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Shanghai Bio-heart Launches SAKURA-SCB Study for Drug-Coated Balloon in Japan
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China-based Shanghai Bio-heart Biological Technology Co., Ltd (HKG: 2185) announced the first patient enrollment for the SAKURA-SCB study at the Cardiovascular Institute in Tokyo, Japan. This single-blinded, multiple comparison study aims to evaluate the efficacy and safety of the company’s investigational drug-coated balloon (DCB) with rapamycin. DCB InnovationThe DCB, designed…
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Sinovac Biotech’s SNA02-48 Gains Clinical Approval for Tetanus Prevention
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Beijing Sinovac Biotech Co., Ltd’s (NASDAQ: SVA) subsidiary Sinovac Life Sciences Co., Ltd. and its partner Synermore Biologics announced that their Category I new drug, SNA02-48 injection, has received clinical approval from the National Medical Products Administration (NMPA). This recombinant fully human monoclonal antibody targets tetanus toxin and offers a…
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TransThera and Akeso Biopharma Collaborate on HCC Study with Tinengotinib and Bispecific Antibodies
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Chinese companies TransThera Sciences (Nanjing) Inc. and Akeso Biopharma (HKG: 9926) have formed a strategic research collaboration to advance an open, multi-center Phase II study combining TransThera’s tinengotinib (TT-00420) with Akeso’s cadonilimab or ivonescimab for advanced hepatocellular carcinoma (HCC). The National Medical Products Administration (NMPA) has granted clearance for the…
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Huadong Medicine Gains NMPA Approval for HDM3019 Rheumatoid Arthritis Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its HDM3019 in rheumatoid arthritis (RA). This marks a significant step forward for the company in expanding its portfolio in autoimmune diseases. Drug Profile and Preclinical ResultsHDM3019…
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Hengrui Pharmaceuticals Gets NMPA Green Light for HRS-1738 and HRS-5817 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its two Category 1 chemical drugs, HRS-1738 and HRS-5817, targeting prostate cancer and overweight/obesity respectively. HRS-1738: Prostate Cancer Diagnostic InnovationHRS-1738 is an internally developed radiopharmaceutical designed for in…
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Sanofi’s mRNA Chlamydia Vaccine Gains FDA Fast Track Designation
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French pharmaceutical giant Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its mRNA vaccine candidate targeting the prevention of chlamydia infection. This designation represents a significant step forward in the development of the vaccine, which is designed to…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-9803 and SHR-A2102 Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its anti-tumor drugs SHR-9803 and SHR-A2102. This marks a significant step forward in the development of these promising therapies. SHR-9803: Targeting Regulatory T CellsSHR-9803, a Category 1 biologic…
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Guangzhou Doublle Bioproduct Receives IND Approval for E101 in Type 2 Diabetes
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Guangzhou Doublle Bioproduct Co., Ltd. has announced receiving Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) for its E101, a human umbilical cord mesenchymal stem cells (HUC-MSCs) product. The approval allows the company to initiate clinical trials for the treatment of type 2 diabetes (T2D). Product…
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Shanghai Henlius Biotech Receives NMPA Approval for HLX79 in Glomerulonephritis Trial
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China’s Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its HLX79 (E-602) in combination with Hanlikang (rituximab biosimilar) for the treatment of active glomerulonephritis. Innovation and MechanismHLX79 is a first-in-class human sialidase fusion…
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Chia Tai Tianqing’s TQB2210 Approved for Advanced Malignant Tumor Study
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Chia Tai Tianqing’s Category 1 drug TQB2210 for clinical study in advanced malignant tumors. This marks a significant step forward for the company in the field of oncology. Drug Profile and InnovationTQB2210 is a human…
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Sichuan Kelun-Biotech Gains NMPA Approval for SKB107 Bone Metastasis Trial
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate SKB107, formerly known as TBM-001. The study will focus on advanced solid tumor bone metastasis. Drug Development and MechanismSKB107 is a radionuclide…
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Abbisko Therapeutics Receives NMPA Approval for ACH Drug ABSK061
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its FGFR2/3 inhibitor ABSK061. The approval paves the way for a multi-center, non-randomized, open Phase I/II study to evaluate the drug’s safety, tolerability, pharmacokinetics, and efficacy in children…
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Humanwell Healthcare Receives NMPA Approval for Caplyta Generic in Schizophrenia Trial
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of US-based Intra-Cellular Therapies’ Caplyta (lumateperone). This Category 3 chemical drug, with no similar product approved in China, is set for evaluation in schizophrenia treatment.…
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SineuGene Therapeutics’ SNUG01 Receives FDA Clearance for ALS Clinical Study
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Beijing-based SineuGene Therapeutics, a developer of gene therapies for brain disorders, announced last week that it has received clearance from the US Food and Drug Administration (FDA) to conduct a clinical study for its lead candidate SNUG01. This best-in-class (BIC) TRIM72-targeted gene therapy will be evaluated for the treatment of…
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AllianThera Biopharma Starts Global Phase I Trial for ATB102 in Inflammatory Bowel Diseases
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Suzhou-based startup AllianThera Biopharma has announced the first patient dosing in a global Phase I clinical study for its investigational drug ATB102. The trial, a randomized, double-blinded, placebo-controlled, dose-escalation study, is designed to evaluate the safety, tolerability, and pharmacokinetics of ATB102 in healthy subjects. Drug Mechanism and InnovationATB102 is an…
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Clover Biopharmaceuticals Receives FDA Approval for SCB-1019 RSV Vaccine Trial
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced receiving clinical approval from the US Food and Drug Administration (FDA) for its SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The company has initiated the first subjects for the Phase I revaccination study, assessing the safety, reactogenicity, and…
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AIM Vaccine’s mRNA-based Shingles Vaccine Receives FDA Approval for Clinical Study
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its mRNA-based shingles vaccine. This marks a significant milestone in the company’s efforts to develop innovative vaccine solutions for global markets. Pre-Clinical Study ResultsIn pre-clinical…
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Lifetech Scientific’s LAmbre Plus LAA Closure System Gains US Medical Insurance Coverage
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China-based Lifetech Scientific Corporation (HKG: 1302) has announced obtaining medical insurance coverage in the United States for an FDA-approved pre-clinical study of its proprietary LAmbre Plus Left Atrial Appendage (LAA) Closure System. This marks the first time a home-grown left atrial appendage closure device from China has achieved this milestone.…
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Innovent Biologics Doses First Patient with IBI354 in HeriCare-Ovarian01 Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate (ADC) IBI354 to a subject in the HeriCare-Ovarian01 study. This Phase III trial is a randomized, controlled, multicenter study designed to evaluate the safety and efficacy of IBI354 compared to chemotherapy in patients with HER2-expressing…
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Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
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China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for EVM14, a tumor-associated antigen (TAA) vaccine, has been cleared by the US Food and Drug Administration (FDA). This milestone marks a significant advancement for the company’s innovative oncology pipeline. EVM14’s Mechanism and Pre-Clinical SuccessEVM14 is…
