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Abbisko Therapeutics Receives NMPA Approval for ACH Drug ABSK061
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its FGFR2/3 inhibitor ABSK061. The approval paves the way for a multi-center, non-randomized, open Phase I/II study to evaluate the drug’s safety, tolerability, pharmacokinetics, and efficacy in children…
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Abbisko Therapeutics and Allist Pharmaceuticals Partner on KRAS-G12C NSCLC Combination Therapy
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has entered into a cooperation agreement with compatriot firm Allist Pharmaceuticals Co., Ltd (SHA: 688578). The alliance aims to study the combination of Abbisko’s investigational ABSK043 and Allist’s glecirasib in patients with KRAS-G12C mutant non-small cell lung cancer (NSCLC). ABSK043: PD-L1 InhibitorABSK043…
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Abbisko Therapeutics’ ABSK131 Receives Clinical Trial Approval from China’s NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for its small molecule inhibitor ABSK131. This follows a similar approval from US regulators in December of last year. ABSK131: Promising Anti-Tumor ActivityABSK131…
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Abbisko Therapeutics Receives NMPA Approval for Irpagratinib Regulatory Study
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a regulatory study for its novel small-molecule FGFR4 inhibitor, irpagratinib. Details of the Approved TrialThe approved trial, ABSK-011-205, is…
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Abbisko Therapeutics Presents Positive Phase II Results for Pimicotinib in cGvHD at ASH
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced the presentation of preliminary Phase II study results for pimicotinib (ABSK021) in patients with chronic Graft-versus-Host Disease (cGvHD) at the 66th American Society of Hematology (ASH) annual meeting. The study focused on patientszhe who have either progressed or not responded to…
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Abbisko Therapeutics Gets FDA Green Light for Phase I Study of ABSK131 Inhibitor
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study for its small molecule inhibitor, ABSK131. This investigational drug targets PRMT5 and MTA in patients with advanced solid tumors that…
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First Patient Dosed in Abbisko’s Phase II Trial of ABSK061 and ABSK043 in FGFR2/3 Altered Tumors
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in an open, multi-center Phase II study. The study is designed to assess the safety and efficacy of its investigational drugs ABSK061 combined with ABSK043, with or without chemotherapy, in patients with metastatic or unresectable solid…
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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 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…
