Bio-Thera Solutions, Ltd.

21 articles with Bio-Thera Solutions, Ltd.

• 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.

• Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for BAT1806, a Proposed Biosimilar of Actemra® (Tocilizumab)

  1/22/2019

  Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for its tocilizumab biosimilar, BAT1806.

• Bio-Thera Solutions Ltd Partners with Cipla Ltd to Market Key Cancer Biosimilar

  1/14/2019

  Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration, the European Medicines Agency and the United States Food and Drug Administration in 2020.

• Bio-Thera Solutions Files IND for Phase 1 Clinical Trial with BAT8003 (Trop2-ADC) as Treatment for Trop2 Positive Cancers

  12/27/2018

  Subject to NMPA acceptance, Bio-Thera Solutions plans to initiate the Phase I clinical trial early in 2019.

• Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT4306F, an ADCC-enhanced CD20 monoclonal antibody

  12/7/2018

  Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that patient dosing has begun in a Phase I clinical study of BAT4306F in relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma patients.

• Bio-Thera Solutions Announces BAT8001 (HER2-ADC) and BAT8003 (Trop2-ADC) Poster Presentations at the 2018 San Antonio Breast Cancer Symposium

  11/29/2018

  Company will present two posters at the 2018 San Antonio Breast Cancer Symposium (SABCS) taking place December 4 - 8, 2018 in San Antonio, Texas.

• Bio-Thera Solutions Announces Poster Presentation at the 2018 EORTC-NCI-AACR Symposium

  11/8/2018

  The company will present one poster at the 2018 EORTC-NCI-AACR Symposium taking place November 13 - 16, 2018 in Dublin, Ireland.

• Bio-Thera Solutions Announces Initiation of Pivotal Phase III Study of BAT8001 for Patients with Metastatic Breast Cancer

  11/1/2018

  The trial is designed to compare BAT8001 versus lapatinib combined with capecitabine which is 2nd-line standard of care for metastatic breast cancer patients in China.

• Bio-Thera Solutions Announces China National Drug Administration Acceptance of Biologics License Application for Proposed Biosimilar to Humira® (Adalimumab)

  8/20/2018

  Bio-Thera Solutions announced that the China National Drug Administration (CNDA) has accepted for review the Biologics License Application (BLA) for BAT1406

• Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT-1806, a Proposed Biosimilar of Actemra® (Tocilizumab)

  7/26/2018

  The clinical study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 130 healthy volunteers.