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Hopstem Biotechnology’s hNPC01 Receives Tacit Approval for Stroke Sequelae Treatment from CDE
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Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by neuroscientists and stem-cell biologists from Johns Hopkins University, has announced receiving tacit clinical trial approval from China’s Center for Drug Evaluation (CDE) for its hNPC01. This induced pluripotent stem cells (iPSC) derived cell therapy is intended for the treatment…
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BeiGene Initiates First-in-Human Trial for Next-Generation BCL-2 Inhibitor BGB-21447
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China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the first patient dosing in a first-in-human trial for its pipeline candidate, BGB-21447, a next-generation BCL-2 inhibitor. The trial, which is potentially superior to venetoclax based on preclinical activity, is being conducted at Shandong Hospital. Phase I Study Design and…
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Bio-Thera Solutions’ PD-1 Inhibitor BAT1308 Approved for Cervical Cancer Clinical Trials in China
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Bio-Thera Solutions Ltd (SHA: 688177) has announced that its programmed death-1 (PD-1) inhibitor, BAT1308, has been approved to enter clinical trials for the treatment of cervical cancer in China. The molecule will be assessed in combination with platinum chemotherapy and with or without bevacizumab, as per the Chinese firm’s announcement.…
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Nanjing Leads Biolabs Receives FDA IND Approval for LBL-033 Phase I/II Clinical Trial
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China-based Nanjing Leads Biolabs Co., Ltd has revealed that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial for its pipeline candidate, LBL-033. This anti-MUC16/CD3 bispecific antibody (BsAb) is set to be investigated as a potential…
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TG ImmunoPharma Receives FDA Approval for Phase I Clinical Study of TGI-6 Bispecific Antibody
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China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its bispecific antibody (BsAb), TGI-6. This development marks a significant step forward in the company’s efforts to bring innovative immunotherapies to patients…
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IASO Bio Receives FDA IND Approval for IASO-782 for Autoimmune Disorders
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China-based IASO Bio has announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) filing for its pipeline candidate, IASO-782. This injectable drug candidate will be assessed in US clinical trials for the treatment of various autoimmune hematological disorders, including primary immune thrombocytopenia (ITP)…
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MicuRx Pharmaceuticals’ MRX-4/Contezolid Combo Receives Clinical Trial Approvals for Diabetic Foot Infection
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced receiving clinical trial approvals for its novel anti-microbial agent MRX-4, combined with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in Israel, Bulgaria, Slovakia, Croatia, Poland, and Brazil. In-House Developed Oxazolidinone AntibioticsBoth MRX-4 and contezolid are in-house developed new-generation…
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Fosun Pharma Initiates Phase II Study of HLX26 and Serplulimab Combo for Metastatic CRC
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the initiation of a Phase II clinical study in China for HLX26, an in-house developed lymphocyte activation gene 3 (LAG-3, aka CD233) inhibitor, in combination with its programmed-death 1 (PD-1) inhibitor HaiSiZhuang (serplulimab) for the treatment of metastatic…
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Jiangxi Jemincare’s JYB1907 Receives NMPA Approval for Clinical Study in Solid Tumors
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China-based Jiangxi Jemincare Group has announced that it has received approval from the China National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug, JYB1907, a monoclonal antibody (mAb) targeting GARP and TGF-β1, in patients with locally advanced malignant solid tumors. The drug had previously…
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Cytocraft Biotech’s SDT-T002 Cell Therapy Approved for Advanced Liver Cancer by NMPA
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China-based Cytocraft Biotech Development has announced that its cell therapy, SDT-T002, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of advanced liver cancer that has failed standard treatment. Cascade Primed Immune Cells (CAPRI) Cell Therapy OverviewCytocraft boasts its Cascade Primed Immune Cells (CAPRI)…
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Dartsbio Pharmaceuticals and SIMM Receive NMPA Approval for ADC DS001 Clinical Trial
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Guangdong-based antibody drug developer Dartsbio Pharmaceuticals has partnered with the Shanghai Institute of Materia Medica (SIMM) to receive tacit clinical trial approval from the National Medical Products Administration (NMPA) for their antibody drug conjugate (ADC), DS001. The molecule is set to be assessed as a potential treatment for various advanced…
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Mabwell Bioscience’s IL-11 mAb 9MW3811 Receives US FDA Clinical Trial Approval
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its drug candidate, 9MW3811. This molecule is an in-house developed IL-11 monoclonal antibody (mAb) intended for the treatment of idiopathic pulmonary fibrosis (IPF). Therapeutic…
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Hansoh Pharmaceutical Gets NMPA Approval for HIF-2α Inhibitor HS-10516 Clinical Study
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its Category 1 candidate drug, HS-10516. The trial will evaluate the small-molecule hypoxia-inducible factor 2α (HIF-2α) inhibitor as a potential treatment…
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Genevector Initiates Clinical Study for JWK001 in Neovascular Age-Related Macular Degeneration
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Chengdu-based adeno-associated virus (AAV) gene therapy developer, Genevector Biotechnology Co., Ltd., has announced the first patient dosing in a clinical study for its product candidate, JWK001. The molecule is under assessment as a potential treatment for neovascular age-related macular degeneration (nAMD). JWK001’s Mechanism of Action and Preclinical PerformanceJWK001 employs AAV…
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Convalife Pharmaceuticals Gets NMPA Approval for Generic Neratinib Clinical Study
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Shanghai-based Convalife Pharmaceuticals has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its generic version of Puma Biotechnology Inc’s neratinib. This study aims to explore the drug’s efficacy in treating advanced non-small cell lung cancer (NSCLC) patients with rare…
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Bio-Thera Solutions’ BAT6026 Receives NMPA Approval for Atopic Dermatitis Clinical Trials
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate Phase I/II clinical trials for BAT6026, an OX40 monoclonal antibody, for the treatment of atopic dermatitis (AD). The Role of OX40 in Immune Response and BAT6026’s MechanismOX40, an immune checkpoint expressed…
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Dizal Pharmaceutical’s Sunvozertinib Gets EU Approval for Global Phase III Study
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced receiving the green light from EU authorities to proceed with the global, multi-center, random-controlled Phase III WU-KONG28 study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008). The study aims to assess the drug as a first-line treatment for…
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CSPC Pharmaceutical Gets NMPA Approval for ATM Inhibitor SYH2051 Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its in-house developed Category 1 chemical drug, SYH2051. The molecule is set to be assessed in the treatment of general solid tumors. ATM…
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Abbisko Therapeutics Initiates Phase II Study for Pimicotinib in Chronic Graft-Versus-Host Disease
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in a Phase II clinical study for its Category 1 drug ABSK021 (pimicotinib), which is aimed at treating chronic graft versus host disease (cGVHD). Understanding cGVHD and the Role of CSF-1R InhibitionThe pathological and physiological…
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Zelgen Biopharmaceuticals’ ZGGS15 Earns FDA Approval for Advanced Solid Tumor Clinical Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US FDA for its bispecific antibody (BsAb), ZGGS15, which targets LAG-3 and TIGIT in advanced solid tumors. This marks ZGGS15 as the world’s first BsAb of its kind to reach the clinical…
