Bio-Thera Solutions, Ltd.

30 articles with Bio-Thera Solutions, Ltd.

• Bio-Thera Solutions Expands Partnership with Pharmapark in Russia and other CIS Countries with Addition of BAT2206, a Stelara® Biosimilar

  10/15/2021

  Bio-Thera Solutions, Ltd. (688177:SH), today announced the company has reached licensing and supply agreements with Pharmapark LLC, for BAT2206, its ustekinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries.

• 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

  9/27/2021

  Bio-Thera Solutions, Ltd. (688177.SH, “Bio-Thera”) and Intract Pharma (“Intract”) announced a global collaboration and licensing agreement that gives Bio-Thera access to Intract’s Soteria® and Phloral® drug delivery technologies to develop novel oral monoclonal antibody (mAb) treatments for chronic gastrointestinal (GI) inflammatory diseases.

• Bio-Thera Solutions Announces Commercialization and License Agreement for BAT1706, a Proposed Biosimilar Referencing Avastin® (Bevacizumab)

  9/8/2021

  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)

  8/27/2021

  Bio-Thera Solutions, Ltd. and Hikma Pharmaceuticals PLC announced that they have entered into a commercialization and license agreement to commercialize BAT2206, a monoclonal antibody that is a proposed biosimilar referencing Stelara®, in the United States.

• Bio-Thera Solutions Reported the Discovery of a Broad-Spectrum SARS-CoV-2 Neutralizing Antibody with Potential to Treat Many Known Variants of COVID-19

  8/11/2021

  Bio-Thera Solutions, Ltd. announced the discovery of a broad-spectrum SARS-CoV-2 neutralizing antibody with the potential to treat COVID-19.

• Bio-Thera Solutions Announces the First Patient Dosed in Phase III Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)

  7/15/2021

  Bio-Thera Solutions, Ltd. today announced that the first patient has been dosed in a Phase III clinical study for BAT2206, a proposed biosimilar of Stelara® (ustekinumab).

• Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi® (Golimumab)

  6/8/2021

  Bio-Thera Solutions, Ltd. today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi® (golimumab).

• 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

  4/8/2021

  Biogen enters into a commercialization and license agreement to develop, manufacture and commercialize BAT1806, a proposed biosimilar referencing ACTEMRA ® (tocilizumab) Biosimilars have the potential to enable greater access to marketed biologic therapies while generating cost savings and healthcare sustainability

• Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT1706, a Proposed Biosimilar to Avastin®

  1/28/2021

  Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT1706, a Proposed Biosimilar to Avastin ®

• Bio-Thera Solutions Submits Marketing Authorization Application (MAA) for BAT1706, a Proposed Biosimilar to Avastin®, to European Medicines Agency (EMA)

  11/25/2020

  Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, today announced that it has submitted the MAA for BAT1706, a proposed biosimilar to Avastin® (bevacizumab), to EMA.

• Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)

  9/3/2020

  Bio-Thera Solutions (688177.SS), a commercial-stage biopharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed biosimilar of Stelara® (ustekinumab), to US-sourced and EU-sourced reference product in normal he

• Bio-Thera Solutions and BeiGene Announce License, Distribution, and Supply Agreement for Avastin® (Bevacizumab) Biosimilar BAT1706 in China

  8/24/2020

  Aug. 24, 2020 12:08 UTC Bio-Thera Solutions and BeiGene Announce License, Distribution, and Supply Agreement for Avastin ® (Bevacizumab) Biosimilar BAT1706 in China GUANGZHOU & BEIJING & CAMBRIDGE, Mass--( BUSINESS WIRE )-- Bio-Thera Solutions, Ltd., a commercial stage biopharmaceutical company (688177.SH) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), today announced that the companies have executed a license, distribution, and supply agreement for China for Bio-Thera’s B

• Bio-Thera Solutions Partners with Pharmapark to Market BAT2506 in Russia and other CIS Countries

  7/17/2020

  Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has reached a licensing agreement with Pharmapark LLC, for BAT2506, its golimumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and othe

• NMPA Accepts Bio-Thera Solutions’ Biologics License Application (BLA) for BAT1706, A Proposed Biosimilar to Avastin®

  6/20/2020

  Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin® (bevacizumab). Bio-Thera seeks commercial license for all approved indications of bevacizumab in China, advanced, metastatic or relapsed non-small cells lung cance

• Bio-Thera Solutions Announces Positive Top-Line Results for BAT1706, A Proposed Biosimilar to Avastin®

  2/3/2020

  Results from the Comparative Phase III Clinical Study Demonstrate Equivalence in Patients with Non-squamous Non-small Cell Lung Cancer

• Bio-Thera Solutions Launches First Commercial Product, QLETLI® (格乐立®), in China

  1/10/2020

  Bio-Thera Solutions, Ltd., a fully-integrated pharmaceutical company, announced that QLETLI®, a biosimilar to Humira®, is now available in China.

• Bio-Thera Solutions Announces NMPA approval of IND Application to Initiate Phase I Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara® (Ustekinumab)

  12/4/2019

  Bio-Thera Solutions, Ltd., a clinical-stage pharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a Phase I clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed biosimilar of Stelara® (ustekinumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.

• China NMPA Approves Bio-Thera Solutions’ QLETLI® (格乐立®), A Biosimilar To Humira® (Adalimumab)

  11/7/2019

  Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration has approved QLETLI® for all eligible indications of the reference product, Humira®, in China.

• Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi® (Golimumab)

  8/14/2019

  Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2506, a proposed biosimilar of Simponi® (golimumab), to EU-sourced Simponi® in normal healthy volunteers.

• Bio-Thera Solutions Announces Two Poster Presentations at the 2019 AACR Annual Meeting

  3/27/2019

  Bio-Thera Solutions, a clinical-stage biopharmaceutical company developing a pipeline of innovative oncology therapies and a pipeline of biosimilars, today announced the company will present two posters at the 2019 American Association for Cancer Research ("AACR") Annual Meeting taking place March 29 - April 3, 2018 in Atlanta, Georgia.