SineuGene Therapeutics’ SNUG01 Receives FDA Clearance for ALS Clinical Study
Beijing-based SineuGene Therapeutics, a developer of gene therapies for brain disorders, announced last week that...
Drug
GSK’s Nucala Accepted for EMA Review for COPD Treatment
UK-based GSK plc’s (LON: GSK, NYSE: GSK) application for expanding the use of its anti-interleukin-15...
Shanghai Ark Biopharmaceutical’s AK0901 Meets Phase III Endpoints in ADHD Trial
China’s Shanghai Ark Biopharmaceutical Co., Ltd. has announced the completion of a Phase III study...
Suzhou Xueji Biotech’s XJ-MK-002 Gets FDA Orphan Drug Designation for CAMT
China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd’s (HemaCell) XJ-MK-002, described as the world’s...
Beijing Sungen Biomedical’s SGC001 Receives FDA Fast Track Designation for AMI Treatment
China-based Beijing Sungen Biomedical Technology Co., Ltd, an antibody developer incubated by Hotgen Biotech Co.,...
AllianThera Biopharma Starts Global Phase I Trial for ATB102 in Inflammatory Bowel Diseases
Suzhou-based startup AllianThera Biopharma has announced the first patient dosing in a global Phase I...
Jiangsu Hengrui Pharmaceuticals’ Ivarmacitinib Receives NMPA Approval for Ankylosing Spondylitis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving marketing approval from the National...
Kexing Biopharm Partners with BioMap on AI-Driven Macromolecular Drug Development
China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced a partnership with US biotech firm BioMap...
CStone Pharmaceuticals Files for EMA Approval of Sugemalimab for Unresectable Stage III NSCLC
China-based CStone Pharmaceuticals (HKG: 2616) has announced filing for another indication approval for its anti-programmed...
Clover Biopharmaceuticals Receives FDA Approval for SCB-1019 RSV Vaccine Trial
China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced receiving clinical approval from the US Food...
AIM Vaccine’s mRNA-based Shingles Vaccine Receives FDA Approval for Clinical Study
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the US Food...
FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL)...
Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the...
HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National...
Innovent Biologics Doses First Patient with IBI354 in HeriCare-Ovarian01 Study
China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate...
Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for...
CSPC Pharmaceutical Group Gains NMPA Approval for SYS6040 Clinical Trial
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical...
Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan....
Triastek’s 3D-Printed T20G Receives US Clinical Approval for NOAC Treatment
China-based Triastek Inc., a pharmaceutical-focused 3D printing company, has announced receiving clinical approval in the...
Johnson & Johnson’s Tremfya Gains FDA Approval for Crohn’s Disease Treatment
US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the...