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FibroGen Inc. Enters Restructuring Mode After Late-Stage Trial Failures for Pamrevlumab
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US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all…
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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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Gan & Lee Pharmaceuticals Gains Market Foothold in Algeria with Insulin Product Approvals
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Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company, has announced that it has received registration approval from Algerian authorities for two of its insulin products: the insulin aspart injection pre-filled pen and the insulin aspart 30 injection pre-filled pen. These products are slated to be manufactured locally by…
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Cutia Therapeutics’ CU-30101 NDA Accepted for Review by China’s NMPA
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Cutia Therapeutics (HKG: 2487), a company specializing in dermatological treatments, has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for CU-30101, a topical lidocaine and tetracaine cream. This pharmaceutical product is designed to provide rapid and long-lasting anesthetic effects, leveraging the…
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Novartis’s Scemblix Receives FDA Priority Review for First-Line CML Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced that the US Food and Drug Administration (FDA) has granted priority review status to Scemblix (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP). Scemblix, the first molecule to specifically target the ABL Myristoyl…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-A1921 Clinical Study in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its innovative antibody drug conjugate (ADC), SHR-A1921. The study will evaluate the efficacy and safety of SHR-A1921…
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Organon’s Liptruzet Launches in China for Hypercholesterolemia Treatment
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US pharmaceutical company Organon (NYSE: OGN) has announced the official market launch of its single-tablet compound preparation Liptruzet (ezetimibe, torvastatin) in China for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). The launch marks a significant step in addressing the lipid management needs of Chinese patients. Liptruzet combines the…
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EU Regulator Rejects Marketing Authorization for Biogen and Eisai’s Alzheimer’s Drug Leqembi
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Biogen Inc. (NASDAQ: BIIB), a US biotechnology company, and its Japanese counterpart Eisai Co., Ltd have encountered a setback in their efforts to secure European approval for Leqembi (lecanemab), an Alzheimer’s disease therapy. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative…
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Luye Pharma’s Antipsychotic Erzofri Gains FDA Nod for Schizophrenia Treatment
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has achieved a significant milestone with the US Food and Drug Administration’s (FDA) marketing approval of its in-house developed antipsychotic medication, Erzofri (paliperidone palmitate extended-release injectable suspension). The approval grants Erzofri the clearance for treatment of schizophrenia and…
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3SBio’s Thrombopoietin Meets Primary Endpoint in Phase III Trial for Chronic Liver Disease Patients
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3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced the successful conclusion of the Phase III TPO106 clinical trial for its thrombopoietin drug in patients with chronic liver disease associated thrombocytopenia who are scheduled for invasive surgery. The trial has met its pre-set primary endpoint, paving the…
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CStone Pharmaceuticals’ Sugemalimab Wins EU Nod as First-Line NSCLC Treatment
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CStone Pharmaceuticals (HKG: 2616), a leading biopharmaceutical company based in China, has received marketing approval from the European Commission (EC) for its PD-L1 inhibitor, Cejemly (sugemalimab). The approval covers the drug’s use in combination with platinum-based chemotherapy as a first-line treatment for adults with metastatic non-small-cell lung cancer (NSCLC), excluding…
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Alphamab’s KN057 Earns FDA Orphan Drug Designation for Hemophilia B Treatment
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has received another orphan drug designation (ODD) from the US FDA for its monoclonal antibody (mAb) KN057, which targets the tissue factor pathway inhibitor (TFPI). This new ODD is for the potential treatment of hemophilia B, following the initial ODD…
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Junshi Biosciences’ Toripalimab Recommended for EU Approval for Two Indications
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for two new indications of its PD-1 inhibitor, Loqtorzi (toripalimab). The first is in combination with cisplatin and gemcitabine for first-line treatment of…
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Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options
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Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This…
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Hengrui Pharmaceuticals Advances in Breast Cancer Treatment with NMPA Clinical Trial Greenlight
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a pharmaceutical heavyweight based in China, has received approval from the National Medical Products Administration (NMPA) to commence clinical studies on its innovative drug candidates. The study will explore the synergistic effects of HRS-6209 in combination with HRS-1358, HRS-8080, or aromatase inhibitors, and…
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Zhejiang Haichang Biotech Secures EU Approval for Apexelsin: A New Hope in Cancer Treatment
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Zhejiang Haichang Biotech Co., Ltd, a partner of China-based Kexing Pharmaceutical (SHA: 688136), has secured marketing approval from the European Commission for its biosimilar, Apexelsin. This groundbreaking treatment, which mirrors the quality of BMS/Celgene’s Abraxane (paclitaxel, albumin-bound), is indicated for metastatic breast cancer, metastatic pancreatic cancer, non-small cell lung cancer,…
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Belief BioMed’s Hemophilia B Gene Therapy BBM-H901 Slated for Priority Review in China
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The Center for Drug Evaluation (CDE) has indicated on its website that the market application for BBM-H901, a gene therapy treatment for hemophilia B developed by Belief BioMed Group (BBM), a Shanghai-based specialist in gene therapy, is on track for priority review. BBM-H901, co-developed with Japan’s Takeda, is an adeno-associated…
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Sinqi Pharmaceutical Gets NMPA Green Light for SQ-22031 Eye Drops to Treat Dry Eye Syndrome and Neurotrophic Keratitis
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Shenyang Sinqi Pharmaceutical Co., Ltd (SHE: 300573), a pharmaceutical company based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its therapeutic biologic, SQ-22031 eye drops. This Category 1 therapeutic biologic is intended for the treatment of dry eye syndrome and neurotrophic keratitis, with…
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China’s NMPA Gives Tacit Nod to IASO Biotechnology’s IASO-782 for SLE Clinical Trials
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has granted tacit approval for its Investigational New Drug (IND) application for IASO-782. The company’s injectable drug candidate is slated for clinical trials in China to evaluate its efficacy in treating systemic lupus…
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Luye Pharma’s Subsidiary Gets NMPA Go-Ahead for First CD228-Targeted ADC BA1302
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Shandong Boan Biotechnology Co., Ltd (HKG: 6955), a subsidiary of China-based Luye Pharma Group (HKG: 2186), has received approval from the National Medical Products Administration (NMPA) to commence a Phase I clinical trial for its proprietary antibody-drug conjugate (ADC), BA1302. The trial, which is multi-center, open-label, and involves multiple dosages…
