Beijing HSA Sets Price for Hainan Simcere’s COVID-19 Therapy SIM0417
Beijing’s municipal Healthcare Security Administration (HSA) bureau has released details of the initial quote and...
Drug
Qilu Pharmaceutical’s Biosimilar Lucentis Accepted for Review by China’s CDE
China-based Qilu Pharmaceutical has announced that its market approval filing for a biosimilar version of...
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...
CARsgen and Roche Partner on Clinical Study for Gastric Cancer Treatment
China-based CAR-T cell specialist CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a clinical cooperation...
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...
Betta Pharmaceuticals’ BPI-D0316 Accepted for Review by CDE for First-Line NSCLC
China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced that another market approval filing for...
Jiangsu Alpha Biopharma’s Zorifertinib NDA Accepted for Review by CDE
China-based Jiangsu Alpha Biopharma Ltd has announced that the New Drug Application (NDA) for its...
Grand Pharma’s Jext Auto-Injector Approved for Import into Greater Bay Area
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced receiving official approval from the Guangdong...
Abbisko’s ABSK021 Receives FDA Breakthrough Therapy Designation for TGCT
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving breakthrough therapy designation (BTD)...
CDE Grants Priority Review Status to Kechow’s HL-085 for Melanoma Treatment
The Center for Drug Evaluation (CDE) website indicates that Kechow Pharma’s HL-085 is set to...
NMPA Approves Two China-Developed COVID-19 Small-Molecule Therapies
The National Medical Products Administration (NMPA) has issued conditional marketing approvals to two novel, China-discovered...
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...
InnoCare’s Gunagratinib Shows Promising Data in Cholangiocarcinoma at ASCO-GI 2023
Beijing InnoCare Pharma Tech Co. (HKG: 9969), a China-based biotech specializing in cancer and autoimmune...
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...
Simcere’s Cosela Receives First Prescription in China for CDK4/6 Inhibition
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the issuance of the first prescription for...
Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer
Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical...
Fosun Pharma’s Comirnaty Bivalent Vaccine Approved in Macau for Booster Shots
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its Comirnaty...
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...