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Bio-Thera Solutions Receives NMPA Approval for CTLA-4 and PD-1 Inhibitor Combo Study
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its BAT4706, a cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody (mAb), in combination with its programmed death-1 (PD-1) inhibitor BAT1308. The study will focus…
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Shanghai Pharmaceuticals Gets NMPA Green Light for Recombinant Human Adenovirus Type 5 Trial
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Shanghai Pharmaceuticals (HKG: 2607; SHA: 601607), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its recombinant human adenovirus type 5 in the treatment of malignant ascites. The filing for this trial was accepted for review…
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Nanjing Immunophage Biotech’s IPG11406 Approved for SLE Clinical Trial in China
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Nanjing Immunophage Biotech Co., Ltd, a China-based biotechnology company, has announced that it has received clinical trial approval from the Center for Drug Evaluation (CDE) for its in-house developed Category 1 pipeline candidate, IPG11406. This small molecule is intended to be assessed as a treatment for systemic lupus erythematosus (SLE)…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-A1811 and Pyrotinib Combo 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 conduct a Phase Ib/II clinical study. The study will assess the safety, tolerability, and efficacy of SHR-A1811 in combination with the small-molecule HER2 inhibitor pyrotinib for the treatment…
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Mabwell Bioscience Receives NMPA Approval to Launch 9MW2921 Clinical Study
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its novel antibody-drug conjugate (ADC), 9MW2921. Next-Generation ADC Based on Mabwell’s IDDC Platform9MW2921 is a next-generation ADC that leverages…
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Betta Pharmaceuticals’ MCLA-129 Combo Therapy for NSCLC Gets NMPA Clinical Approval
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its bispecific antibody, MCLA-129, in combination with befotertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The treatment…
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Pfizer Launches Phase III Trial for Quadrivalent Influenza modRNA Vaccine in Argentina
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Global pharmaceutical giant Pfizer (NYSE: PFE) has commenced recruitment in Argentina for a Phase III clinical trial evaluating the efficacy of its quadrivalent influenza modified RNA (modRNA) vaccine in comparison to a conventional quadrivalent influenza vaccine. This double-blind study aims to recruit between 1,500 to 2,000 participants who are above…
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Zai Lab Initiates Phase III Trial for Bemarituzumab in First-Line Gastric Cancer Treatment
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China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced the first patient dosing in the global regulatory Phase III FORTITUDE-101 trial for its drug candidate bemarituzumab, which is being studied for the treatment of first-line gastric cancer in China. Bemarituzumab’s Mechanism and Potential ImpactBemarituzumab is a potential…
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GRIT Biotechnology’s GT201 TIL Therapy Approved for Clinical Studies by China’s CDE
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The Center for Drug Evaluation (CDE) website has indicated that GRIT Biotechnology, a China-based cell therapy specialist, has received approval for its in-house developed gene engineered tumor-infiltrating lymphocyte (TIL) therapy, GT201, for clinical studies in patients with recurrent or metastatic solid tumors. Optimal Structural Design and Custom Retroviral System for…
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Jiangsu Hengrui Pharmaceuticals’ Irinotecan and Bupivacaine Liposome Injections Get Clinical Trial Green Light in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark a significant step forward in the development of these targeted therapies. Irinotecan Liposome Injection for Advanced Colorectal Cancer…
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Jiangsu Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Irinotecan and Bupivacaine Liposome Injections
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark significant steps in advancing the company’s pipeline in oncology and pain management. Irinotecan Liposome Injection for Advanced Colorectal…
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Hrain Biotechnology’s Anti-CD70 T Cell Therapy HR010 Gets Tacit Approval for Renal Cancer Trial
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Shanghai-based Hrain Biotechnology Co., Ltd. has announced receiving tacit clinical trial approval from the Center for Drug Evaluation (CDE) for its anti-CD70 T cell therapy, HR010. The therapy is intended for the treatment of advanced or metastatic renal cancer. CD70 as a Potential Target for Kidney Cancer TreatmentCD70, a member…
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C4 Therapeutics’ CFT8919 Earns FDA Approval for Clinical Trials Targeting EGFR L858R Mutations
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US-based C4 Therapeutics Inc., (NASDAQ: CCCC) has announced receiving clinical trial approval from the US FDA for its pipeline candidate, CFT8919. This orally bioavailable BiDAC degrader is designed to target EGFR L858R mutations and has demonstrated good activity and selectivity against solid tumors carrying these mutations. Pre-Clinical Success and Potential…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-9815 Radiodiagnostic Drug Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its injectable HRS-9815 and the accompanying preparatory kit. The product candidate is an in-house developed Category 1 radiodiagnostic drug. HRS-9815: A Radiodiagnostic…
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Broncus Medical Inc. Launches First Regulatory Clinical Study for Targeted Lung Denervation System
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China-based Broncus Medical Inc., (HKG: 2216), a provider of precision intervention solutions focused on lung diseases, has announced the start of its first regulatory clinical study for its targeted lung denervation (TLD) radiofrequency ablation system. This multi-center, randomized study will be conducted across 26 centers, aiming to assess the safety…
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HutchMed Ltd Initiates Phase I Clinical Study for SHP2 Inhibitor HMPL-415 in Solid Tumors
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China-based HutchMed Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of a Phase I clinical study for its investigational novel selective allosteric inhibitor, HMPL-415, which targets Src homology-2 domain-containing protein tyrosine phosphatase-2 (SHP2). The trial, aimed at assessing the molecule in general solid tumors, marked its first patient dosing…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-1703 Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its anti-interleukin-5 (IL-5) antibody, SHR-1703. The drug candidate is set to be assessed as a treatment for eosinophilic granulomatous polyangiitis, a rare…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Esflurbiprofen Patch Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its esflurbiprofen patch, a generic version of Japan firm Taisho Pharmaceutical’s Loqoa tape. The intended indication for the patch…
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Abbisko Therapeutics’ EGFR Inhibitor ABSK112 Clears FDA for Global Phase I NSCLC Study
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Shanghai-based biotech firm Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a global Phase I clinical study for its next-generation EGFR inhibitor, ABSK112, in non-small cell lung cancer (NSCLC). This development highlights the company’s progress…
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Jacobio Pharma’s KRAS Inhibitor Glecirasib Advances to Pivotal Pancreatic Cancer Trial
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China-based Jacobio Pharma (HKG: 1167) has announced that it has received the green light from the National Medical Products Administration (NMPA) to initiate a pivotal clinical study for its novel KRAS G12C inhibitor, glecirasib, in pancreatic cancer. This development marks glecirasib as the world’s first KRAS inhibitor to reach the…
