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Shanghai Henlius Biotech Initiates Patient Dosing in Global Phase III ELAINE-3 Study for Lasofoxifene
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the first Chinese patient dosing in the global, multi-center Phase III ELAINE-3 study for its investigational drug lasofoxifene. The study focuses on pre/post menopausal women and men with estrogen receptor positive (ER+), human epidermal growth…
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Alphamab Oncology’s JSKN033 Gets Green Light for Phase I/II Study from China’s CDE
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China-based Alphamab Oncology (HKG: 9966) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with a Phase I/II study for its investigational drug, JSKN033. Design and Objectives of the Upcoming Phase I/II StudyThe imminent open, multi-center…
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CSPC Pharmaceutical’s SYH2062 Receives NMPA Clearance for Hypertension Treatment
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received clinical clearance from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug, SYH2062. SYH2062: A Novel siRNA Therapy for HypertensionSYH2062 is an N-acetyl-galactosamine (GalNAc)-conjugated small interfering RNA (siRNA) that targets the inhibition of…
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Sichuan Biokin’s GNC-038 Tetra-Specific Antibody Clears for Clinical Trials in Autoimmune Diseases
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to proceed with clinical trials for its innovative tetra-specific antibody, GNC-038. The trials will focus on the treatment of systemic lupus erythematosus and rheumatoid arthritis.…
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Changchun High & New Technology Industries Receives FDA Approval for Menopausal VMS Drug Trial
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China-based Changchun High & New Technology Industries (Group) Inc., (SHE: 000661) has received the green light from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its Category 1 chemical drug, GS1-144, in treating menopausal vasomotor symptoms (VMS). Understanding Menopausal Vasomotor Symptoms and the…
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ETERN Therapeutics’ YAP/TEAD Inhibitor ETS-006 Wins FDA Clinical Approval for Advanced Solid Tumors
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China-based biopharmaceutical company ETERN Therapeutics has announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its YAP/TEAD inhibitor, ETS-006, which targets multiple advanced solid tumors. ETS-006: A Promising Oral YAP/TEAD PPI InhibitorETS-006 is an oral YAP/TEAD protein-protein interaction (PPI) inhibitor that has shown…
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Changchun BCHT Biotechnology Receives NMPA Approval for HSV-2 mRNA Vaccine LVRNA101
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Changchun BCHT Biotechnology Co., Ltd (SHA: 688276), a China-based biotechnology company, has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its mRNA vaccine, LVRNA101. The vaccine is designed to prevent genital herpes caused by herpes simplex virus type 2 (HSV-2) infection. HSV-2 and the Need…
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Shenzhen Chipscreen Biosciences Gets NMPA Approval for CS231295 Solid Tumor Study
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a China-based biopharmaceutical company, has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate CS231295 in advanced solid tumors. CS231295: A Promising Multi-Target InhibitorCS231295 is a multi-target protein kinase inhibitor that has…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval to Test SHR-1681 in Clinical Trials
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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 proceed with clinical testing of its Category 1 biologic product, SHR-1681. Novel Biologic Product SHR-1681The product, SHR-1681, is designed to specifically bind to antigens present on the surface…
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CSPC Pharmaceutical Group Receives NMPA Approval for Two Antibody-Drug Conjugates
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SYS6005 and SYS6043. Pre-Clinical Success and Potential ApplicationsBoth SYS6005 and SYS6043, classified as Category 1 biologic products with undisclosed…
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CanSino Biologics Initiates Phase I/II Study for CS-2036 Polio Vaccine with Gates Foundation Support
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CanSino Biologics (SHA: 688185, HKG: 6185) has announced the initiation of a Phase I/II study for its CS-2036, a recombinant polio vaccine, in Indonesia with financial support from the Bill & Melinda Gates Foundation. This development is accompanied by the first subject enrollment in the Phase I trial. Additionally, the…
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Joincare Pharmaceutical’s JKN2403 Gains NMPA Approval for COPD Clinical Trials
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China-based Jo2006incare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) is set to advance its Category 1 chemical drug, JKN2403, into clinical trials for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD), following approval from the National Medical Products Administration (NMPA). JKN2403: A Novel COPD Treatment with Promising…
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AIM Vaccine Co., Ltd Receives NMPA Clearance for Innovative Cell-Based Influenza Vaccine
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AIM Vaccine Co., Ltd (HKG: 6660), a China-based biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its suspension cultured quadrivalent MDCK cell influenza vaccine. This marks a significant step forward in the development of a novel…
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AIM Vaccine Co., Ltd Receives NMPA Approval for Second-Gen Tetanus Vaccine Clinical Trial
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its second-generation high-valent adsorbed tetanus vaccine. This development is a significant step forward in the company’s efforts to combat a disease that is both serious and…
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Chengdu Kanghua Biological Receives NMPA Approval for Recombinant Norovirus Vaccine
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Chengdu Kanghua Biological Products Co., Ltd, (SHE: 300841), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its recombinant hexavalent norovirus vaccine (Pichia pastoris). The vaccine is designed to prevent acute gastroenteritis caused by genotype…
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Huadong Medicine’s HDM1005 Receives FDA Clearance for Heart Failure and Obesity Clinical Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, HDM1005. The drug will now proceed to clinical trials involving patients with heart failure with preserved ejection fraction (HFpEF) and obesity. HDM1005:…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1501 Combo in Bladder Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for the combination of SHR-1501 with adebrelimab (SHR-1316) for the treatment of non-muscle invasive bladder cancer. Adebrelimab: A PD-L1 Monoclonal Antibody with…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Amulirafusp Alfa in NMOSD
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced the commencement of a Phase Ib study for its innovative dual-target macromolecular drug, amulirafusp alfa (IMM0306), in patients with neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step as the first patient has been dosed in the…
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Vcanbio’s VUM02 Secures NMPA Approval and FDA ODD for Cirrhosis and aGvHD
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China-based Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced significant progress for its in-house developed VUM02 for injection, receiving approval from the National Medical Products Administration (NMPA) in China to study the treatment of decompensated cirrhosis and obtaining Orphan Drug Designation (ODD) from the Food and Drug…
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Abbisko Therapeutics Receives NMPA Approval for Irpagratinib Regulatory Study
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to initiate a regulatory study for its novel small-molecule FGFR4 inhibitor, irpagratinib. Details of the Approved TrialThe approved trial, ABSK-011-205, is…
