CF PharmTech’s Inhaled siRNA Therapy ICF004 Receives NMPA Clinical Approval for Interstitial Lung Disease
CF PharmTech Inc. (HKG: 2652) announced that China’s National Medical Products Administration (NMPA) has granted...
Clinical trial approval / initiation
Chengdu Kanghua Initiates Phase II Trial for RSV mRNA Vaccine Through NanoRibo Acquisition in China’s Untapped Market
Chengdu Kanghua Biological Products Co., Ltd. (SHE: 300841) announced the initiation of a Phase II...
Salvectors Receives NMPA Clinical Approval for YB1-X7, World’s First Oncolytic Salmonella Therapy for Advanced Solid Tumors
Salvectors, a China-based oncolytic bacteria therapy developer, announced it has received tacit clinical approval from...
Henlius Biotech Initiates China Dosing in Phase II/III Trial of Novel PD-L1 ADC HLX43 for Squamous NSCLC
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing in China for an...
Hengrui Pharmaceuticals Receives NMPA Approval to Study SHR-1819 in Pediatric Atopic Dermatitis, Challenging Sanofi’s Dupilumab
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received approval from...
Antengene Receives NMPA Approval for Phase III CLINCH-3 Trial of ATG-022 – CLDN18.2-Targeted ADC Advances in Gastric Cancer with Multi-Region Clinical Strategy
Antengene Corporation Limited (HKG: 6996) announced that China’s National Medical Products Administration (NMPA) has granted...
Changchun High & New Technology Industries Subsidiary Secures NMPA Approval for GenSci144, Novel Oral PKU Treatment Targeting SLC6A19 Transporter
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary Changchun...
Hengrui Pharmaceuticals Secures NMPA Clinical Approvals for Two Novel Anti-Tumor Drug Candidates SHR-5421 and HRS-1635
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received separate clinical...
Shanghai Henlius Biotech Initiates Phase II/III Study of Pimurutamab (HLX07) Combination Therapy in First-Line Advanced Squamous NSCLC
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the dosing of the first patient in a...
Shanghai Henlius Biotech Doses First Patient in China for Global Phase I Study of Daratumumab Biosimilar HLX15-SC in Multiple Myeloma
Shanghai Henlius Biotech Inc. (HKG: 2696) announced the dosing of the first patient in China...
China Medical System Secures NMPA Approval for CMS-D001 TYK2 Inhibitor in Ulcerative Colitis and Crohn’s Disease
China Medical System Holdings Limited (CMS, HKG: 0867) announced it has received clinical trial authorization...
OTR Therapeutics Secures NMPA Approval for Phase Ib/II Trial of OTR-8100 – Best-in-Class Small Molecule Inhibitor for Malignant Tumors
OTR Therapeutics announced that China’s National Medical Products Administration (NMPA) has granted approval to initiate...
Shanghai Henlius Biotech Secures Australian TGA Approval for Phase I Trial of HLX3902 Trispecific T-Cell Engager in Prostate Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that Australia’s Therapeutic Goods Administration (TGA) has granted...
Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX48 Bispecific ADC in Advanced Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Lupeng Pharma Enrolls First Patient in Global Phase 3 ROCKET-CLL Trial of Fourth-Gen BTK Inhibitor Rocbrutinib vs. Pirtobrutinib
Lupeng Pharmaceutical Ltd. announced the enrollment of the first patient in its global Phase 3...
Merck KGaA Launches Phase III PROCEADE-CRC-03 Trial for First-in-Class CEACAM5 ADC Precemtabart Tocentecan in Metastatic Colorectal Cancer
Merck KGaA (ETR: MRK) announced the initiation of the Phase III PROCEADE-CRC-03 study, evaluating the...
United Laboratories Secures NMPA Tacit Approval for TUL108 Clinical Study in China Following US Trial Authorization
United Laboratories International Holdings Ltd (HKG: 3933) announced today it has received tacit approval from...
ImmuneOnco Doses First Patient in Phase II Trial of IMM0306 for Systemic Lupus Erythematosus
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (HKG: 1541) announced today the dosing of the first patient...
Leads Biolabs’ Opamtistomig Becomes World’s First 4-1BB Bispecific Antibody to Enter Pivotal Phase III for EP-NEC
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced it has received regulatory clearance in China...
CSPC Pharmaceutical Receives NMPA Clinical Trial Approval for SYH2095, World’s First KAT6 Inhibitor
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received clinical trial approval from China’s...