reports
Bio-Thera Solutions Expands Partnership with Biomm in Brazil with Addi...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has entered into a licensing and supply agreement with Biomm SA, for BAT2206, its ustekinumab biosimilar, under which Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera and Biomm’s partnership was initiated around a licensing and supply agreement for Biomm to distribute and market BAT1706, a bevacizumab biosimilar, in Brazil. BAT2206 i...
Bio-Thera Solutions Announces BAT1006 Poster Presentations at the 2023...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced the company will present one poster concerning Phase 1 clinical results for BAT1006 at the 2023 American Association for Cancer Research ("AACR") Annual Meeting taking place April 14 - April 19, 2023 in Orlando, Florida. The poster, entitled “A Phase I study of BAT1006, a Novel Anti-HER2 Antibody, in Patients with Locally Advanced/Metastatic Solid Tumors,” will highlight Phase I clinical data demonstrating the safety and efficacy of BAT1006 in HER2-positive c...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8007, an antibody-drug conjugate (ADC) that targets Nectin-4. The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8007. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with a...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2. The multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors aims to evaluate the safety and tolerability of BAT8008. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with adva...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8010, an antibody-drug conjugate (ADC) that targets HER2. The multicenter, open-label Phase 1 clinical study in patients with local advanced or metastatic solid tumors aims to evaluate the safety and tolerability of BAT8010. Key objectives of the study are to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in...
China NMPA Approves Bio-Thera Solutions’ BAT1806, A Biosimilar to Acte...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra® (tocilizumab), in China. BAT1806 is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world and has been approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS). BAT1806 is Bio-Thera Solutions’ third biosimilar to receive regula...
Bio-Thera Solutions Announces Presentation of BAT8009 (B7-H3-ADC) at t...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced that Jin-Chen Yu, SVP, Research will present a talk on BAT8009 (B7-H3-ADC) at the 2nd Annual ADC Target Selection Summit taking place December 6 - 8, 2022 in Boston, MA. The talk, entitled “A Novel B7-H3 ADC With Strong Bystander Effect Demonstrates Superior Tumor-Inhibition Activity,” will present preclinical data that highlight advantages demonstrated by BAT8009 as a potential treatment for cancer p...
Bio-Thera Solutions Announces BAT8006 (Folate-Receptor-α-ADC) and BAT8...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company will present two posters at the 2022 San Antonio Breast Cancer Symposium (SABCS) taking place December 6 - 10, 2022 in San Antonio, Texas. The first poster, entitled “BAT8006, a novel FRα-ADC with strong bystander effect, for the treatment of advanced solid tumor,” will present preclinical data and initial phase 1 clinical data that highlight advantages demonstrated by BAT8006 as a potenti...
Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2306, a ...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2306, a proposed biosimilar of Cosentyx® (secukinumab). The clinical study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of BAT2306 to Cosentyx® in patients with moderate to severe plaque psoriasis. Secukinumab is a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A. In the US, secukinumab is prescribed for the followin...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed biosimilar of Nucala® (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers. The clinical study is a randomized, double-blind, parallel group, single-dose study that is expected to enroll approximately 207 healthy volunteers. Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody that is admi...
Bio-Thera Solutions Announces Details of Poster Presentation of a High...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced today the details of its poster presentation at the Vaccines Summit 2022, being held from October 11-13 in Washington D.C. Bio-Thera will present research and preclinical results of a highly thermal stable recombinant bivalent nanoparticle vaccine containing spikes of SARS-CoV-2 Omicron and Delta, showing high immunogenicity and potentially offering broad cross-protection against ever evolving Covid-19 variants. Preclinical studies showed that the candidate vacci...
Bio-Thera Solutions Announces Enrollment Completed in Phase 1 Study fo...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage biopharmaceutical company, announced today that enrollment for the Phase I clinical study of BAT2022 has been completed, showing that BAT2022 is well-tolerated and there were no DLT observed up to the dose of 1500mg, the highest dose tested. BAT2022 is a broadly potent neutralizing bi-specific antibody against SARS-CoV-2. Plasma concentrations of BAT2022 were analyzed and determined, showing very favorable PK parameters, and more importantly, the plasma levels of BAT2022 in the clinical study have sh...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8009, an antibody drug conjugate (ADC) that targets B7-H3 (CD276). The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8009 and to determine the recommended phase 2 dose. B7-H3 is an immunomodulatory transmembrane N-linked glycoprotein that is overexpressed in a number of solid tumors including ...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8006, an antibody drug conjugate (ADC) that targets folic acid receptor α (FRα). The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8006 and to determine the recommended phase 2 dose. FRα is a folic acid-binding protein located on cell membranes that is overexpressed in a variety of solid tumor...
Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BAT7104, a bispecific antibody that specifically blocks the interaction of human PD-L1 and CD47 with their corresponding receptors. BAT7104 was designed to inhibit the PD-1/PD-L1 and CD47/SIRP-α pathways. By an “imbalanced” design with finely tuned binding affinity to CD47 and high affinity to PD-L1, BAT7104 is expected to avoid...
Bio-Thera Solutions Announces First Patient Dosed in a Phase 1 Study i...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6026, a highly differentiated monoclonal antibody targeting OX40 with enhanced ADCC functions, in combination with BAT1308, a proprietary anti-PD-1 antibody currently in early-stage clinical trials. “BAT6026 has demonstrated highly potent anti-tumor activity as a single agent and in combination with BAT1308 in in vivo pharmacology...
Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6021, a monoclonal antibody with enhanced ADCC targeting TIGIT in cancer cells. “BAT6021 is Bio-Thera’s third IO asset that has entered Phase 1 study in a month.” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. “We plan to explore combinations of BAT6021 with our other oncology assets to treat a broad range of cancers.” Dr. Sheng...
Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials fo...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in Phase I clinical study to compare the pharmacokinetics and safety of BAT6026, an agonist monoclonal antibody targeting OX40 in cancer patient volunteers. BAT6026 was discovered using Bio-Thera’s proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform. The Antibody Dependent Cellular Cytotoxicity (ADCC) of BAT6026 has been enhanced through significant afucosylation of BAT6026. “OX40 is an important immune-oncol...
Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials fo...
GUANGZHOU, China--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in Phase I clinical study to compare the pharmacokinetics and safety of BAT6005, a monoclonal antibody targeting TIGIT in cancer patient volunteers. BAT6005 was discovered using Bio-Thera’s proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform, and it has normal IgG1 ADCC function. “TIGIT is an immune-oncology drug target of significant interest. Preclinical data generated in support of the BAT6005 IND is very ...
Bio-Thera Solutions Expands Partnership with Pharmapark in Russia and ...
GUANGZHOU, China & MOSCOW--(BUSINESS WIRE)-- Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, 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 and Pharmapark’s partnership was initiated around a licensing and supply agreement for Pharmapark ...
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