Huahai Pharmaceutical Gains FDA Approval for Generic Fingolimod
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New...
Rare / orphan disease drugs
Lepu Biopharma’s MRG002 Earns FDA Orphan Drug Status for Gastric Cancer
China’s Lepu Biopharma Co., Ltd (HKG: 2157) announced that the U.S. FDA has granted orphan...
Staidson and J&J’s Teclistamab Gain Breakthrough Designation for Hemophilia and Myeloma
The Center for Drug Evaluation (CDE) has indicated that Staidson (Beijing) Pharmaceutical Co., Ltd’s (SHE:...
Henlius Biotech’s PD-1 Inhibitor Serplulimab Secures NMPA Review for Esophageal Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) announced that the National Medical Products Administration (NMPA) has...
Lee’s Pharma Expands Global Rights to Windtree’s KL4 Surfactant Products
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has expanded its licensing agreement with US-based Windtree...
CSPC Pharmaceutical’s Mitoxantrone Liposome Approved for NMOSD Clinical Study
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that its mitoxantrone hydrochloride liposome has received...
Spinraza’s NRDL Inclusion Boosts SMA Patient Treatment in China
The Meier Advocacy & Support Center for Spinal Muscular Atrophy (SMA) and the Shenzhen Research...
Grand Pharmaceutical’s Carglumic Acid Set for Priority Review by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Grand Pharmaceutical Group Limited’s (HKG:...
CDE Prioritizes Review for Sanofi’s Nexviazyme and WinHealth’s Ravicti
The Center for Drug Evaluation (CDE) website indicates that two drugs have been selected for...
NMPA Accepts Roche’s Crovalimab Filing for PNH Treatment with Priority Review
The National Medical Products Administration (NMPA) has officially accepted for review the market filing submitted...
Immvira’s Oncolytic Virus MVR-C5252 Receives FDA Orphan Drug Designation for Glioma
Shenzhen-based Immvira Co., Ltd, a biotech company focused on oncolytic viruses, announced that it has...
Convalife Pharmaceuticals Licenses Karus Therapeutics’ CVL237 Globally
Shanghai-based Convalife Pharmaceuticals has entered into a licensing agreement with UK-based Karus Therapeutics Ltd, acquiring...
CSPC Pharmaceutical’s Albumin-Bound Docetaxel Receives Orphan Drug Designation for Gastric Cancer
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received an orphan drug...
Kira Pharmaceuticals’ KP104 Receives Orphan Drug Designation for PNH Treatment
Sino-US biotech Kira Pharmaceuticals announced that it has received an Orphan Drug Designation (ODD) from...
HitGen and LoQus23 Therapeutics Partner on DNA Encoded Library for Neurodegeneration
China-based HitGen Inc. (SHA: 688222) announced a strategic partnership with UK-headquartered LoQus23 Therapeutics Ltd, leveraging...
Junshi Biosciences’ Toripalimab Receives EC Orphan Drug Designation for NPC
China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that its PD-1 inhibitor Toripalimab (trade name:...
CANbridge Pharmaceuticals Doses First Patient in CAN103 Gaucher Disease Trial
China-based rare disease firm CANbridge Pharmaceuticals announced the dosing of the first patient in a...
Luye Pharma’s Lurbinectedin Receives Hainan Approval for SCLC Treatment
China-based Luye Pharma Group (HKG: 2186) announced approval from the Hainan Medical Products Administration for...
Zai Lab’s Efgartigimod NDA Accepted by NMPA for Myasthenia Gravis
Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the National Medical Products Administration (NMPA)...
Abbisko Therapeutics’ ABSK021 Receives BTD for Giant Cell Tumor Treatment
Shanghai-based Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that its Category 1 drug ABSK021 has...