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Guangzhou Releases First Batch of Innovative Drugs and Medical Devices List, Featuring Local Companies
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The Guangzhou Municipal Industry and Information Technology Bureau has unveiled the first batch of innovative drugs and medical devices included in the city’s list, with 24 products making the shortlist. This initiative is aimed at promoting local innovation and development within the pharmaceutical and medical device sectors. Among the notable…
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Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
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Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for BAT1706, its biosimilar version of Roche’s (SWX: RO) Avastin (bevacizumab). Under the agreement, Gedeon Richter will obtain exclusive commercialization rights for the drug in the European Union (EU), the UK, Switzerland, Australia, and other European…
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Bio-Thera Solutions’ BAT2406 Biosimilar Gets Green Light for Clinical Trials in China
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GUANGZHOU—Bio-Thera Solutions (SHA: 688177), a leading biopharmaceutical company based in Guangzhou, has received approval from the National Medical Products Administration (NMPA) to proceed with clinical studies for BAT2406, a biosimilar version of Sanofi’s Dupixent (dupilumab). This monoclonal antibody, which targets interleukin-4 (IL-4) and interleukin-13 (IL-13), is now set to be…
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Bio-Thera Solutions’ BAT8006 Receives NMPA Approval for Clinical Trial in Recurrent Ovarian Cancer Maintenance Therapy
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Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has received approval from the National Medical Products Administration (NMPA) to advance its antibody drug conjugate (ADC) BAT8006 into clinical trials in combination with bevacizumab. This trial will focus on maintenance therapy for…
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Guangzhou-Based Bio-Thera Solutions Expands Market Presence with Biosimilars and Innovative Drug Approvals
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Bio-Thera Solutions, a biotech company based in Guangzhou and listed on the Shanghai Stock Exchange (SHA: 688177), has reported its financial results for the first half of 2024. The company recorded a 27.85% year-on-year (YOY) increase in revenue, reaching RMB 402.29 million. This growth is likely due to the continued…
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Bio-Thera Solutions Expands Reach with New Licensing Deal for Biosimilar BAT2306
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has entered into a new licensing agreement with Russian firm Pharmapark LLC for BAT2306, a biosimilar of Roche’s Cosentyx (secukinumab). Under the terms of the agreement, Pharmapark will hold exclusive commercialization rights for the drug in Russia and the CIS region. Bio-Thera will oversee the…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Receives European Commission Approval
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that its biosimilar version of Roche’s Avastin, Avzivi (bevacizumab), has received market approval from the European Commission (EC). The approval encompasses all existing indications for Avastin, which include the treatment of a range of cancers such as metastatic colorectal cancer, metastatic breast cancer,…
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Bio-Thera Solutions Submits BLAs for Stelara Biosimilar BAT2206 to FDA and EMA
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Bio-Thera Solutions Ltd, a biopharmaceutical company based in Guangzhou, has announced the submission of Biologic License Applications (BLAs) to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for BAT2206, its biosimilar candidate to Johnson & Johnson’s (J&J, NYSE: JNJ) Stelara (ustekinumab), an auto-immune disease…
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Bio-Thera Solutions’ BAT2094 Wins NMPA Nod for Acute Coronary Syndrome Treatment
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous…
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Bio-Thera Solutions’ BAT1806 Biosimilar Receives European Commission Approval
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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Bio-Thera Solutions’ Bevacizumab Biosimilar Avzivi Recommended for Approval by EMA’s CHMP
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Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company based in Guangzhou, has received notification that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of its biosimilar product, Avzivi (bevacizumab), which is a biosimilar version of Roche’s Avastin. The CHMP’s positive…
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Bio-Thera Solutions Partners with STADA for European Commercialization of Golimumab Biosimilar
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced a licensing agreement with STADA Arzneimittel AG for BAT2506, a biosimilar version of Johnson & Johnson’s (J&J) Simponi (golimumab). Under this agreement, STADA will secure exclusive commercialization rights for the product across the European Union (EU), the…
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Bio-Thera Solutions Receives NMPA Approval for BAT6005 and BAT1308 Combination Therapy Trial
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors. BAT6005…
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Fosun Pharmaceutical’s Humira Biosimilar Gains New Indications with NMPA Approval
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its biosimilar drug HanDaYuan has received additional indication approvals from China’s National Medical Products Administration (NMPA). HanDaYuan, a biosimilar version of AbbVie’s Humira (adalimumab), an autoimmune disease therapy, is now approved to treat a wider range of…
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Bio-Thera Solutions’ PD-1 and ADC Combo Gets NMPA Approval for Clinical Trial in Solid Tumors
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Bio-Thera Solutions, Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for a combination therapy of BAT1308 and BAT8006 in patients with advanced solid tumors. BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal…
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Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
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Bio-Thera Solutions Reports 54.86% YOY Revenue Growth in 2023, Led by Biosimilar Sales
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Bio-Thera Solutions (SHA: 688177), a biopharmaceutical company headquartered in Guangzhou, has announced its financial results for 2023, reporting revenues of RMB 705 million (approximately USD 97.5 million), an increase of 54.86% year-on-year (YOY). This growth was largely driven by the sales of its biosimilar products: Qletli, a biosimilar version of…
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Bio-Thera Solutions and SteinCares Ink Licensing Deal for LatAm Biosimilar Distribution
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Bio-Thera Solutions (SHA: 688177), a Chinese biopharmaceutical company, has entered into a licensing agreement with SteinCares, a Costa Rican healthcare provider. Under the terms of the deal, SteinCares will obtain exclusive rights to distribute and market two of Bio-Thera’s biosimilars across Brazil and the Latin America (LatAm) region. The financial…
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Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an innovative ADC that consists of…
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Bio-Thera Solutions Receives NMPA Approval for Three Cancer Treatments Including a Novel ADC
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for three of its drug candidates. These include BAT8010 in combination with BAT1006 for the treatment of locally advanced or metastatic solid tumors, as well as BAT7205 as…
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Bio-Thera Solutions Receives NMPA Approval for Combined Phase Ib/II Study of BAT7104 and BAT4706
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Bio-Thera Solutions Ltd (SHA: 688177), a Chinese biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a combined Phase Ib/II clinical study for its pipeline drugs BAT7104 and BAT4706 in patients with advanced malignant tumors. BAT7104 is a bispecific antibody (BsAb)…
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Bio-Thera Solutions Grants Macter International Exclusive Rights to Avzivi in Pakistan and Afghanistan
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Bio-Thera Solutions (SHA: 688177), a Guangzhou-based biopharmaceutical company, has announced a licensing and commercialization agreement with Macter International Ltd., a company based in Pakistan. Under the terms of the agreement, Bio-Thera will transfer Avzivi (bevacizumab), a biosimilar version of Roche’s Avastin, to Macter. Macter will gain exclusive distribution and marketing…
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Bio-Thera Solutions Gets NMPA Green Light for PD-1 Inhibitor BAT1308 in Endometrial Cancer
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to initiate a clinical study for its programmed death-1 (PD-1) inhibitor, BAT1308, in the treatment of endometrial cancer. BAT1308 is an internally developed…
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Bio-Thera Secures FDA Approval for Avzivi, a Biosimilar to Roche’s Avastin
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received market approval from the U.S. Food and Drug Administration (FDA) for Avzivi (bevacizumab), a biosimilar version of Roche’s (SWX: ROG) Avastin. The approved indications for Avzivi include non-small cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma (GBM), renal…
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Bio-Thera Solutions’ BAT1806 Receives US FDA Approval as Biosimilar to Actemra/RoActemra
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Bio-Thera Solutions Ltd (SHA: 688177), a China-based biopharmaceutical company, announced that its biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), known as BAT1806, has passed review by the US FDA. This milestone marks the approval of BAT1806 for use in the US market to treat a range of…
