Simcere Receives FDA Clearance for Clinical Study of SIM0237
China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US...
Drug
United Labs Gains NMPA Approval for Ozempic Biosimilar IND
Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products...
OriginCell’s CAR-T Therapy Receives FDA Orphan Drug Designation for Multiple Myeloma
Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor...
Ascentage Pharma Files for Phase Ib/II Study of Bcl-2 Inhibitor in Systemic Lupus Erythematosus
Suzhou-based Ascentage Pharma (HKG: 6855) has announced the submission of a clinical filing with the...
Shanghai Henlius’ PD-1 Inhibitor Serplulimab Gains Australian Clearance for Phase III Study
Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving regulatory clearance in Australia to...
Covis Pharma’s COPD Therapies Show Positive Results in Phase III AVANT Trial
Luxembourg-based Covis Pharma Group has released positive topline data from its Phase III AVANT trial,...
CSPC Receives CDE Approval for Generic Version of Pfizer’s Xeljanz
China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received market...
Daiichi Sankyo Initiates Global Phase II Study of DS7300 for Small-Cell Lung Cancer
Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced the first patient dosing in a global...
Abbisko’s ABSK021 Gets CDE Approval for Phase III Study in Giant Cell Tumor of Tendon Sheath
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval...
Livzon Launches National Rollout of COVID-19 Vaccine V-01 in China
China-based Livzon Pharmaceutical Group (HKG: 1513) has announced the national promotion of its recombinant novel...
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...
MicuRx Pharmaceuticals Concludes US Phase I Study for MRX-8
Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals (SHA: 688373) has announced the conclusion of Phase I...
Henlius Biotech’s Hanbeitai Approved for Hepatocellular Carcinoma
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced receiving a fourth indication approval from the...
Antengene’s Xpovio Receives Taiwan FDA Approval for Multiple Indications
China-based biopharma Antengene Corp., Ltd (HKG: 6996) has announced receiving market approval from the Taiwan...
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...
Sinopharm’s Wuhan Institute Isolates Monkeypox Strains, Begins Vaccine Research
China’s Wuhan Institute of Biological Products, a research affiliate of Sinopharm’s China National Biotech Group...
Betta Pharmaceuticals’ BPI-460372 Accepted for Clinical Trial Review by NMPA
China’s Betta Pharmaceuticals (SHE: 300558) has announced that its clinical trial filing for the Category...
Frontier Biotechnologies Secures Approval for HIV Therapy Alfusid
Nanjing-based Frontier Biotechnologies Inc. has announced that its supplementary market filing for Alfusid (albuvirtide), China’s...
Hengrui’s Camrelizumab and Akeso’s AK112 Set to Receive Breakthrough Designation in China
The Center for Drug Evaluation (CDE) website indicates that China-based Jiangsu Hengrui Medicine Co., Ltd’s...
China Approves GSK’s Juluca for HIV-1 Infection
The National Medical Products Administration (NMPA) has approved the market application for GlaxoSmithKline’s (GSK, NYSE:...