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...
Drug
Joincare’s Biosimilar Tocilizumab Approved for Marketing in China
China-based Joincare Pharmaceutical Industry Group Co., Ltd (SHA: 600380) has announced that its subsidiary Zhuhai...
CANbridge Pharmaceuticals Initiates Phase II Dosing for CAN103 in Gaucher Disease
China-based CANbridge Pharmaceuticals, Inc. (HKG: 1228) has announced the first patient dosing in the Phase...
CDE Grants Priority Review to Takeda’s Vonicog Alfa, Zhongmei’s Rilonacept, and Zai Lab’s SUL-DUR
The Center for Drug Evaluation (CDE) has indicated that Takeda’s Vonicog alfa, Zhongmei Huadong Pharma’s...
Immunofoco’s CLDN18.2-Targeted CAR-T Therapy IMC002 Accepted for CDE Review
China’s Center for Drug Evaluation (CDE) has accepted a clinical trial filing for IMC002, an...
Keymed Biosciences’ CMG901 Shows Promising Results in Phase Ia Study for Solid Tumors
China-based Keymed Biosciences Inc. (HKG: 2162) has revealed the latest data update from a Phase...
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...
Everest Medicines’ EVER206 Shows Positive Phase I Results in China
China-based Everest Medicines (HKG: 1952) has announced top-line results from a Phase I study in...
Junshi Biosciences’ Neotorch Study Achieves Superiority in Lung Cancer Trial
Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its randomized, double-blind, placebo-controlled,...
Hengrui’s EZH2 Inhibitor SHR2554 Nears Breakthrough Therapy Designation
China-based Jiangsu Hengrui Pharmamceuticals (SHA: 600276) has announced that its enhancer for the zeste homolog...
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...
Junshi Biosciences’ COVID-19 Drug JT001 (VV116) Accepted for NMPA Review
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that its oral nucleoside analog drug...
Bristol-Myers Squibb’s Opdivo Gains New Indication for NSCLC Neoadjuvant Therapy in China
US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has secured another indication approval in China...
Daiichi Sankyo’s Mirogabalin Nears China Market Entry with CDE Review
Japan-based Daiichi Sankyo Inc. (TYO: 4568) has announced that China’s Center for Drug Evaluation (CDE)...
Bio-Thera’s Biosimilar BAT1806 Passes NMPA Review, Targets Roche’s Actemra
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that its biosimilar drug BAT1806, modeled after...
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...
CStone’s RET Inhibitor Gavreto Approved in Taiwan for Lung and Thyroid Cancers
CStone Pharmaceuticals (HKG: 2616) has announced receiving marketing approval in Taiwan for its RET inhibitor...
Simcere’s COVID-19 Drug SIM0417 Accepted for Special Review by NMPA
China-based Simcere Pharmaceutical Group (HKG: 2096) has announced that the National Medical Products Administration (NMPA)...
Bristol-Myers Squibb’s Opdivo Secures Two New Approvals for Esophageal Cancer in China
US-based pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY) has received two new indication approvals in...
Henlius’ PD-1 Inhibitor HanSiZhuang Approved for First-Line SCLC Indication
Shanghai Henlius Pharmaceutical Co., Ltd (HKG: 2696) has announced receiving another indication approval from China’s...