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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…
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Hansoh Pharmaceutical Advances Schizophrenia Treatment with HS-10509 Clinical Trial Approval
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Hansoh Pharmaceutical (HKG: 3692) has announced that it has received approval to commence clinical trials for HS-10509, a Category 1 drug developed in-house for the treatment of schizophrenia. The specific indication for the drug will be determined through the clinical trial process.- Flcube.com
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Changchun High & New Technology Industries to Launch GenSci125 Phase I Trial in US
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Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading Chinese pharmaceutical company, has announced the upcoming initiation of a Phase I clinical study for its investigational drug GenSci125 in the United States. The study is designed to evaluate the drug’s efficacy in luteal supplementation or replacement for…
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Hengrui Pharmaceuticals Receives NMPA Approval for Phase II Cervical Cancer Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase II clinical study. The study will investigate the combination of its PD-L1 monoclonal antibody adebrelimab (SHR-1316) with concurrent chemotherapy for the treatment of locally…
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Sino Biopharmaceutical Commences Phase III Trial for Semaglutide Biosimilar in China
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading Chinese pharmaceutical company, has announced the initiation of a Phase III clinical study for its semaglutide biosimilar in China. The study is assessing the drug as a potential treatment for type 2 diabetes. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist originally developed by…
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RemeGen’s MSLN-Targeted ADC RC88 Clears to Begin Phase I/IIa Study in China
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RemeGen Co., Ltd (HKG: 9995; SHA: 688331), a leading Chinese biotech firm, has announced that it has received approval from China’s Center for Drug Evaluation (CDE) to initiate a Phase I/IIa clinical study for RC88, a mesothelin (MSLN)-targeted antibody drug conjugate (ADC). The trial will assess the safety and efficacy…
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Hope Medicine Initiates Phase II Trial for HMI-115 in Endometriosis Treatment
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Hope Medicine Inc., based in China, has announced the first patient dosing in a global Phase II clinical trial for its monoclonal antibody (mAb) HMI-115, which targets the prolactin receptor (PRL R). The study aims to evaluate HMI-115 as a treatment for endometriosis in Chinese patients. In April 2019, Hope…
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Neuboron Medtech Secures Clinical Trial Approval for First BNCT Drug in China
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Neuboron Medtech Ltd., based in China, has received clinical trial approval for its borofalan (10b) injection, as indicated on the website of China’s Center for Drug Evaluation (CDE). This marks the first boron neutron capture therapy (BNCT) to enter regulatory studies in China and the second globally, targeting recurrent malignant…
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Bayer’s Asklepios BioPharmaceutical Launches Phase II Trial for AAV Therapy in Heart Failure
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Bayer’s (ETR: BAYN) gene therapy subsidiary, Asklepios BioPharmaceutical, has initiated patient recruitment for a Phase II clinical trial of its adeno-associated virus (AAV) therapy AB-1002 targeting congestive heart failure (CHF). This placebo-controlled study aims to assess the safety and efficacy of intracoronary infusion in 90 to 150 adults with non-ischemic…
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CanSino Biologics Enrolls First Patient in Phase I Trial of Innovative Polio Vaccine
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CanSino Biologics (SHA: 688185, HKG: 6185), a China-based biotechnology firm, has announced the enrollment of its first patient in a Phase I clinical study for its recombinant polio vaccine in Australia. This candidate vaccine is a non-infectious virus-like particle (VLP) formulation, developed utilizing CanSino’s proprietary protein structure design and VLP…
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CSPC Pharmaceutical Secures FDA Approval for Clinical Study of JMT106 in GPC3-Positive Tumors
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received approval from the US FDA to commence a clinical study for its bispecific fusion protein, JMT106, targeting GPC3-positive solid tumors. JMT106 is designed to target both GPC3 and interferon receptors, aiming to elicit antibody-dependent cellular cytotoxicity (ADCC) while activating the immune…
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CARsgen Therapeutics Gets NMPA Approval for CAR-T Therapy CT011 in Hepatocellular Carcinoma
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its chimeric antigen receptor (CAR)-T therapy, CT011. The study will focus on patients with GPC3 positive stage IIIa hepatocellular carcinoma (HCC) who are…
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Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its cancer drug candidate SIM0501, intended for the treatment of advanced solid tumors. SIM0501 is a small-molecule inhibitor of ubiquitin specific peptidase 1 (USP1), a protein that is…
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Joincare Pharmaceutical’s Partner Fermion Gets NMPA Green Light for Pain Drug Clinical Study
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Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a Chinese pharmaceutical company, has announced that Fermion’s FZ008-145 has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for pain treatment in China. Fermion, which previously granted Joincare exclusive rights to the drug in Greater…
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OBI Pharma Gets US FDA Green Light for TROP2 Targeting ADC Cancer Therapy Clinical Study
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OBI Pharma (4174.TWO), partner to Biosion Inc., has announced that it has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase I/II study for its novel antibody drug conjugate (ADC) cancer therapy, OBI-992, which targets TROP2. The antibody molecules utilized in the development of…
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Jiangxi Jemincare Group Receives Clinical Trial Approvals for Two Innovative Biologics in the US and China
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Jiangxi Jemincare Group, a biopharmaceutical company based in China, has announced that it has received clinical trial approvals for two of its Category 1 therapeutic biologics, JMB2004 and JYB1931. JMB2004, a monoclonal antibody (mAb), has been approved for clinical study in the United States for the treatment of sepsis and…
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CSBIO’s Multi-Kinase Inhibitor CSCJC3456 Gets Green Light for Clinical Trials in Advanced Solid Tumors
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its small-molecule multi-kinase inhibitor, CSCJC3456. This molecule is now set to be evaluated in the context of general advanced malignant…
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Aidea Pharmaceutical Receives NMPA Approval to Clinically Test HIV-1 Treatment ACC017
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, ACC017. This molecule is now cleared for assessment as a potential treatment for HIV-1 infection when…
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Hengrui Pharmaceuticals Gets NMPA Green Light for Phase Ib/II Study of SHR-A1921 Combo in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate an open, multi-center Phase Ib/II clinical study for its injectable pipeline candidate SHR-A1921. This investigational treatment is to be used in combination with adebrelimab (SHR-1316) and SHR-8068…
