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Luye Pharma Initiates Phase I Study for BA1106, a CD25 Monoclonal Antibody
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China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its BA1106, an in-house developed CD25 monoclonal antibody (mAb). The study, filed by subsidiary Shandong BoAn Biotechnology Co., Ltd, is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of…
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Qilu Pharmaceutical’s QLS12004 Gains Tacit Clinical Trial Approval
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The Center for Drug Evaluation (CDE) website indicates that China-based Qilu Pharmaceutical’s Category 1 chemical drug candidate QLS12004 has obtained tacit clinical trial approval. This marks a significant step forward in the development of new treatments for solid tumors, including advanced breast cancer, which is the leading malignant cancer affecting…
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Grand Pharma Completes Patient Enrollment for STC3141 Sepsis Study
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that all patients have completed enrollment and dosing in the Phase Ib REFINE study for its drug candidate STC3141 in sepsis in Australia and Belgium. The first data readout is expected in four months’ time, marking a significant milestone in the…
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Harbour BioMed’s Anti-CCR8 Monoclonal Antibody HBM1022 Receives FDA IND Approval
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Harbour BioMed (HBM), which operates out of the Netherlands, the United States, and Suzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its in-house developed HBM1022, a novel anti-C-C chemokine receptor type 8 (CCR8) monoclonal antibody (mAb). This marks a significant milestone in the…
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Antengene Launches Phase I CLINCH Study for ATG-022 in Australia
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China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA) to commence the Phase I CLINCH study for its antibody-drug conjugate (ADC) ATG-022. The study targets advanced or metastatic solid tumors, with a focus on gastric cancer patients expressing Claudin 18.2. ATG-022: Mechanism and Preclinical…
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Henlius Begins Phase I Trial for Biosimilar HLX15 Targeting Multiple Myeloma
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Shanghai Henlius Biotech (HKG: 2696) has announced the dosing of the first subject in a Phase I clinical study for its biosimilar candidate HLX15, targeting Johnson & Johnson’s (J&J, NYSE: JNJ) blockbuster drug Darzalex (daratumumab). The study aims to evaluate the pharmacokinetics, safety, and immunogenicity of HLX15 in healthy male…
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Hengrui’s Lutetium [177Lu] Oxy-Octreotide Gains Clinical Clearance in China
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China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical clearance from the National Medical Products Administration (NMPA) for its lutetium [177Lu] oxy-octreotide. The drug is being developed to treat unresectable or metastatic, progressive, well-differentiated (G1 and G2) neuroendocrine tumors that are somatostatin receptor-positive, specifically targeting gastrointestinal and pancreatic neuroendocrine…
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Ascletis Receives FDA Approval for Phase IIa Trial of ASC10 in RSV Infection
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving approval from the US FDA to conduct a Phase IIa clinical study for its investigational drug ASC10 in patients with respiratory syncytial virus (RSV) infection. ASC10 is an oral double prodrug designed to be rapidly and completely converted in vivo into…
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Betta Pharmaceuticals Gains FDA Approval for Clinical Trial of BPI-460372
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China’s Betta Pharmaceuticals (SHE: 300558) has announced receiving clinical trial approval from the US FDA for its Category 1 drug candidate BPI-460372. The trial will evaluate the drug as a potential treatment for advanced solid tumors, marking a significant milestone in the company’s oncology pipeline. BPI-460372: Targeting the Hippo Signaling…
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RemeGen’s Telitacicept Gains FDA Approval for Phase III Study in Myasthenia Gravis
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for its novel fusion protein telitacicept in myasthenia gravis (MG). The FDA has also awarded telitacicept fast-track status, highlighting the potential significance of…
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Luye Pharma Gains CDE Approval for Goserelin Acetate Microspheres Clinical Study
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China-based Luye Pharma Group (HKG: 2186) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its goserelin acetate sustained-release microspheres for injection (LY01022, three-month long-acting dosage form). The drug will be evaluated for treating prostate and breast cancers that are suitable for…
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Haisco’s Prostate Cancer Drug HSK38008 and DPP-4 Inhibitor HSK7653 Accepted for Review
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the clinical trial filing for its Category 1 chemical drug HSK38008 oral preparation has been accepted for review by the National Medical Products Administration (NMPA). Additionally, the NMPA has accepted Haisco’s market filing for its Category 1 chemical HSK7653, according…
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HealZen Therapeutics Gains NMPA Approval for HZ-A-018 Clinical Study in Autoimmune Diseases
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Hangzhou-based HealZen Therapeutics has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 drug candidate HZ-A-018 in recurrent multiple sclerosis (RMS) and neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step forward in exploring new treatment options for these…
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JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911
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Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by its US subsidiary VITRAC Therapeutics, LLC for its small molecule aurora A kinase (AURKA) inhibitor VIC-1911. The molecule is being assessed both as a monotherapy and in combination with sotorasib for the treatment of KRAS…
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Exegenesis Bio Gains FDA Approval for Gene Therapy EXG102-031 in Wet AMD
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Hangzhou-based clinical stage gene therapy firm Exegenesis Bio has announced receiving approval from the US FDA to conduct a Phase I clinical study for its EXG102-031. The study will assess the safety, tolerability, and vision improvement potential of this once-administered gene therapy in patients with wet age-related macular degeneration (wAMD).…
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HuidaGene Receives FDA IND Approval for Ophthalmology Gene Therapy HG004
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China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from the US FDA for its ophthalmology gene therapy HG004. The company plans to initiate a global, multi-center clinical study for the drug, a single-administered, non-adeno-associated virus serotype 2 (non-AAV2) gene replacement therapy, targeting retinopathy associated…
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Ascletis Receives IND Approval for ASC10 in Monkeypox Treatment
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its ASC10, an oral double prodrug antiviral, to evaluate its potential as a treatment for monkeypox. This approval marks a significant step in expanding the therapeutic applications of…
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CSPC’s Octreotide Long-Acting Injection Approved for Acromegaly Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 2.2 chemical octreotide long-acting injection in acromegaly. This marks a significant step forward in developing more convenient treatment options for patients with this rare…
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CNBG-Virogin’s Omicron-Targeted mRNA Vaccine Approved for Clinical Trials
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CNBG-Virogin Biotech (Shanghai) Co., Ltd has announced obtaining clinical trial approval from the National Medical Products Administration (NMPA) for its Omicron variant-targeted mRNA vaccine. This marks a significant milestone in the development of COVID-19 vaccines tailored to emerging variants. Vaccine Development and InnovationThe product, China’s first COVID-19 mRNA vaccine encoding…
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Harbour BioMed Receives FDA Approval for HBM1007 Clinical Study
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China-based Harbour BioMed (HKG: 2142) has announced receiving approval from the US FDA to initiate a clinical study of its monoclonal antibody (mAb) HBM1007, a fully-human antibody targeting CD73. This marks a significant step forward in the development of innovative therapies targeting this key biomarker. HBM1007: Mechanism and DevelopmentHBM1007 is…
