Harbour BioMed’s Anti-CCR8 Monoclonal Antibody HBM1022 Receives FDA IND Approval
Harbour BioMed (HBM), which operates out of the Netherlands, the United States, and Suzhou, China,...
Clinical trial approval / initiation
Antengene Launches Phase I CLINCH Study for ATG-022 in Australia
China-based Antengene Corporation Ltd (HKG: 6996) has received approval from Australia’s Therapeutic Goods Administration (TGA)...
Henlius Begins Phase I Trial for Biosimilar HLX15 Targeting Multiple Myeloma
Shanghai Henlius Biotech (HKG: 2696) has announced the dosing of the first subject in a...
Hengrui’s Lutetium [177Lu] Oxy-Octreotide Gains Clinical Clearance in China
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical clearance from the National Medical...
Ascletis Receives FDA Approval for Phase IIa Trial of ASC10 in RSV Infection
China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving approval from the US FDA to...
Betta Pharmaceuticals Gains FDA Approval for Clinical Trial of BPI-460372
China’s Betta Pharmaceuticals (SHE: 300558) has announced receiving clinical trial approval from the US FDA...
RemeGen’s Telitacicept Gains FDA Approval for Phase III Study in Myasthenia Gravis
China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has announced receiving approval from the US...
Luye Pharma Gains CDE Approval for Goserelin Acetate Microspheres Clinical Study
China-based Luye Pharma Group (HKG: 2186) has announced receiving approval from the Center for Drug...
Haisco’s Prostate Cancer Drug HSK38008 and DPP-4 Inhibitor HSK7653 Accepted for Review
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the clinical trial filing for...
HealZen Therapeutics Gains NMPA Approval for HZ-A-018 Clinical Study in Autoimmune Diseases
Hangzhou-based HealZen Therapeutics has announced receiving approval from the National Medical Products Administration (NMPA) to...
JS InnoPharm’s US Subsidiary Initiates Phase I Trial for AURKA Inhibitor VIC-1911
Shanghai-based JS InnoPharm Ltd has announced the initiation of a Phase I clinical study by...
Exegenesis Bio Gains FDA Approval for Gene Therapy EXG102-031 in Wet AMD
Hangzhou-based clinical stage gene therapy firm Exegenesis Bio has announced receiving approval from the US...
HuidaGene Receives FDA IND Approval for Ophthalmology Gene Therapy HG004
China-based HuidaGene (Shanghai) Biotechnology Co., Ltd has announced receiving Investigational New Drug (IND) approval from...
Ascletis Receives IND Approval for ASC10 in Monkeypox Treatment
China-based Ascletis Pharma Inc. (HKG: 1672) has announced receiving Investigational New Drug (IND) approval from...
CSPC’s Octreotide Long-Acting Injection Approved for Acromegaly Clinical Study
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical...
CNBG-Virogin’s Omicron-Targeted mRNA Vaccine Approved for Clinical Trials
CNBG-Virogin Biotech (Shanghai) Co., Ltd has announced obtaining clinical trial approval from the National Medical...
Harbour BioMed Receives FDA Approval for HBM1007 Clinical Study
China-based Harbour BioMed (HKG: 2142) has announced receiving approval from the US FDA to initiate...
Staidson’s STSP-0601 Begins Phase II Study for Hemophilia Treatment
China-based Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204) has announced the first subject dosing in...
Hansoh’s HS-10517 Greenlit for COVID-19 Clinical Study by NMPA
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced receiving approval from the National...
Abbisko’s ABSK021 Gains NMPA Approval for Phase II Study in cGVHD
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving approval from the National...