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Chongqing Genrix Biopharmaceutical Gets NMPA Clearance for IL-4Rα mAb Candidate GR1802
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Chongqing Genrix Biopharmaceutical Co., Ltd (SHA: 688443), a Chinese biopharmaceutical company, has announced that it has received clinical trial clearance from the National Medical Products Administration (NMPA) for its investigational drug candidate GR1802, an interleukin-4 receptor α (IL-4Rα) monoclonal antibody (mAb). The drug is intended to be assessed as a…
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Sichuan’s Ancocare Gets FDA Green Light for Phase I/III Study of Oncolytic Virus in Neuroblastoma
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Sichuan-based Flavivirus technology platform developer Ancocare has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I/III clinical study for its double spear type I oncolytic virus DS1-H2-1 in neuroblastoma. The product, which leverages the Flavivirus technology platform, is a positive…
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Yantai Dongcheng’s Radiopharmaceutical 68GaLNC1007 Gets FDA Nod for Diagnostic Use in Solid Tumors
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) for its radiopharmaceutical 68GaLNC1007. This diagnostic agent targets fibroblast activating protein (FAP) and integrin αvβ3 and is under development to support the treatment…
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Shanghai Fosun Pharmaceutical Receives NMPA Approval for Phase II Study of FCN-338 for Light Chain Amyloidosis
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study for its pipeline drug candidate, FCN-338. This small-molecule Bcl-2 inhibitor will…
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Roche Commences Phase II Trial of Repare Therapeutics’ ATR Inhibitor, Camonsertib, in Solid Tumors
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Swiss pharmaceutical giant Roche (SWX: ROG) has reached a significant milestone this week with the dosing of the first patient in an open-label Phase II trial using its Canadian partner Repare Therapeutics’ (NASDAQ: RPTX) ATR inhibitor, camonsertib. The trial aims to evaluate the safety and efficacy of various targeted therapies…
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Biosion’s SIRPα-Targeting Monoclonal Antibody BSI-082 Clears US FDA Clinical Trial Hurdle
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Biosion, a global clinical-stage biotechnology company dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its pipeline candidate BSI-082. This monoclonal antibody (mAb) targets SIRPα and is under development for the…
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IASO Biotherapeutics Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
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China-based IASO Biotherapeutics has received clinical trial approval from the National Medical Products Administration (NMPA) for its BCMA-directed CAR T cell therapy, Fucaso (equecabtagene autoleucel), now indicated for the treatment of refractory systemic myasthenia gravis (MG). Originally approved for marketing in China in June 2022 for recurrent and refractory multiple…
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MSD’s Keytruda Combines with PharmAbcine’s PMC-309 in Phase Ia/b Solid Tumor Trial
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its blockbuster anti-PD-1 drug Keytruda (pembrolizumab) has entered a Phase Ia/b trial in combination with South Korea-based PharmAbcine’s (KOSDAQ: 208340) VISTA-inhibiting biologic PMC-309 for the treatment of advanced or metastatic solid tumors. The study aims to determine the recommended dose,…
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China Grand Pharmaceutical Gets NMPA Green Light for mRNA Cancer Vaccine ARC01 Phase I Study
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, dosage escalation Phase I study for its therapeutic cancer vaccine ARC01 (A002). The study will assess the safety, tolerability, immunogenicity, pharmacokinetics, and…
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Lingyi Biotechnology’s Gene Therapy Candidate LY-M001 Gets FDA Green Light for Gaucher’s Disease
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Lingyi Biotechnology Co., Ltd, a China-based gene therapy developer, has secured clinical trial approval from the US Food and Drug Administration (FDA) for its proprietary AAV gene therapy candidate, LY-M001, which is being developed to treat type I or III Gaucher’s disease. LY-M001 utilizes a recombinant adeno-associated virus (rAAV) as…
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Zhaoke Ophthalmology Secures NMPA Approval for Presbyopia Treatments Brimochol PF and CarbacholPF
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for two of its products, Brimochol PF and CarbacholPF, which are designed to treat presbyopia. Brimochol PF and Carbachol…
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Harbour BioMed Gets FDA Green Light for Phase I Study of BsAb Targeting PD-L1 and CD40
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Harbour BioMed (HKG: 2142), a biotechnology company with operations in Suzhou, China, Cambridge in the US, and the Netherlands, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and anti-tumor…
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BriSTAR Immunotech’s LILRB4-Targeted Cell Therapy YTS104 Gets Tacit Approval for Clinical Trial in China
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BriSTAR Immunotech, a clinical-stage cell therapy company based in Beijing, has received tacit clinical trial approval from the Center for Drug Evaluation (CDE) in China for its YTS104, a specific LILRB4-targeted cell therapy based on its STAR-T platform. The targeted indications for YTS104 include recurrent/refractory acute myeloid leukemia (AML), chronic…
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Hansoh Pharmaceutical Gets NMPA Approval for Type 2 Diabetes and Obesity Drug Trial
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692), a leading Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) in China to commence a clinical study of its Category 1 drug candidate, HS-10501. The study aims to assess the efficacy and safety of…
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Abbott Initiates Clinical Study for Volt PFA System in Australia for Cardiac Arrhythmias
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Abbott (NYSE: ABT) has announced that the first patients have been treated with its Volt pulsed field ablation (PFA) system as part of a clinical study in Australia. The study is designed to evaluate the safety and effectiveness of the device in treating common cardiac arrhythmias such as atrial fibrillation…
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Tasly Pharmaceuticals Gets NMPA Go-Ahead for Clinical Trial of Stem Cell Therapy in Heart Failure
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Tasly Pharmaceuticals (SHA: 600535), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its human umbilical cord mesenchymal stem cell injection, B2278. The study aims to evaluate the efficacy of this therapy…
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Sinocelltech Granted NMPA Approval for Phase I Clinical Trial in Hematological Malignancies
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Sinocelltech Group Ltd (SHA: 688520), a biopharmaceutical company based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its monoclonal antibody SCTC21C, targeting CD38+ hematological malignant tumors. This development marks a significant step forward in…
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Luzhu Biotechnology’s LZ901 Herpes Zoster Vaccine Trial Fully Enrolls 26,000 Participants
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Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a leading manufacturer of human vaccines and therapeutic biologics, has declared the successful completion of patient enrollment for the Phase III clinical study of its vaccine candidate LZ901 in China. Over 98% of the participants have received the requisite two doses of either…
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Beijing Aosaikang Initiates Phase III Trial for Advanced Gastric Cancer Treatment
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has registered a Phase III clinical study with Clinicaltrials.gov for its Claudin18.2-targeted antibody ASKB589. The trial will investigate the use of ASKB589 in combination with tislelizumab and chemotherapy as a first-line treatment for advanced gastric cancer. The study aims…
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Shanghai-Based NK CellTech Earns FDA IND Clearance for Non-Genetically Modified NK Cell Therapy
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NK CellTech, a Shanghai-based developer of NK cell therapies, has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its proprietary non-genetically modified natural killer cell therapy, NK010, for the treatment of ovarian cancer. This milestone marks NK CellTech as…
