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Allist Pharmaceuticals’ Furmonertinib Receives NMPA Approval for Two Clinical Trials
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Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) has announced two clinical trial approvals from the National Medical Products Administration (NMPA) for its drug furmonertinib, a third-generation epidermal growth factor receptor (EGFR) inhibitor. The approvals allow for the initiation of a clinical study as a first-line treatment for exon 20 insertion mutated…
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Everest Medicines’ Nefecon NDA Accepted for Review by Singapore’s HSA
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China-based Everest Medicines (HKG: 1952) has announced that the Health Sciences Authority (HSA) of Singapore has accepted for review the New Drug Application (NDA) for its Nefecon (targeted-release formulation-budesonide) for adult patients with IgA nephropathy at risk of disease progression. The drug is anticipated to receive approval within the year.…
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Hutchison China Meditech Initiates Two Phase II Studies for HMPL-453 and Orpathys
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China-based Hutchison China Meditech (HutchMed, NASDAQ: HCM, HKG: 0013) has announced that the first subjects have been dosed in two separate Phase II regulatory studies. The first study is for the pipeline candidate HMPL-453, which is being assessed as a treatment for advanced intrahepatic cholangiocarcinoma with fibroblast growth factor receptor…
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Evopoint Biosciences Partners with Merck for Phase Ib/II Study Combining XNW5004 and Keytruda
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China-based Evopoint Biosciences has announced a collaboration agreement with US major Merck Sharp & Dohme (MSD, NYSE: MRK). The agreement will permit Evopoint to conduct a Phase Ib/II clinical study assessing the combination of the EZH2 inhibitor XNW5004 with MSD’s anti-PD-1 drug Keytruda (pembrolizumab) in advanced solid tumors. XNW5004: A…
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AstraZeneca and HKSTP Expand Collaboration with MoU to Support Start-Ups
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) and Hong Kong Science and Technology Parks Corp. (HKSTP) have signed a memorandum of understanding (MoU) to strengthen their existing collaboration. This deal builds upon an earlier collaboration signed in February 2021 and will see AstraZeneca and HKSTP supporting and providing services to…
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CStone Pharmaceuticals’ Sugemalimab Files for New Indication with NMPA for Esophageal Cancer
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its programmed death-ligand 1 (PD-L1) antibody, sugemalimab. The drug is proposed as a treatment for first-line unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).…
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Biosion Receives FDA Approval for Phase II Study of TSLP mAb BSI-045B
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Global, clinical-stage biotech company Biosion, dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) BSI-045B. The in-house developed BSI-045B is intended…
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Shanghai Best-Link Bioscience Secures $29 Million in Series A Financing for Nano Drug Innovation
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Shanghai Best-Link Bioscience, LLC, a leading nano drug and drug delivery-focused enterprise based in Shanghai, has reportedly raised close to RMB 200 million (USD 29 million) in a Series A financing round. The funding round was led by Lapam Capital, with significant contributions from Hui Ding Capital and TigerYeah Capital.…
