Company News Archive
All 104 company news releases previously published on the Bio-Thera website, kept on this site.
2026
- Bio-Thera Announces Promising Clinical Data for BAT8008 in Combination with BAT1308 in First-Line Non-Small Cell Lung Cancer at ESMO 2026
- Avalon Pharma and Bio-Thera Execute Exclusive Commercialization Agreement for BAT2406, a Proposed Dupixent® Biosimilar, for MENA
- Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8013, an Antibody Drug Conjugate Targeting CD25 for the Treatment of Advanced Solid Tumors
- Bio-Thera Solutions’ Golimumab Biosimilars Receive FDA Approval as First Biosimilars to Simponi® and Simponi Aria®; Accord BioPharma to Commercialize IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) in the United States
- Bio-Thera Solutions Announces Further Expansion of Partnership with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), through Exclusive Commercialization and License Agreement in India
- Bio-Thera Solutions Announces NMPA Accepts New Drug Application for BAT4406F, an ADCC-enhanced fully humanized anti-CD20 monoclonal antibody
- STADA and Bio-Thera receive European Marketing Authorization for Gotenfia, a Biosimilar to Simponi
- Bio-Thera and Avalon Pharma Execute Exclusive Commercialization Agreement for BAT3306, a Proposed Keytruda® Biosimilar for Saudi Arabia and MENA
2025
- Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion
- Bio-Thera Solutions Expands Partnership with Dr. Reddy’s through an Exclusive Commercialization and License Agreement for BAT2306, a Proposed Biosimilar Candidate to Cosentyx® (Secukinumab), in Southeast Asia
- Bio-Thera Solutions Announces the Launch of STARJEMZA® (ustekinumab-hmny) in the United States
- Bio-Thera Solutions Announces Expansion of Partnership with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), through Exclusive Commercialization and License A
- Bio-Thera Strikes Strategic Deal with Jamjoom Pharma for Securing Cosentyx® Biosimilar in MENA
- Medicines and Healthcare products Regulatory Agency (MHRA) Approves Bio-Thera Solutions’ Qletli® (adalimumab), a biosimilar referencing Humira®
- The European Commission (EC) Approves Bio-Thera Solutions’ BAT2206 (USYMRO®, ustekinumab), a biosimilar referencing Stelara®
- Bio-Thera and STADA Extend Biosimilars Alliance to Tocilizumab
- Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi®
- IDMC Provides Positive Recommendation for Bio-Thera Solution’s BAT4406F (ADCC-Enhanced Anti-CD20 mAb) in Neuromyelitis Optica Spectrum Disorder Based on Interim Analysis of Pivotal Phase II/III Trial
- Bio-Thera Solutions Announces First Patient Dosed in Phase 3 Clinical Trial for BAT8006, an Antibody Drug Conjugate Targeting Folate Receptor α for the Treatment of Platinum-Resistant Ovarian Cancer
- Bio-Thera Solutions and SteinCares Expand Partnership to Commercialize Biosimilars for Treatment of Inflammatory Diseases Across Latin America
- Bio-Thera Solutions Receives Positive CHMP Opinion for USYMRO®(ustekinumab), a Biosimilar Referencing Stelara®
- Poster: Bio-Thera Solutions Presents Clinical Data for multiple products at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
- Bio-Thera Solutions and Hikma Pharmaceuticals Announce FDA Approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection
- Bio-Thera Solutions Presents Clinical Data for multiple products at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
- Bio-Thera and Dr. Reddy’s Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara® Biosimilar, and BAT2506, a Proposed Simponi® Biosimilar, for Southeast Asia
- Bio-Thera Solutions Announces Exclusive Commercialization and License Agreement with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi® (golimumab), in the United States of
- Bio-Thera and World Medicine Signs an Exclusive License and Commercialisation Agreement for BAT2206, a Proposed Stelara® Biosimilar
- Bio-Thera Solutions Publishes Phase I Clinical Study Results for BAT4406F, an ADCC-Enhanced Fully Humanized Anti-CD20 Monoclonal Antibody, in Patients with Neuromyelitis Optica Spectrum Disorders
2024
- Bio-Thera Solutions Partners with Tabuk Pharmaceuticals to Commercialize BAT2206, a Stelara® (Ustekinumab) Biosimilar in Saudi Arabia
- Bio-Thera Solutions Expands Partnership with SteinCares in LATAM with Addition of a Third Biosimilar to Partnership
- Bio-Thera and Richter Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara® Biosimilar, for EU countries, UK, Switzerland and other selected countries
- Bio-Thera Solutions and Biogen Publish Phase 3 Clinical Trial Data for TOFIDENCETM (BAT1806/BIIB800), an approved Biosimilar referencing tocilizumab in Arthritis Research & Therapy
- Bio-Thera Solutions and Pharmapark Further Expand Partnership in Russia and other CIS Countries with Addition of BAT2306, a Cosentyx® Biosimilar
- European Medicines Agency (EMA) Approves Bio-Thera Solutions’ BAT1706 (Avzivi®, bevacizumab), a biosimilar referencing Avastin®
- Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial for BAT3306, a Proposed Biosimilar of Keytruda® (Pembrolizumab)
- Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU
- Bio-Thera Solutions Receives Positive CHMP Opinion for Avzivi® (bevacizumab), a Biosimilar Referencing Avastin®
- Bio-Thera Solutions Presents Clinical Data for BAT8006 (Folate Receptor-alpha-ADC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
- Bio-Thera and STADA Reach Exclusive Agreement for BAT2506, a Proposed Golimumab Biosimilar, in the EU and UK
- Bio-Thera Solutions Announces the Launch of TOFIDENCE® (tocilizumab-bavi) in the United States
- Bio-Thera Solutions Receives IND Clearance From US FDA to Initiate a Phase II Study for BAT8006, an Innovative Antibody Drug Conjugate Targeting Folate Receptor α
- Bio-Thera Solutions Partners with SteinCares to Market Two Biosimilars in LATAM
- Bio-Thera Solutions Announces Initiation of Phase IB / IIA Clinical Trial for BAT6026, a Monoclonal Antibody Targeting OX40, in Patients with Moderate to Severe Atopic Dermatitis
- Bio-Thera Solutions Partners with Macter International to Market BAT1706, an Avastin®1 biosimilar, in Pakistan and Afghanistan
2023
- FDA Approves Bio-Thera Solutions’ Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®
- Bio-Thera Solutions Announces Positive Results from Phase 3 Study of BAT2206, a Proposed Biosimilar Referencing Stelara®
- Bio-Thera Solutions Announces GMP Approval from ANVISA
- FDA Approves TOFIDENCE® (tocilizumab-bavi) a Biosimilar of ACTEMRA® developed by Bio-Thera Solutions
- Bio-Thera Solutions Announces Positive Phase 1 Clinical Data for BAT8006 (Folate-Receptor-α-ADC) and Presents Phase 1 Dose Escalation Study at the Bethune Obstetrics and Gynecology Forum
- Bio-Thera Solutions Partners with Mega Lifesciences to Market BAT1706, an Avastin®1 biosimilar, in Indonesia
- Bio-Thera Solutions Expands Partnership with Biomm in Brazil with Addition of BAT2206, a Stelara® Biosimilar
- Bio-Thera Solutions Announces BAT1006 Poster Presentations at the 2023 AACR Annual Meeting
- Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8007, an Antibody-Drug Conjugate Targeting Nectin-4 for the Treatment of Advanced Solid Tumors
- Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8008, an Antibody-Drug Conjugate Targeting Trop2 for the Treatment of Advanced Solid Tumors
- Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8010, an Antibody Drug Conjugate Targeting HER2 for the Treatment of Advanced Solid Tumors
- China NMPA Approves Bio-Thera Solutions' BAT1806, A Biosimilar to Actemra® (Tocilizumab)
2022
- Bio-Thera Solutions Announces Presentation of BAT8009 (B7-H3-ADC) at the 2nd Annual ADC Target Selection Summit
- Bio-Thera Solutions Announces BAT8006 (Folate-Receptor-α-ADC) and BAT8008 (Trop2-ADC) Poster Presentations at the 2022 San Antonio Breast Cancer Symposium
- Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2306, a Proposed Biosimilar of Cosentyx® (Secukinumab)
- Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT2606, a Proposed Biosimilar of Nucala® (mepolizumab)
- Bio-Thera Solutions Announces Details of Poster Presentation of a Highly Thermal Stable Recombinant Bivalent Nanoparticle Vaccine Containing Spikes of SARS-CoV-2 Omicron and Delta at Vaccine Summit 20
- Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8006, an Antibody Drug Conjugate Targeting Folate Receptor α for the Treatment of Advanced Solid Tumors
- Bio-Thera Solutions Announces Enrollment Completed in Phase 1 Study for BAT2022, a Broadly Potent Neutralizing Bi-specific Antibody Against SARS-CoV-2
- Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8009, an Antibody Drug Conjugate Targeting B7-H3 (CD276) for the Treatment of Advanced Solid Tumors
- Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT7104, a Bispecific Antibody Targeting PD-L1 and CD47 for the Treatment of Advanced Solid Tumors
- Bio-Thera Solutions Announces First Patient Dosed in a Phase 1 Study in Australia Evaluating BAT6026, an Anti-OX40 Antibody with Enhanced ADCC Effect, in Combination with BAT1308, an Anti-PD-1 Antibod
- Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT6021, an ADCC-enhanced Monoclonal Antibody Targeting TIGIT for the Treatment of Solid Tumors
2021
- Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials for BAT6026, a Monoclonal Antibody Targeting OX40
- Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials for BAT6005, a Monoclonal Antibody Targeting TIGIT
- Bio-Thera Solutions Expands Partnership with Pharmapark in Russia and other CIS Countries with Addition of BAT2206, a Stelara® Biosimilar
- Bio-Thera Solutions and Intract Pharma Enter Global Collaboration and License Agreement for Soteria® and Phloral® Drug Delivery Technologies to Enable Development of Oral Antibody Medicines
- Bio-Thera Solutions Announces Commercialization and License Agreement for BAT1706, a Proposed Biosimilar Referencing Avastin® (Bevacizumab)
- Bio-Thera Solutions and Hikma Pharmaceuticals announce exclusive commercialization and license agreement for BAT2206 in the US, a proposed biosimilar referencing Stelara® (ustekinumab)
- Bio-Thera Solutions Announces the First Patient Dosed in Phase III Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)
- Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi® (Golimumab)
- Biogen and Bio-Thera Announce Positive Results From Phase 3 Study of BAT1806, a Proposed Biosimilar Referencing Actemra® (Tocilizumab)
- BIOGEN AND BIO-THERA SOLUTIONS ANNOUNCE COMMERCIALIZATION AND LICENSE AGREEMENT FOR PROPOSED BIOSIMILAR CURRENTLY IN PHASE 3 WITH THE POTENTIAL TO TREAT MODERATE TO SEVERE RHEUMATOID ARTHRITIS
- Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT1706, a Proposed Biosimilar to Avastin®
2020
- Bio-Thera Solutions Partners with Biomm to Market BAT1706 in Brazil
- Bio-Thera Solutions Submits Marketing Authorization Application (MAA) for BAT1706, a Proposed Biosimilar to Avastin®, to European Medicines Agency (EMA)
- Bio-Thera Solutions and BeiGene Announce License, Distribution, and Supply Agreement for Avastin® (Bevacizumab) Biosimilar BAT1706 in China
- Bio-Thera Solutions Partners with Pharmapark to Market BAT2506 in Russia and other CIS Countries
- NMPA Accepts Bio-Thera Solutions' Biologics License Application (BLA) for BAT1706, A Proposed Biosimilar to Avastin®
- Bio-Thera Solutions Announces Positive Top-Line Results for BAT1706, A Proposed Biosimilar to Avastin®
- Bio-Thera Solutions Launches First Commercial Product, QLETLI® (格乐立®), in China
2019
- Bio-Thera Solutions Announces NMPA approval of IND Application to Initiate Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)
- China NMPA Approves Bio-Thera Solutions' QLETLI®, A Biosimilar To Humira® (Adalimumab)
- Bio-Thera Solutions Announces Two Poster Presentations at the 2019 AACR Annual Meeting
- Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for BAT1806, a Proposed Biosimilar of Actemra® (Tocilizumab)
- Bio-Thera Solutions Ltd Partners with Cipla Ltd to Market Key Cancer Biosimilar
- Bio-Thera Solutions Files IND for Phase 1 Clinical Trial with BAT8003 (Trop2-ADC) as Treatment for Trop2 Positive Cancers
2018
- Bio-Thera Solutions Announces BAT8001 and BAT8003 Poster Presentations at the 2018 San Antonio Breast Cancer Symposium
- Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT4306F, an ADCC-enhanced CD20 monoclonal antibody
- Bio-Thera Solutions Announces Poster Presentation at the 2018 EORTC-NCI-AACR Symposium
- Bio-Thera Solutions Announces Initiation of Pivotal Phase III Study of BAT8001 for Patients with Metastatic Breast Cancer
- Bio-Thera Solutions Announces China National Drug Administration Acceptance of Biologics License Application for Proposed Biosimilar to Humira® (Adalimumab)
- Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT-1806, a Proposed Biosimilar of Actemra® (Tocilizumab)
- BAT4306F Approved for Phase I Clinical Trials in China
- Bio-Thera Solutions Announces Two Poster Presentations at the 2018 AACR Annual Meeting
- Bio-Thera Solutions to Present at the Biotech Showcase 2018 Conference on January 10, 2018
2016
- Bio-Thera's Recombinant Humanized anti-HER2 Monoclonal Antibody-Maytansine Conjugates for Injection's Approved for Clinical Trials in China
- Bio-Thera Reaches a Strategic Cooperation Agreement With Quintiles
- BAT1706 (Bevacizumab Biosimilar) Approved for Phase I Clinical Trials in China
- BAT1706 (Bevacizumab Biosimilar) Phase I Trial Enrolls Its First Subjects in NZ