What Bio-Thera Solutions does

Bio-Thera Solutions (百奥泰生物制药股份有限公司) is a Guangzhou-headquartered, publicly listed (Shanghai STAR Market, ticker 688177) commercial-stage biopharmaceutical company founded in 2003 that develops both biosimilars and innovative antibody drugs for oncology, autoimmune disease, cardiovascular disease, and ophthalmology. Its six proprietary technology platforms span antibody discovery (IDEAL engine, libraries of thousands of unique human antibody clones), AI-driven sequence-structure-function optimization, ADCC enhancement and Fc engineering, bispecific/multispecific dual-payload ADC construction with proprietary cleavable linkers, proprietary cell culture medium development, and full-chain quality research aligned with NMPA, FDA, and EMA standards. The company has 8 commercialized products: 格乐立®/Qletli® (adalimumab), 普贝希®/Avzivi®/Bevyx® (bevacizumab), 施瑞立®/TOFIDENCE® (tocilizumab), 贝塔宁® (bivalirudin, since transferred to Lepu in April 2026), 艾沙力®/喜沙立®/STARJEMZA®/Usymro® (ustekinumab), Gotenfia®/IMMGOLIS™ (golimumab), plus two BLAs under review (BAT4406F for NMOSD and BAT5906 for nAMD). The pipeline also includes multiple ADC candidates (BAT8006 FRα, BAT8008 Trop2, BAT8010 HER2, BAT8013 CD25), bispecific antibodies (BAT7111 PD-1/4-1BB, BAT7205 PD-L1/IL-15, BAT7104 PD-L1/CD47), and additional biosimilars (secukinumab, dupilumab, mepolizumab, pembrolizumab).

The business model is hybrid: Bio-Thera retains development, manufacturing, and supply of all products globally (66,500L current bioreactor capacity with 72,000L expansion planned at Yonghe, 91,744 m² facility), commercializes approved products directly in mainland China, and licenses regional commercialization rights to established pharmaceutical partners across the US (Accord BioPharma/Intas, Organon, Hikma), EU/UK/Switzerland (STADA, Gedeon Richter), MENA (Avalon, Jamjoom), Southeast Asia (Dr. Reddy's), Latin America (SteinCares), Canada (Accord), and India (Intas). Revenue mechanics include upfront fees, regulatory and development milestone payments, royalties on partner net sales (BAT2206 reaches 71+ countries), direct product sales in China, and one-time license transactions for mature assets (the CNY 450M Lepu deal being the most recent example). GMP certifications have been granted by NMPA, FDA, EMA, and ANVISA, supporting multi-region market access.

Name

Bio-Thera Solutions

Legal name

百奥泰生物制药股份有限公司

Website

https://bio-thera.com

Company type

Public

Founded year

2003

Operating status

Operating

Headcount range

251–500 employees

Short description

Bio-Thera Solutions is a Guangzhou-based, publicly listed Chinese biopharmaceutical company developing biosimilars and innovative antibody drugs (including ADCs and bispecifics) for cancer, autoimmune, cardiovascular, and ophthalmic diseases, commercializing via global regional partners.

Ownership category

akta.pro rank

Product category

Biosimilars and Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Monoclonal Antibody (mAb) Biosimilars (HLAAAHAA)

akta.pro secondary industries

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Oncology Biosimilars (HLAAAHAG), Immunology & Inflammation Pharmaceuticals (HLAIAAAD), Other Recombinant Protein Biosimilars (non-mAb, non-hormone) (HLAIAFAL), Automation, Controls & Manufacturing Execution for Bioprocessing (SCADA/DCS/PLC/MES) (HLAAAJAE)

Keywords

• Biosimilar development
• Antibody therapeutics
• Oncology drug development
• Autoimmune disease treatments
• Biopharmaceutical manufacturing

Headquarters

HQ city

Guangzhou

HQ country

China

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D

Revenue model

1. Biosimilar Licensing & Royalty Revenue: Bio-Thera develops and manufactures biosimilars while licensing commercialization rights to regional pharmaceutical partners. Partners pay upfront fees, milestone payments upon regulatory achievements, and ongoing royalties on net sales. For example, STADA deal for Gotenfia worth up to USD157.5 million plus royalties; STADA deal for BAT1806 up to EUR136 million plus double-digit royalties; BAT2506 with Intas/Accord across US, Canada, and India markets.
2. Product Sales (Domestic China): Direct commercialization of approved products in China including 格乐立® (adalimumab), 施瑞立® (tocilizumab), 普贝希® (bevacizumab), 贝塔宁® (bivalirudin), 艾沙力®/喜沙立® (ustekinumab). In April 2026, Bio-Thera transferred rights to 贝塔宁® to Lepu Pharmaceutical for RMB 450 million plus single-digit royalties on net sales for up to 10 years, indicating strategic monetization of mature products.
3. Milestone Payments from Partners: Receipt of milestone payments upon achievement of regulatory and development milestones from commercial partners. Recent announcements confirm receipt of milestone payments from STADA (BAT2506 and BAT1806), Gedeon Richter (BAT2206), Hikma (BAT2206), Sandoz (BAT1706), and Intas (BAT2506).
4. Innovation Drug Development: Development and potential commercialization of proprietary innovative drugs including BAT4406F (CD20, NMOSD filing), BAT5906 (VEGF, nAMD filing), BAT8006 (FRα ADC, Phase III), BAT8008 (Trop2 ADC, Phase I), BAT1308 (PD-1), BAT7111 (PD-1/4-1BB bispecific), and BAT7205 (PD-L1/IL-15). Revenue from innovative drugs will come upon regulatory approvals and product sales.

Go-to-market motion2 records

Distribution channels9 records

Marketing channels6 records

Core offering

Bio-Thera Solutions is a global biopharmaceutical company that develops, manufactures, and commercializes innovative antibody drugs and biosimilars for oncology, autoimmune diseases, cardiovascular diseases, and ophthalmology. The company has 8 commercialized products (adalimumab, bevacizumab, tocilizumab, bivalirudin, ustekinumab, and golimumab biosimilars) approved across China, US, EU, UK, Brazil, Switzerland, and Singapore, plus a pipeline of ADCs, bispecific antibodies, and innovative monoclonal antibodies.

Product overview

Bio-Thera Solutions is a global biopharmaceutical company developing novel drugs and biosimilars for oncology, autoimmune diseases, cardiovascular diseases, and ophthalmology. The company operates a platform of marketed products including 6 approved biosimilars/innovative drugs (adalimumab, bevacizumab, tocilizumab, ustekinumab, golimumab, and betrifbatide) with global reach across China, US, EU, UK, Brazil, Switzerland, and Singapore. The pipeline includes multiple ADC candidates (BAT8006/FRα, BAT8008/Trop2, BAT8010/HER2, BAT8013/CD25), bispecific antibodies (BAT7104/PD-L1-CD47, BAT7111/PD-1-4-1BB, BAT7205/PD-L1-IL-15), innovative mAbs (BAT4406F/CD20, BAT1308/PD-1, BAT4706/CTLA-4), and additional biosimilars (BAT2306/secukinumab, BAT2406/dupilumab, BAT2606/mepolizumab, BAT3306/pembrolizumab). The company has established global commercialization partnerships with STADA (EU), Accord BioPharma/Intas (US, Canada, India), Hikma (US), Gedeon Richter (EU), Dr. Reddy's (Southeast Asia), Jamjoom (MENA), Avalon (MENA), and SteinCares (Latin America).

Differentiator

Problem solved

Functional benefit

Brands

• BAT: Internal development code prefix for pipeline candidates (e.g., BAT2506, BAT2206, BAT1308, BAT8008)

Products and services

• 格乐立®/Qletli® (BAT1406 Adalimumab Biosimilar) TNF-α inhibitor biosimilar referencing Humira® for treating autoimmune diseases including rheumatoid arthritis, psoriasis, ankylosing spondylitis, Crohn's disease, and uveitis. Approved in China and UK (as Qletli®).
• 普贝希®/Avzivi®/Bevyx® (BAT1706 Bevacizumab Biosimilar) VEGF inhibitor biosimilar referencing Avastin® for oncology indications including non-small cell lung cancer, colorectal cancer, glioblastoma, ovarian cancer, and cervical cancer. Approved in China (普贝希®), EU/US (Avzivi®), and Brazil (Bevyx®).
• 施瑞立®/TOFIDENCE® (BAT1806 Tocilizumab Biosimilar) IL-6R inhibitor biosimilar referencing Actemra® for rheumatoid arthritis, juvenile idiopathic arthritis, cytokine release syndrome, and COVID-19. First China-developed mAb approved by FDA. Approved in China (施瑞立®), US (TOFIDENCE®), EU, Switzerland, and UK.
• 贝塔宁® (BAT2094 Bivalirudin / Citric Acid Bivatide) Innovative Category 1 chemical drug, peptide β3 integrin receptor inhibitor for acute coronary syndrome patients undergoing PCI to reduce acute occlusion, stent thrombosis, and no-reflow risks. Approved in China; product rights transferred to Lepu Pharmaceutical in April 2026.
• 艾沙力®/喜沙立®/STARJEMZA®/Usymro® (BAT2206 Ustekinumab Biosimilar) IL-12/IL-23 p40 subunit inhibitor biosimilar referencing Stelara® for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Approved in China (艾沙力®/喜沙立®), US (STARJEMZA®), EU (Usymro®), UK, Brazil, Switzerland, and Singapore.
• Gotenfia®/IMMGOLIS®/IMMGOLIS INTRI® (BAT2506 Golimumab Biosimilar) First FDA-approved golimumab biosimilar referencing Simponi®/Simponi Aria®, TNF-α inhibitor for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis. Approved in EU (Gotenfia®) and US (IMMGOLIS®/IMMGOLIS INTRI®).

Quantifiable outcome

• BAT8008 (Trop2 ADC) in cervical cancer: cORR 29.3%, DCR 75.6%, mPFS 6.7 months, mDoR 9.0 months, mOS 17.8 months at 2.4 mg/kg dose (N=41)
• +5 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Ten partnerships are on record, tiered minor and core.

• Avalon PharmaminorChannel Partner/ Reseller/ Distributor · 1 February 2026In February 2026, Bio-Thera signed a licensing and commercialization agreement with Avalon Pharma for BAT3306 (pembrolizumab biosimilar) covering Saudi Arabia and the wider MENA region. Bio-Thera handles development, manufacturing, and supply while Avalon pursues regulatory approvals and leads commercialization. The partnership aims to expand access to immuno-oncology medicines in the MENA region.
• Dr. Reddy's Laboratories Ltd.minorChannel Partner/ Reseller/ Distributor · 1 November 2025In November 2025, Bio-Thera expanded partnership with Dr. Reddy's for BAT2306 (secukinumab biosimilar) in Southeast Asian markets including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand, and Vietnam. Dr. Reddy's has exclusive distribution and sales rights and handles registration and commercialization. Bio-Thera handles development, manufacturing, and supply.
• Jamjoom Pharma (Jamjoom Pharmaceuticals Factory Company)minorChannel Partner/ Reseller/ Distributor · 1 September 2025In September 2025, Bio-Thera signed a licensing and commercialization agreement with Jamjoom Pharma for BAT2306 (secukinumab biosimilar) covering Middle East and North Africa markets. Jamjoom has exclusive distribution and sales rights and handles registration and market access. Bio-Thera handles development, manufacturing, and supply.
• SteinCares S.A.minorChannel Partner/ Reseller/ Distributor · 1 June 2025In June 2025, Bio-Thera partnered with SteinCares S.A. to commercialize BAT2406 (dupilumab biosimilar) for treating chronic inflammatory diseases throughout Latin America. The partnership combines Bio-Thera's biologics development expertise with SteinCares's regional registration and commercialization capabilities.
• Organon LLCcoreChannel Partner/ Reseller/ Distributor · 1 April 2025In April 2025, Organon acquired US rights to TOFIDENCE® (tocilizumab-bavi) intravenous formulation from Bio-Thera. TOFIDENCE was first approved by US FDA in May 2024. Organon handles US market promotion and sales while Bio-Thera maintains manufacturing and commercial supply. In June 2026, FDA approved expanded indications for TOFIDENCE including CAR T cell-induced CRS and pediatric COVID-19.
• Accord BioPharma (Intas Pharmaceuticals US subsidiary)coreChannel Partner/ Reseller/ Distributor · 1 February 2025In February 2025, Bio-Thera signed an exclusive licensing and commercialization agreement with Intas Pharmaceuticals for BAT2506 (golimumab biosimilar) in the US market. Accord BioPharma (Intas's US subsidiary) commercializes the product in the US. In October 2025, the partnership expanded to include Canada. In March 2026, it further expanded to India. Bio-Thera handles development, manufacturing, and supply while Accord handles commercialization. Under the 2026 expansion, Intas has exclusive commercialization rights in US, Canada, and India.
• Gedeon Richter Plc. (吉瑞医药)minorChannel Partner/ Reseller/ Distributor · 1 October 2024In October 2024, Bio-Thera partnered with Gedeon Richter for BAT2206 (ustekinumab biosimilar) commercialization in EU, UK, Switzerland, Australia, and other European countries. Bio-Thera handles development, manufacturing, and supply while Gedeon Richter handles commercialization. Usymro® received EU approval in August 2025 and UK MHRA approval in February 2026.
• STADA Arzneimittel AGcoreChannel Partner/ Reseller/ Distributor · 1 May 2024In May 2024, Bio-Thera partnered with STADA for Gotenfia® (BAT2506, golimumab biosimilar) commercialization in EU, UK, Switzerland and other European countries. Deal worth up to USD 157.5 million plus royalties. In August 2025, partnership expanded to include BAT1806 (tocilizumab biosimilar) for EU, Switzerland, UK, other European countries, and selected MENA and CIS countries with up to EUR 136 million plus double-digit royalties. Bio-Thera handles development and manufacturing; STADA handles commercialization.
• Hikma Pharmaceuticals USA Inc.coreChannel Partner/ Reseller/ Distributor · 1 August 2021In August 2021, Bio-Thera signed an exclusive US commercialization agreement with Hikma for STARJEMZA® (BAT2206, ustekinumab biosimilar). Bio-Thera handles development, manufacturing, and supply while Hikma has exclusive US commercialization rights. Product launched in the US in November 2025 with milestone payments received by Bio-Thera.
• Janssen Biotech / Janssen Sciences Ireland UCminorOthersAdversarial relationship: Janssen Biotech filed a BPCIA patent infringement complaint in March 2026 in the US District Court for the District of Delaware against Bio-Thera Solutions and Accord BioPharma, alleging infringement of 17 patents related to their golimumab biosimilar BAT2506/IMMGOLIS. Separately, in March 2026, Accord, Intas, and Bio-Thera filed four IPR petitions challenging Janssen's Simponi patents. The dispute is ongoing.

Scale indicators5 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Henlius: Shanghai-based biopharmaceutical company developing and commercializing biosimilars (adalimumab, bevacizumab, trastuzumab, rituximab) and oncology innovation drugs with global regulatory approvals. Closest China-headquartered biosimilar peer with overlapping mAb pipeline and established partnerships.
• Innovent Biologics: China-listed biotech developing monoclonal antibody biosimilars and innovative oncology biologics including PD-1 inhibitors and bispecifics. Directly comparable in combining a biosimilar base with a proprietary innovation pipeline targeting similar indications.
• Shanghai Junshi Biosciences: Shanghai-listed Chinese biopharma with both biosimilar and innovative antibody programs across oncology and autoimmune disease. Comparable in mAb development depth, Chinese listing, and global regulatory strategy.
• Celltrion: South Korea-based biosimilar leader with FDA/EMA-approved infliximab (Inflectra), rituximab (Truxima), trastuzumab (Herzuma), and other mAb biosimilars. Closest non-Chinese direct peer in mAb biosimilars with global commercial partnerships.
• Samsung Bioepis: Joint venture between Samsung Biologics and Biogen developing and commercializing biosimilars including adalimumab, etanercept, infliximab, ranibizumab, trastuzumab. Highly comparable in mAb biosimilar pipeline and global commercialization partnerships.
• Alvotech: Iceland-based pure-play biosimilar developer focused on mAb biosimilars (adalimumab, ustekinumab, aflibercept) with FDA/EMA approvals and global partner network. Comparable in narrow portfolio of mAb biosimilars plus manufacturing scale at Reykjavik hub.
• Biocon Biologics: India-based subsidiary of Biocon Limited developing monoclonal antibody biosimilars (trastuzumab, bevacizumab, adalimumab, etanercept) with FDA/EMA approvals and global commercial partnerships. Comparable emerging-market biosimilar developer with similar international partner strategy.

Broad incumbents

• Shanghai Pharmaceuticals Holding: Large state-linked Chinese pharmaceutical group with broad generics, APIs, and biopharmaceutical operations including biosimilars. Comparable as a China-headquartered broader pharmaceutical player whose biologicals segment overlaps with Bio-Thera.
• BeiGene: Global oncology-focused biotech with PD-1 inhibitor (tislelizumab) and broad hematology portfolio approved in U.S. and China. Comparable as a China-headquartered biopharma with innovative antibody drugs and global commercial footprint, though focused on innovation rather than biosimilars.

Others

• WuXi Biologics: China-based biologics contract development and manufacturing organization with large-scale bioreactor capacity and biosimilar/innovator co-development. Comparable as a China-headquartered biologics manufacturer; a potential CDMO partner or competitor for Bio-Thera's manufacturing footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/bio_thera_sol
• LinkedInlinkedin.com/company/bio-thera-solutions-ltd

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries8 records

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 Bio-Thera Solutions