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China · US · EU · UK · Switzerland · Brazil
Bio-Thera
Bio-Thera Solutions, Ltd.
About Bio-Thera
Company Overview
Innovation for Life
Guided by discoveries in modern bioscience, we develop next-generation innovative medicines and biosimilars for cancer, autoimmune, cardiovascular, ophthalmic and other serious diseases.
Putting Patients First
Patients’ well-being is our foremost value. Through innovative research, we strive to provide safe, effective and affordable medicines that address unmet treatment needs.
Listed on the STAR Market 2020 Stock Code 688177
Scale & Global Reach
From Guangzhou to Global Markets
Bio-Thera develops innovative medicines and biosimilars, with multiple products approved across China, the United States, the European Union, the United Kingdom, Switzerland and Brazil. Manufacturing capacity continues to expand in support of domestic and overseas markets.
04areas
Core Therapeutic Areas
Oncology · Autoimmune · Cardiovascular · Ophthalmic
66,500L
Operational Capacity
Antibody Industrial Park · Yonghe, Guangzhou
72,000L
Planned Additional Capacity
Yonghe Innovation Industrial Base
Intellectual property
As of July 2024
- Invention patent filings
- 301
- Core patents granted
- 63
- Applications pending
- 238
Granted patents by jurisdiction
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36Chinese mainland
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10United States
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8Hong Kong, China
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7Macao, China
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1Luxembourg
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1Australia
Explore the portfolio scope
Bio-Thera is building a broad intellectual property system, with 301 invention patent applications filed in China and abroad. The portfolio covers monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), engineered cells and strains, vaccines, compounds and their synthesis and manufacturing processes, therapeutic methods, analytical methods, pharmaceutical compositions, formulations and their preparation, culture media, dissociation solutions, fermentation processes, and recombinant proteins.
Read the Full Company Profile
Who We Are
Bio-Thera is a science-driven, innovative global biopharmaceutical company based in Guangzhou, China. Guided by “Innovation for Life” and discoveries in modern bioscience, we develop next-generation innovative medicines and biosimilars for cancer, autoimmune, cardiovascular, ophthalmic and other serious diseases.
The company was listed on the Shanghai Stock Exchange STAR Market in February 2020 under stock code 688177. Patients’ well-being is our foremost value.
Through innovative research, we strive to provide safe, effective and affordable medicines that address unmet treatment needs.
Global Product Portfolio
As a leader in global antibody drug development, Bio-Thera has advanced multiple medicines to approval. Beitaning® (bevifibatide citrate) is approved in China.
Adalimumab (UK brand: Qletli®; Chinese brand: Geleli®) is approved in China and the United Kingdom. Tocilizumab (US brand: TOFIDENCE®; Chinese brand: Shiruili®) is approved in China, the United States, the European Union, Switzerland and the United Kingdom.
Bevacizumab (US and EU brand: Avzivi®; Chinese brand: Pubeixi®; Brazilian brand: Bevyx®) is approved in China, the United States, the European Union and Brazil. Ustekinumab (US brand: STARJEMZA®; European brand: Usymro®; Chinese brands: Aishali® and Xishali) is approved in China, the United States, the European Union and the United Kingdom.
TOFIDENCE® became the first monoclonal antibody developed and manufactured by a Chinese pharmaceutical company to receive US FDA marketing approval. Several additional candidates are in late-stage clinical trials.
In oncology, the company focuses on immunotherapies for the post-PD-1 era and targeted antibody–drug conjugates (ADCs). Bio-Thera puts patients’ well-being first, pursuing innovative research to provide safe, effective and affordable medicines for unmet treatment needs.
Research & Leadership
Our management team brings extensive experience in drug discovery, manufacturing and commercialization. Under its scientific and technical leadership, Bio-Thera has overcome key technical challenges and built a broad pipeline in oncology, autoimmune, cardiovascular and ophthalmic diseases.
Our manufacturing base meets the quality management system standards of China’s NMPA, the US FDA, the European EMA and Brazil’s ANVISA. Our highly qualified, multidisciplinary team includes experts with international backgrounds and extensive experience in drug development and pharmaceutical management.
Core technical team members have been recognized by the National Major Talent Program, Guangdong’s first group of Leading Science and Technology Talent, Guangzhou’s Leading Innovation and Entrepreneurship Talent, Guangzhou Outstanding Experts, Guangzhou Development Zone Leading Science and Technology Talent, Huangpu District Outstanding Talent, Guangdong’s Pearl River Talent Program for Leading Innovation and Entrepreneurship Teams, Huangpu District Elite Talent, and Guangzhou’s Industrial Development and Innovation Talent Program for urgently needed specialists.
Manufacturing & Expansion
The company’s Antibody Industrial Park in Yonghe Development Zone, Guangzhou, covers approximately 40,000 square meters. Total completed and operational capacity is 66,500 L: six 6,000 L stainless-steel bioreactors with two downstream purification lines; four 4,000 L and two 3,500 L stainless-steel bioreactors; and three 2,000 L and three 500 L single-use bioreactors, each group with associated downstream purification lines.
Additional facilities include a 200 L ADC conjugation reactor with an isolator system and purification line; an integrated vial washing, drying, filling and sealing line for sterile injections; a prefilled syringe filling line; a lyophilized formulation line; a high-speed prefilled syringe line with an intelligent isolator; and a high-speed vial line. Construction of the Yonghe Innovation Industrial Base is accelerating, with 72,000 L of additional monoclonal antibody capacity planned.
On completion, the company’s total capacity will rank among the leading biopharmaceutical manufacturers in China. The base will support innovative medicines and biosimilars planned for launch over the following five years, reinforce manufacturing cost advantages and support expansion in domestic and overseas markets.
INSIDE BIO-THERA
Inside Bio-Thera
Company Film (Mandarin)
MILESTONES
Milestones
2019
Geleli® (the first domestically developed adalimumab injection) approved by the NMPA for marketing
2020Bio-Thera is listed on Shanghai Stock Exchange STAR Market
2023Shiruili® (the first domestically developed tocilizumab injection) approved by China's NMPA and the US FDA
2024Shiruili® and Pubeixi® receive European EMA marketing approval, becoming the first and second domestically developed monoclonal antibodies with dual FDA and EMA approvals, and achieving launches in China, the US, and Europe.
2025
12 Milestones-
September 2025
Bio-Thera and Jamjoom Pharma enter into collaboration on BAT2306 (secukinumab) in the Middle East and North Africa market
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September 2025
Qletli® (adalimumab) receives UK marketing approval from the Medicines and Healthcare products Regulatory Agency
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August 2025
Usymro® (BAT2206) ustekinumab receives marketing approval from European Commission
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August 2025
Bio-Thera and STADA deepen cooperation on BAT1806 in the EU, Switzerland, UK and other countries
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July 2025
Bio-Thera Innovation Center Opens on Bio Island
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June 2025
Bio-Thera and SteinCares deepen collaboration in Brazil and other Latin American regions on fourth investigational biosimilar
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June 2025
Usymro® (BAT2206) ustekinumab receives positive opinion from European CHMP
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May 2025
STARJEMZA® (BAT2206) ustekinumab has been approved by the US FDA
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April 2025
Organon acquires exclusive U.S. commercialization rights to tocilizumab biosimilar TOFIDENCE® intravenous dosage form
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March 2025
Bio-Thera and Dr. Reddy’s Laboratories reach cooperation on BAT2206 and BAT2506 in the Southeast Asian market
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February 2025
Bio-Thera and Intas Pharmaceuticals enter into collaboration on BAT2506 in the US market
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January 2025
Bio-Thera and World Medicine enter into collaboration on BAT2206 in Türkiye
2024
10 Milestones-
December 2024
Bio-Thera and Tabuk Pharmaceutical Manufacturing Company enter into collaboration on BAT2206 in Saudi Arabia
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December 2024
Bio-Thera and SteinCares deepen collaboration in Brazil and other Latin American regions on third investigational biosimilar
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October 2024
Bio-Thera and Gedeon Richter have reached cooperation on BAT2206 in the EU, UK, Switzerland, Australia and other markets
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August 2024
Bio-Thera and Pharmapark deepen cooperation in Russia and other CIS countries on BAT2306
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July 2024
Avzivi® (BAT1706) bevacizumab receives European EMA marketing approval
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June 2024
Beitaning® (bevifibatide citrate injection) (BAT2094), a national Class 1 innovative drug approved for marketing in China
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June 2024
TOFIDENCE (BAT1806) tocilizumab received European EMA marketing approval
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May 2024
Bio-Thera and STADA reach cooperation on BAT2506 in the EU, UK, Switzerland and other European countries
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March 2024
Bio-Thera and STEINCARES reach cooperation on two biosimilars in Brazil and other Latin American regions
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January 2024
Bio-Thera and Macter reach cooperation on BAT1706 in Pakistan and Afghanistan
2023
6 milestones-
December 2023
Avzivi® (BAT1706) bevacizumab receives US FDA marketing approval
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September 2023
TOFIDENCE (BAT1806) tocilizumab received US FDA marketing approval
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June 2023
Bio-Thera and Mega Lifesciences enter into collaboration on BAT1706 in Indonesia
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June 2023
Bio-Thera and Biomm deepen cooperation in Brazil on BAT2206
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February 2023
Bio-Thera and China Resources Pharmaceutical Commercial Group reach strategic cooperation
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January 2023
Shiruili® - the world's first tocilizumab biosimilar approved for marketing
2022
3 milestones-
December 2022
The marketing application for BAT1806/BIIB800 (a biosimilar developed with reference to Actemra® (tocilizumab)) was accepted by the FDA
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September 2022
The marketing authorization application for BAT1806/BIIB800 (a biosimilar developed with reference to Actemra® (tocilizumab)) was accepted by the European Medicines Agency
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April 2022
Pubeixi® approved for three new indications: epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, cervical cancer and recurrent glioblastoma
2021
6 milestones-
November 2021
Pubeixi (bevacizumab injection) has been approved by the NMPA for marketing
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October 2021
Bio-Thera and Pharmapark enter into collaboration on BAT2206 in Russia and other CIS countries
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September 2021
Bio-Thera and Intract Collaborate on Soteria® and Phloral® Drug Delivery Technologies to Develop Oral Antibody Drugs
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September 2021
Bio-Thera and Sandoz have reached a cooperation agreement on BAT1706 in the United States, Europe, Canada and most other international markets not covered by BAT1706 cooperation.
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August 2021
Bio-Thera and Hikma Reach Collaboration on BAT2206 in the U.S. Market
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April 2021
Bio-Thera and Biogen have reached cooperation on BAT1806 in all countries around the world except China (including Hong Kong, Macau and Taiwan)
2020
5 milestones-
December 2020
Bio-Thera and Biomm enter into collaboration on BAT1706 in Brazil
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August 2020
Bio-Thera and BeiGene reach cooperation on BAT1706 in China
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July 2020
Bio-Thera and Pharmapark enter into collaboration on BAT2506 in Russia and other CIS countries
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February 2020
Bio-Thera is listed on Shanghai Stock Exchange STAR Market
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January 2020
Geleli launches commercial sales
2019
4 milestones-
November 2019
Monoclonal antibody production line obtained China GMP certification
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November 2019
Geleli® (adalimumab injection) has been approved by the NMPA for marketing
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March 2019
Company name changed to Bio-Thera Solutions, Ltd.
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January 2019
Bio-Thera and Cipla enter into collaboration on BAT1706 in emerging countries
2018
1 milestone-
June 2018
Groundbreaking for the Bio Island R&D and Marketing Headquarters
2017
2 milestones-
September 2017
Obtained the drug production license for the small-volume injection workshop of the Guangdong Provincial Food and Drug Administration
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August 2017
Antibody Industrial Park successfully passed the EU QP audit
2016
3 milestones-
October 2016
"Recombinant humanized anti-HER2 monoclonal antibody-maytansine conjugate for injection" (BAT8001) received domestic clinical trial approval
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July 2016
Submit clinical trial application for "Recombinant Humanized Anti-IL-6 Receptor Monoclonal Antibody Injection"
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January 2016
"Recombinant humanized anti-VEGF monoclonal antibody injection" BAT1706 received clinical trial approval
2015
2 milestones-
December 2015
"Recombinant human anti-TNF-α monoclonal antibody injection" BAT1406 received clinical trial approval
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May 2015
Submitted a clinical trial application for the innovative antibody drug conjugate "recombinant humanized anti-HER2 monoclonal antibody-maytansine conjugate for injection" (BAT8001), which was recommended by the National Health and Family Planning Commission as an accelerated review product
2014
3 milestones-
October 2014
Awarded "Guangdong Province Postdoctoral Innovation Practice Base" by the Guangdong Provincial Department of Human Resources and Social Security
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January 2014
Won the Guangdong Province "Pearl River Talent Plan" to introduce innovative and entrepreneurial teams
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January 2014
Submit clinical trial application for "Recombinant Humanized Anti-VEGF Monoclonal Antibody Injection" (BAT1706) to the National CFDA
2013
1 milestone-
March 2013
Submit clinical trial application for "Recombinant Human Anti-TNF-α Monoclonal Antibody Injection" (BAT1406) to the National CFDA
2012
1 milestone-
July 2012
Awarded "Guangzhou Postdoctoral Innovation Practice Base" by the Guangzhou Municipal Human Resources and Social Security Bureau
2011
1 milestone-
November 2011
The National Ministry of Science and Technology awarded the "Human Antibody Innovative Drug Incubation Base" to undertake major national scientific and technological projects for new drug creation.
2010
1 milestone-
October 2010
Dr. Shengfeng Li was selected into the first batch of leading scientific and technological talents in Guangdong Province and leading talents in Guangzhou (Hundred Talents Plan)
2009
2 milestones-
October 2009
Company CEO Dr. Shengfeng Li was selected into the National Major Talent Project
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March 2009
Named the "Most Potential Company" by Hong Kong ChinaBio Biotechnology Venture Capital Forum
2003
1 milestone-
July 2003
Bio-Thera Biotechnology (Guangzhou) Co., Ltd. was officially established
Innovation for Life
- Our Mission
- Committed to developing a new generation of innovative drugs and biosimilars for the treatment of tumors, autoimmune diseases, cardiovascular diseases, ophthalmology and other major diseases that threaten human life or health
- Our Vision
- Become a leader in new generation antibody drug technology and product development in China and even the world
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Life First
Patient well-being is the company's primary core value. We strive to innovate in research and development to provide patients with safe, effective, affordable and high-quality drugs to meet urgent treatment needs.
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Empower Our Team
All employees are the company's most valuable asset. We fairly recognize and actively reward employees who have made contributions.
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Keep Our Promises
Adhere to principles, uphold beliefs, value cooperation, and maintain trust. We promise to be completely trustworthy and transparent to society, customers, partners, and employees at all times.
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Uphold Our Responsibilities
Adhere to the highest ethical standards. We must abide by the highest ethical standards in conducting our daily business. The meaning of our existence is to help patients use safe, effective and affordable innovative drugs.
Recognition
Major national, provincial and municipal recognitions and qualifications witness every step of development.
National recognition
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National level
National high-tech enterprise
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National level
National Industrial Enterprise Intellectual Property Utilization Pilot Enterprise
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National level
Bio-Thera Human Antibody Innovative Drug Incubation Base (National 12th Five-Year Plan Major Project)
Provincial recognition
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Provincial level
Guangdong Enterprise Technology Center
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Provincial level
Guangdong Antibody–Drug Conjugate Biomedical Engineering Laboratory (Guangdong Provincial Engineering Laboratory)
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Provincial level
Guangdong Antibody–Drug Conjugate Engineering Technology Research Center (Guangdong Provincial Engineering Technology Research Center)
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Provincial level
Bio-Thera Biotechnology Research Institute (Guangdong Province New R&D Institution)
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Provincial level
Guangdong Province Doctoral Workstation
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Provincial level
Guangdong Province Postdoctoral Innovation Practice Base
City level and industry awards
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city level
Guangzhou Science and Technology Innovation Little Giant Enterprise
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city level
Guangzhou Development Zone Gazelle Enterprise
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city level
Construction of R&D institution of Bio-Thera Biotechnology (Guangzhou) Co., Ltd.
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Industry Awards
“Most Promising Company” Recognition from Hong Kong Venture Capital
Historical recognitions · 2011–2021
Dates and recognitions recorded in the August 2024 corporate brochure, pp. 15–16; historical awards do not indicate current certification validity.
- 2021.12High and New Technology Enterprise
- 2020.122020 Pilot Industrial Enterprise for Intellectual Property Utilization
- 2018.12Guangdong Doctoral Workstation
- 2016–2018Guangdong New R&D Institution
- 2017.11Guangzhou Innovation Benchmark Enterprise
- 2016Guangdong Antibody–Drug Conjugate Engineering Technology Research Center
- 2015Guangzhou Enterprise Research and Development Institution
- 2014.10Guangdong Postdoctoral Innovation Practice Base
- 2014.01Innovation and Entrepreneurship Team under Guangdong’s Pearl River Talent Program
- 2012.07Guangzhou Postdoctoral Innovation Practice Base
- 2011.11Bio-Thera Human Antibody Innovative Drug Incubation Base (National Major Project under the 12th Five-Year Plan)