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HanchorBio Receives FDA Approval for Multi-Region Clinical Study of HCB101 Fusion Protein
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Taiwan-based HanchorBio has announced receiving the green light from the US FDA to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. The non-blind, dose exploration first-in-human trial will be conducted in the US and Taiwan, focusing on assessing the safety, tolerability, pharmacokinetics, and preliminary clinical anti-tumor…
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HuidaGene Receives CDE 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 Center for Drug Evaluation (CDE) in China for its ophthalmology gene therapy, HG004. This gene replacement therapy drug utilizes a recombinant non-adeno-associated virus serotype 2 (non-AAV2) vector to deliver a functional human RPE65 gene…
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Neurophth Biotechnology Receives NMPA Approval for Phase I/II Gene Therapy Study
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Neurophth Biotechnology Ltd, a leading gene therapy specialist based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Sino-US multi-center Phase I/II study. The study will assess the safety, efficacy, and tolerability of its gene therapy NFS-02 (rAAV2-ND1) for ND1…
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CanSino Biologics Receives NMPA Approval for Bivalent COVID-19 mRNA Vaccine
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CanSino Biologics Inc., a leading Chinese vaccines specialist, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative bivalent COVID-19 mRNA vaccine. This development signifies a significant step forward in the company’s efforts to combat the evolving SARS-CoV-2 virus. Preclinical Study…
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JS InnoPharm Initiates Phase Ib Study of AURKA Inhibitor VIC-1911 for EGFR-TKI Resistant NSCLC
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JS InnoPharm Ltd, a Shanghai-based pharmaceutical company, announced that the first patient has been dosed in a Phase Ib clinical study for its small-molecule aurora A kinase (AURKA) inhibitor, VIC-1911. This trial marks a significant step in the development of the drug, which is being investigated for its potential in…
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AffaMed Therapeutics Gets NMPA Approval for Phase III Dextenza Study in Post-Ophthalmic Surgery
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China-based AffaMed Therapeutics has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III regulatory study. The study will assess the efficacy and safety of Dextenza in subjects following ophthalmic surgery, marking a significant step forward for the company. Dextenza’s Development and…
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Junshi Biosciences’ JS401 Receives NMPA Approval for Hyperlipidemia Clinical Trial
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Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biopharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for JS401, an injectable co-developed with Risen Pharma, for the treatment of hyperlipidemia. JS401’s Mechanism of ActionJS401 is an innovative angiopoietin-like 3 (ANGPTL3)…
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Aosaikang Pharmaceutical Receives NMPA Review for ASKC200 Liniment from Propella Therapeutics
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the National Medical Products Administration (NMPA) has accepted for review its clinical trial approval filing for ASKC200, a liniment product in-licensed from US-based Propella Therapeutics, Inc. The primary indication for the product is the treatment of osteoarthritis pain. Product Rights…
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Chengdu Hyperway Pharmaceuticals’ HBW-004285 Gets NMPA Tacit Approval for Pain Treatment
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China-based Chengdu Hyperway Pharmaceuticals has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its Nav1.8 inhibitor, HBW-004285, which is intended for the treatment of acute and chronic pain. Understanding the Role of Nav1.8 in Pain SignalingNav1.8 is a tetrodotoxin-insensitive voltage-gated sodium ion channel that…
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Sirnaomics Commences Phase I Clinical Trial for Factor Xl RNAi Drug STP122G
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Sirnaomics Ltd (HKG: 2257) has announced the commencement of a single-center, randomized, double-blind, placebo-controlled, sequence grouping Phase I clinical study for its factor Xl-targeted RNAi drug, STP122G. The US-based trial is designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy subjects initially, before expanding to its…
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Zelgen Biopharmaceuticals’ ZG006 Earns FDA Approval for Small-Cell Lung Cancer Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical trial approval from the US FDA for its investigational drug ZG006, intended to treat small-cell lung cancer and other solid tumors. ZG006: A Tri-Specific Antibody Targeting CD3 and DLL3 EpitopesZG006 is a tri-specific antibody developed through the company’s…
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JW Therapeutics’ Carteyva Receives NMPA Approval for Moderate-to-Severe SLE Clinical Trial
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China-based JW Therapeutics (HKG: 2126) has announced receiving tacit clinical trial approval from the National Medical Products Administration (NMPA) for its product Carteyva (relmacabtagene autoleucel injection; relma-cel). The treatment will be assessed for its efficacy in managing moderate-to-severe refractory systemic lupus erythematosus (SLE). Understanding Systemic Lupus Erythematosus (SLE)SLE is a…
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Yiling Pharmaceutical’s XY0206 Advances to Phase III Trial for FLT3-ITD AML
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced its plans to initiate a Phase III clinical study for its Category 1 chemical drug XY0206, which targets recurrent/refractory acute myeloid leukemia (AML) patients with FLT3-ITD mutation (FMS-like tyrosine kinase 3 internal tandem duplication). XY0206: A Promising Multi-Target Tyrosine Kinase InhibitorXY0206…
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MicuRx Pharmaceuticals Initiates Phase III Study for MRX-4 in Diabetic Foot Infection Treatment
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced the initiation of a Phase III clinical study for its novel anti-microbial agent MRX-4, used in combination with contezolid (MRX-I), as a sequential treatment for diabetic foot infection in China. Global Multi-Center Phase III Study Design and ApprovalThe global multi-center, randomized, double-blind Phase…
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TYK Medicines Secures FDA Approval for Next-Generation TKI Clinical Trial
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China-based TYK Medicines, Inc. has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed next-generation tyrosine kinase inhibitor (TKI). This marks a significant step forward in the development of the company’s pipeline, with a separate clinical trial filing for…
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Yantai Dongcheng Pharmaceutical Gets Singapore Regulatory Approval for 177Lu-LNC1004 Phase I Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving the green light from the regulatory body in Singapore to initiate a Phase I clinical study for its radiotherapeutic drug, 177Lu-LNC1004, which targets fibroblast activation protein (FAP) and is under development to treat FAP-positive advanced solid tumors. This…
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Vcanbio Receives CDE Approval for VUM02 Clinical Trial in Idiopathic Pulmonary Fibrosis
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced receiving clinical trial approval from the Center for Drug Evaluation (CDE) for its VUM02 (human umbilical cord-derived mesenchymal stem cells), a Category 1 therapeutic biologic product. The therapy is set to be assessed as a treatment for idiopathic…
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Haisco Pharmaceutical Gets CDE Approval for HSK38008 Prostate Cancer Clinical Study
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for its Category 1 chemical drug, HSK38008 oral preparation, in the treatment of prostate cancer. HSK38008: An Androgen Mutant AR-V7 Oral Degradation AgentHSK38008 is an androgen mutant…
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Yiling Pharmaceutical’s G201-Na Receives CDE Approval for Phase Ia Study in Prostate Cancer Treatment
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China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a single-center, randomized, double-blind, placebo-controlled, dosage escalation Phase Ia study. The study will assess the safety, tolerability, and pharmacokinetics of G201-Na in healthy adult males in China. G201-Na: A Small…
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AffaMed Digital Initiates Clinical Study for AMD201 at Beijing Tiantan Hospital
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AffaMed Digital, a company wholly owned by AffaMed Technologies—a joint venture between AffaMed Therapeutics and SIFI S.p.A.—has announced the first patient enrollment in a clinical study for its AMD201 at the Beijing Tiantan Hospital. This marks a significant step in the development of digital therapies for post-stroke cognitive impairment (PSCI).…
