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Abbisko Therapeutics’ Pimicotinib Meets Primary Endpoint in Phase III MANEUVER Study for TGCT
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hanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has revealed positive top-line results from the pivotal Phase III MANEUVER study for its drug candidate ABSK021 (pimicotinib) in tendon sheath giant cell tumor (TGCT). The study, designed to assess the efficacy and safety of pimicotinib in TGCT patients suitable for systemic…
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Allist Pharma’s Partner Abbisko Receives NMPA Green Light for NSCLC Drug Trial
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for ABK3376, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). This drug is co-developed with Allist Pharmaceuticals Inc., (SHA: 688578), and is intended…
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Abbisko Therapeutics’ FGFR4 Inhibitor Irpagratinib Shows Positive Phase I Results at ESMO Congress
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has presented updates on its innovative cancer treatments at the 2024 European Society of Medical Oncology (ESMO) Congress. The company highlighted the Phase I study results for irpagratinib, a novel small-molecule FGFR4 inhibitor, in patients with FGF19 over-expressing advanced hepatocellular carcinoma…
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Abbisko Therapeutics Forecasts Profits and Revenue Boost in H1 2024 on Merck Deal
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has released a positive financial forecast for the first half of 2024. The company anticipates total revenues to amount to RMB 497 million (USD 68.34 million) over the six-month period, marking a significant uptick. Additionally, Abbisko expects to report its…
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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Abbisko and Allist Pharmaceuticals Initiate Phase II Trial for NSCLC Drug Combination
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Abbisko Therapeutics Co., Ltd (HKG: 2256) and Allist Pharmaceuticals Co., Ltd have announced the upcoming start of a multi-center, open Phase II clinical study to evaluate the combination of Abbisko’s ABSK043 and Allist’s furmonertinib in patients with advanced non-small cell lung cancer (NSCLC). The study aims to establish the optimal…
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Abbisko Therapeutics’ Irpagratinib Earns Orphan Drug Designation from US FDA for Hepatocellular Carcinoma
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its novel small-molecule FGFR4 inhibitor, irpagratinib. The designation is in recognition of the drug’s potential in treating hepatocellular carcinoma (HCC). Irpagratinib, an FGFR4 inhibitor originally discovered…
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Abbisko Therapeutics Achieves Milestone in Global Phase III Trial for Pimicotinib in Tendon Sheath Giant Cell Tumor
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the completion of subject enrollment and dosing in its ABSK021-301 study, a pivotal Phase III trial evaluating the efficacy and safety of its investigational drug ABSK021 (pimicotinib) in treating tendon sheath giant cell tumor (TGCT). This marks the first…
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Abbisko Therapeutics Reports Positive Phase I Results for ABSK061 in Solid Tumors at ESMO TAT 2024
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Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) has revealed promising outcomes from a global, multi-center Phase I trial evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor efficacy of its oral FGFR2/3 inhibitor, ABSK061, in treating solid tumors. These findings were presented at the European Society for Medical Oncology (ESMO) TAT…
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Abbisko Therapeutics Secures $70 Million Upfront Payment in Licensing Deal with Merck KGaA
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Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has declared the successful conclusion of the initial phase of a licensing agreement with Merck KGaA, concerning its proprietary colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021). As part of this agreement, Abbisko has received an upfront payment of USD 70…
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Abbisko Therapeutics’ Pimicotinib Earns Orphan Drug Designation from EMA for TGCT Treatment
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced that it has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its proprietary colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021). The drug is under development for the treatment of inoperable tenosynovial giant cell…
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Abbisko Therapeutics’ Pimicotinib Earns FDA Fast-Track Status for TGCT Treatment
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology firm, has announced that its colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021), has received fast-track designation from the US Food and Drug Administration (FDA). The drug is under development for the treatment of inoperable tenosynovial giant cell tumor (TGCT). Pimicotinib,…
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Abbisko Therapeutics Strikes Licensing Deal with Merck KGaA for CSF-1R Inhibitor Pimicotinib
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced a licensing agreement with German pharmaceutical giant Merck KGaA for its in-house developed colony stimulating factor-1 receptor (CSF-1R) inhibitor, pimicotinib (ABSK021). According to the agreement, Merck will secure an exclusive license to commercialize pimicotinib in mainland China, Hong…
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Abbisko Therapeutics Launches Phase II Trial for Pimocitinib in Advanced Pancreatic Cancer
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced the initiation of a Phase II clinical study for its Category 1 innovative drug ABSK021 (pimicotinib) in advanced pancreatic cancer in China, with the first patient now dosed. The multi-center, open-label Phase II study (ABSK021-202) is being conducted…
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Abbisko Therapeutics’ CD73 Inhibitor ABSK051 Clears for Phase I Clinical Trial in China
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its next-generation CD73 inhibitor, ABSK051, in China. This first-in-human (FIH), multi-center, open-label study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD),…
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Abbisko Therapeutics Receives FDA Approval for Phase I Study of FGFR4 Inhibitor ABSK012
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical study of its next-generation FGFR4 mutant inhibitor, ABSK012, for the treatment of advanced solid tumors. Objectives of the Phase I…
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Abbisko Therapeutics to Present CSF-1R Inhibitor ABSK021 Data at CTOS Annual Meeting
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it will present data from two clinical studies on its next-generation CSF-1R inhibitor, ABSK021 (pimicotinib), at the Connective Tissue Oncology Society (CTOS) annual meeting. The presentations will highlight significant findings from the Phase Ib clinical study and the ongoing…
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Abbisko Therapeutics Gets NMPA Approval for Phase I Study of ABSK112 in NSCLC
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Shanghai-based biotechnology firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug, ABSK112. This next-generation EGFR inhibitor, which targets the Exon20ins mutation, is set to be evaluated as…
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Abbisko Therapeutics to Unveil Phase I Data for ABSK011 and ABSK043 at ESMO 2023
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Shanghai-based biotech powerhouse Abbisko Therapeutics Co., Ltd (HKG: 2256) is preparing to present the results of Phase I clinical studies for two of its pipeline candidates at the 2023 European Society for Medical Oncology (ESMO) Congress. The spotlight will be on ABSK011, a small-molecule FGFR4 inhibitor, and ABSK043, an in-house…
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Abbisko Therapeutics Gets NMPA Approval for Irpagratinib Combination Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its pipeline candidate irpagratinib (ABSK121) in combination with lenvatinib for the treatment of advanced or irresectable hepatocellular carcinoma (HCC). This development marks a…
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Abbisko Therapeutics’ Irpagratinib Receives FDA Clearance for Phase I Study in HCC
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I clinical study. The study will assess the safety, tolerability, and pharmacokinetics of its pipeline candidate, irpagratinib (ABSK121), a fibroblast growth…
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Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).…
