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...
Rare / orphan disease drugs
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...
Hrain Biotech and Novartis Receive Breakthrough Therapy Designations for CAR-T and Zolgensma
The Center for Drug Evaluation (CDE) website indicates that Hrain Biotechnology Co., Ltd’s BCMA –...
NMPA Releases Work Plans for Temporary Import of Urgently Needed Drugs
The National Medical Products Administration (NMPA) has officially released the “Work Plan for the Temporary...
Takeda’s Obizur Prioritized for Review in Acquired Hemophilia A Treatment
The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd’s Obizur (susoctocog...
BDgene Advances CRISPR-Based BD111 for Herpes Keratitis with IND Filing
Shanghai BDgene Technology Co., Ltd has completed efficacy and preliminary safety studies for BD111, its...
Lundbeck Initiates TALISMAN Study on Multiple System Atrophy in China and EU
Danish-based Lundbeck (OTCMKTS: HLUBF) has announced plans to initiate a global investigational study on multiple...
Lee’s Pharmaceutical Wins NMPA Approval for ALS Drug Teglutik
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has announced receiving market approval from the National...
Takeda’s Obizur Accepted by China’s NMPA for Acquired Hemophilia A Treatment
Takeda Pharmaceutical Co., Ltd’s (NYSE: TAK, TYO: 4502) China unit announced that a New Drug...
Quoin Pharmaceuticals Partners with WinHealth for Rare Disease Treatments in Greater China
US-based rare disease specialist Quoin Pharmaceuticals Ltd (NASDAQ: QNRX) announced a licensing and distribution agreement...