HR+/HER2-negative advanced breast cancer. Covers registration, supply, and market access activities across the Gulf Cooperation Council region.
• US Pharmaceutical CompanycoreGTM or Marketing Partner · 24 July 2025Exclusive product licensing and collaboration agreement for fully synthetic peptide pharmaceuticals in the US market. Genovior will receive upfront payments, milestone payments, and double-digit tiered royalties. The licensed portfolio generated $650 million in US sales in 2022 with 5% CAGR.
• European International Company (Germany)coreGTM or Marketing Partner · 22 July 2025Genovior signed an exclusive licensing and commercialization agreement granting development, registration, and commercialization rights for psychiatric medications in Saudi Arabia and multiple Middle East markets. The European partner focuses on consumer healthcare, generic drugs, and specialty pharmaceuticals with €4 billion in annual sales and distribution in over 100 countries.
• Immunwork (Taiwan)minorStrategic or Co-development Partner · 27 July 2022Collaboration for development and CDMO manufacturing of short-chain peptide drug candidates. Genovior provides injection formulation development and subsequent contract manufacturing services.
• European Pharmaceutical CompaniescoreGTM or Marketing Partner · 8 June 2022Exclusive licensing agreements for specialty oncology lyophilized injectable generic drugs in European markets. Genovior will exclusively supply injection drugs to customers with sales revenue sharing. Commercialization expected to begin 2023-2024.
• Sinphar Group (杏輝醫藥集團, 1734, Taiwan)coreStrategic or Co-development Partner · 6 November 2021MOU for strategic partnership to jointly develop high-tech cytotoxic drug APIs and sterile injectables. Both companies are among the few in Taiwan with cytotoxic sterile injectable manufacturing capabilities, aiming to share R&D and production capacity resources.
• Alar Pharm/昱展新藥 (Taiwan, 6785)coreStrategic or Co-development Partner · 3 November 2021Strategic partnership for long-acting injection drug development targeting CNS disorders and chronic diseases including opioid addiction and treatment-resistant depression. Genovior provides clinical drug production with focus on high-quality, cost-competitive products.
• Cellivery (Korea)minorStrategic or Co-development Partner · 15 October 2018Partnership for protein new drug development collaboration, manufacturing non-GMP-level iCP-Parkin for further R&D work.
• JOWIN Biopharma (Taiwan)minorStrategic or Co-development Partner · 14 September 2018MOU for targeted cancer drugs and immunotherapy drugs development. Genovior provides peptide synthesis, API synthesis, peptide-drug fusion technology, and injectable manufacturing capabilities.
• Clinipace, Inc. (USA)minorStrategic or Co-development Partner · 14 August 2017MOU to forge strategic alliance providing global clients with efficient one-stop solution from CRO to CDMO, from clinical trials to commercial production.
• Velit Biopharmaceuticals GmbH (Austria)minorStrategic or Co-development Partner · 30 August 2016Letter of Intent for development of Ranibizumab biosimilar. Genovior to purchase biologically active ingredients from Velit and manufacture finished products in pre-filled syringes.

Scale indicators8 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Catalent (Novo Holdings): US-headquartered global CDMO providing softgel, biologics, and sterile injectable fill/finish. Overlaps with Genovior's sterile injectable, pre-filled syringe, and cartridge pen capabilities, though larger and broader in scope.
• Lonza Group: Swiss global CDMO leader offering biologics, small molecules, and cell-and-gene services. Comparable on peptide API and sterile injectable manufacturing, with multi-country GMP and HPAPI capabilities overlapping Genovior's core platform.
• Bachem: Swiss-headquartered CDMO specializing in peptide and oligonucleotide APIs and complex injectables. Directly comparable to Genovior on synthetic peptide capabilities and sterile injectable fill/finish, though considerably larger and more established globally.
• Samsung Biologics: Korean biologics CDMO offering mammalian-cell contract manufacturing at large scale. Direct peer for Genovior's protein/biologics fermentation and downstream work as well as Asia-based CDMO competition.
• Aenova Group: German CDMO focused on oral solids, sterile liquids, and semi-solids with a strong European pharma customer base. Comparable to Genovior's sterile injectable and small-molecule injectable manufacturing work.
• Recipharm: Swedish CDMO with sterile injectable fill/finish and API capabilities across multiple dosage forms. Comparable to Genovior on sterile injectables and European multi-market GMP coverage for global partners.
• CordenPharma: European CDMO with strong peptide, lipid, and sterile injectable manufacturing capabilities. Comparable to Genovior's synthetic peptide and HPAPI/sterile injectable business, especially for Western pharma customers.
• Piramal Pharma Solutions: India-headquartered CDMO providing API, peptide, and sterile injectable services. Direct competitor in peptide CDMO and Asia-region CDMO capacity serving global pharma customers.
• WuXi STA (WuXi AppTec): Chinese CDMO arm of WuXi AppTec providing API, peptide, and sterile injectable services under global GMP standards. Direct competitor in Asia-based CDMO services spanning peptides, HPAPI, and injectables.

Emerging players

• ChemPartner: China-based CRO/CDMO with peptide synthesis, biologics, and small-molecule services for global pharma. Adjacent competitor primarily in Asia serving similar early-to-mid-stage biotech CDMO demand as Genovior.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/genovior-biotech-corporation

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Genovior Biotech Corp