Mabwell Bioscience Secures NMPA Approval for 9MW5211 Clinical Trial in Multiple Sclerosis – Expanding Autoimmune Pipeline
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that China’s National Medical Products Administration (NMPA)...
Clinical trial approval / initiation
Mabwell Secures NMPA Clinical Trial Approval for 6MW5311 Bispecific Antibody – Dual US-China Authorization for Hematological Malignancies
Mabwell Bioscience Co., Ltd. (HKG: 2493) announced that China’s National Medical Products Administration (NMPA) has...
Ab&B Bio-Tech Secures NMPA Clinical Trial Approval for mRNA Mpox Vaccine – First Dual-Approved Candidate Globally
Ab&B Bio-Tech Co., Ltd. (HKG: 2627) announced that China’s National Medical Products Administration (NMPA) has...
Innovent Biologics Doses First Patient in Pivotal Phase III Trial for IBI3003 Trispecific Antibody in Relapsed/Refractory Multiple Myeloma
Innovent Biologics (HKG: 1801) announced the first subject dosing in the pivotal Phase III TriadicMM-1...
CureGene Pharmaceutical Initiates Pivotal US Clinical Trial for Evategrel, World’s First Dual-Formulation P2Y12 Inhibitor Addressing Clopidogrel Resistance
Shanghai CureGene Pharmaceutical Co., Ltd. announced the enrollment of the first patient in a pivotal...
CSPC Pharmaceutical Secures FDA Clearance for SYHX2008 Octreotide Biosimilar Clinical Trials in US Market
CSPC Pharmaceutical Group (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA) has...
Hotgen Biotech Secures NMPA Approval for SGT003 Bispecific Antibody Targeting Tumor Microenvironment
Hotgen Biotech Co., Ltd (SHA: 688068) announced that China’s National Medical Products Administration (NMPA) has...
Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX3902 Trispecific Antibody in Advanced Solid Tumors
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Hopstem Biotechnology Secures FDA Clearance for hNPC01 Neural Progenitor Cell Therapy in Hemorrhagic Stroke Motor Dysfunction
Hopstem Biotechnology Co., Ltd., a neural stem cell specialist founded by neuroscientists and stem-cell biologists...
Insilico Medicine’s NLRP3 Inhibitor ISM8969 Achieves First-in-Human Milestone in Phase I Trial for CNS Disorders
Insilico Medicine (HKG: 3696) announced that ISM8969, jointly developed with Hygtia Therapeutics Co., Ltd., has...
Hengrui Pharmaceuticals Receives NMPA Clinical Approvals for Two Novel Anti-Tumor Candidates SHR-6914 and HRS-7525, Addressing Unmet Needs in Prostate Cancer and Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received separate clinical...
Shanghai Henlius Biotech Receives Australian Clearance for Phase II Study of PD-L1 ADC HLX43 Combined with Hansizhuang in NSCLC Neoadjuvant Therapy
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received regulatory clearance in Australia to...
Shanghai Leadingtac Secures NMPA Approval for LT-010391 – China’s First Clinical-Stage Oral KRAS-G12D Degrader
Shanghai Leadingtac Pharmaceutical Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has granted...
Simcere Pharmaceutical Secures NMPA Approval for SIM0689 Bispecific Antibody Targeting PD-1 and VEGF in Solid Tumors
Simcere Pharmaceutical Group (HKG: 2096) announced that SIM0689, a novel bispecific antibody (BsAb) targeting both...
Mabwell Bioscience Secures FDA Approval for 6MW5311 Bispecific Antibody Trial in Hematologic Malignancies
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062) announced that the U.S. Food and Drug Administration...
Yipinhong Pharmacy Receives NMPA Clearance for APH03571 Dual-Mechanism Therapy in FLT3-Mutated Relapsed/Refractory AML
Yipinhong Pharmacy Co., Ltd. (SHE: 300723) announced it has received Investigational New Drug (IND) clearance...
Imviva Biotech Receives FDA Clearance for Phase 1b Basket Trial of CTA313 Allogeneic CAR-T Therapy in B Cell-Mediated Autoimmune Diseases
Imviva Biotech announced it has received Investigational New Drug (IND) clearance from the U.S. Food...
Harbour BioMed’s TSLP Inhibitor HBM9378/WIN378 Doses First Patient in Phase II COPD Study with Windward Bio, Supporting Twice-Yearly Dosing Regimen
Harbour BioMed (HKG: 2142) announced that the first patient has been dosed in the Phase...
Hengrui Pharmaceuticals Advances Triple-Asset Breast Cancer Strategy with NMPA Approval for HRS-6209 Combination Study, Leveraging Selective CDK4 Inhibitor and Novel SERD
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced it has received regulatory clearance...
Lynk Pharmaceuticals and Formation Bio Dose First Patient in Phase I BLKR201 Study for CNS-Penetrant TYK201 Inhibitor, Backed by $605M Partnership
Lynk Pharmaceuticals Co., Ltd. and its U.S. partner Formation Bio announced the dosing of the...