Hengrui Medicine Gains Approval for Phase Ib/II Study of SHR-A1811 and SHR-1701 in HER2-Positive Gastric Cancer
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval to initiate a...
Clinical trial approval / initiation
AIM Vaccine Receives CDE Approval for Serum-Free Rabies Vaccine Trial
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving clinical trial approval from the...
Zhiyi Biotechnology Receives FDA Clearance for SK10 in Chemotherapy-Induced Diarrhea
Guangzhou-based Zhiyi Biotechnology has announced receiving clearance from the US FDA for a clinical study...
Abogen Biosciences Receives UAE Clinical Trial Approval for Omicron BA.4/5 mRNA Vaccine
China’s Abogen Biosciences Co., Ltd, a developer of messenger ribonucleic acid (mRNA) drugs, has announced...
Gracell Biotechnologies Initiates Phase II Dosing for GC007g in B-ALL Patients
China-based Gracell Biotechnologies Inc. has announced the first patient dosing in the Phase II portion...
Henlius Biotech Gains NMPA Approval for Phase I Trial of HLX60 in Solid Tumors and Lymphomas
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving approval from the National Medical Products...
Grand Pharma’s TLX591-CDx Approved for Prostate Cancer Diagnosis in China
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Investigational New Drug (IND)...
Genor Biopharma Initiates First Patient Dosing for GB263T in China
China’s Genor Biopharma Co., Ltd (HKG: 6998) has announced the first patient dosing in a...
Akeso Biopharma Gains NMPA Approval for AK112 and AK119 Clinical Study
China-based Akeso Biopharma (HKG: 9926) has announced receiving approval from the National Medical Products Administration...
Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA)...
NMPA Approves IND Filing for Henan Genuine Biotech’s Long-Acting HIV Drug CL-197
China-based Henan Genuine Biotech Co., Ltd’s investigational new drug (IND) filing for its oral long-acting...
Simcere Completes Enrollment for Phase III Study of CDK4/6 Inhibitor in mTNBC
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the completion of first-line enrollment for its...
Fujian Cosunter Doses First Patient in Phase I Study of COVID-19 Drug GST-HG171
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that the first patient has...
Ascletis Pharma Doses First Patient in Phase II Study of ASC41 for NASH
Ascletis Pharma Inc. (HKG: 1672), a China-based biopharmaceutical company, has announced that the first patient...
Transcenta’s TST004 Receives FDA IND Clearance for IgAN Treatment
China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received Investigational New Drug...
Kira Pharmaceuticals Gets FDA Green Light for Phase II Study of KP104 in SLE-TMA
Kira Pharmaceuticals, a Sino-US biotech company, has announced that it has received approval from the...
Staidson’s STSP-0601 Receives Clinical Trial Approval for Hemophilia Treatment
Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it...
Henlius Biotech Gets FDA Nod for HLX07 Clinical Study in CSCC
Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US...
Neurophth Biotechnology Doses First Patient in Phase III Trial for NR082
China-based gene therapy specialist Neurophth Biotechnology Ltd has announced that the first patient has been...
Bio-Thera Solutions Completes Phase I Study for COVID-19 Antibody BAT2022
Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced the completion of all dosage groups (from 100...