Henlius Biotech Receives FDA Clearance for Phase I Trial of HLX05-N Cetuximab Biosimilar in Metastatic Colorectal Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) announced it has received Investigational New Drug (IND) clearance...
Clinical trial approval / initiation
Hengrui Pharmaceuticals Secures NMPA Clinical Approval for KRAS G12D Inhibitor HRS-6093 and Multiple Combination Regimens in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced it has received clinical trial...
Ab&B Bio-Tech Secures NMPA Clinical Approval for mRNA RSV Vaccine, Addressing Critical Unmet Need in China
Ab&B Bio-Tech Co., Ltd. (HKG: 2627) announced it has received clinical trial approval from China’s...
Mabwell Bioscience Secures FDA Clearance for 9MW5211 in IBD, Advances Multi-Indication Autoimmune Pipeline
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062, HKG: 2493) announced it has received clinical clearance...
Harbour BioMed Receives FDA Clearance for Phase I Trial of Novel B7H4xCD3 Bispecific Antibody HBM7004
Harbour BioMed (HKG: 2142) announced it has received clearance from the U.S. Food and Drug...
Joincare Pharma Secures NMPA Clinical Trial Approval for JKN2501 – China’s First Broad-Spectrum β-Lactamase Inhibitor for Drug-Resistant Pneumonia
Joincare Pharmaceutical Group Industry Co., Ltd. (SHA: 600380) announced that China’s National Medical Products Administration...
Simcere Pharmaceutical Receives NMPA Clinical Trial Approval for LRRC15-Targeting ADC SIM0613, Backed by $1.06B Ipsen Global Licensing Deal
Simcere Pharmaceutical Group Limited (HKG: 2096) announced it has received clinical trial approval from China’s...
Senhwa Biosciences Launches Global Phase I/II Trial of First-in-Class Pidnarulex Combined with BeOne’s Tislelizumab in Solid Tumors Including Pancreatic Cancer
Senhwa Biosciences, Inc. (TPE: 6492) announced on May 5, 2026, the initiation of a global,...
Changchun High & New Tech’s GenSci161 Bispecific Antibody Receives NMPA Approval for Non-Infectious Uveitis Trial
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its GenSci161 has...
Insilico Medicine Secures Chinese Clinical Clearance for AI-Discovered Rentosertib Inhalation in Pulmonary Fibrosis
Insilico Medicine (HKG: 3696), a generative artificial intelligence (AI)-driven biotechnology company, announced it has received...
GluBio Pharmaceutical Advances GLB-002 Molecular Glue Degrader to Phase II for Relapsed Follicular Lymphoma
GluBio Pharmaceutical Co., Ltd., a molecular glue targeted protein degradation (TPD) specialist based in Zhejiang,...
Jecho Biopharmaceuticals Secures FDA Clearance for JLM019 Clinical Study in Advanced Malignant Tumors – Novel Bispecific Fc Fusion Protein Targets “Cold Tumors”
Jecho Biopharmaceuticals Co., Ltd., a China-based joint venture between U.S.-based Jecho Laboratories, Inc. and France-headquartered...
BeBetter Medicine Secures FDA Clearance for BEBT-701 Clinical Study – First-in-Class Dual-Target Therapy for Hypertension and High LDL-C
Guangzhou BeBetter Medicine Technology Co., Ltd. (SHA: 688759) announced it has received approval from the...
CSPC Pharmaceutical Receives FDA Clearance to Launch First-in-Class KAT6 Inhibitor SYH2095 Clinical Trial for Advanced Cancers
CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that the U.S. Food and Drug Administration (FDA)...
Kangtai Biological Initiates Phase I Clinical Study for Trivalent Influenza Split Vaccine Produced in MDCK Cells
Shenzhen Kangtai Biological Products Co., Ltd. (SHE: 300601) has announced the initiation of a single-center,...
Gan & Lee’s Nectin-4 ADC GLR1059 Clears Regulatory Hurdle for Solid Tumor Trials
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced it has received approval from China’s...
Leads Biolabs Enrolls First Patient in Phase II Trial for Gastric Cancer Drug Opamtistomig
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced the first patient enrollment in a Phase...
Hengrui Launches Pediatric Trial of Dual GIPR/GLP-1R Agonist HRS9531 in Overweight and Obese Adolescents Following NMPA Clearance
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) has received approval from China’s National...
Shanghai Leadingtac Secures FDA Clearance for Phase I Trial of LT-010391, First Oral KRAS-G12D Degrader in Clinical Development
Shanghai Leadingtac Pharmaceutical Co., Ltd. announced it has received U.S. Food and Drug Administration (FDA)...
Kanghong Pharmaceutical Receives FDA Clearance for KHN921 Gene Therapy Trial in MYBPC3-Associated Hypertrophic Cardiomyopathy – Precision AAV Vector Targets Myocardial Tissue
Chengdu Kanghong Pharmaceutical Group Co., Ltd. (SHE: 002773) announced it has received Investigational New Drug...