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 –...
Rare / orphan disease drugs
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...
Jiangsu Hengrui Medicine’s Hetrombopag Olamine Receives FDA Orphan Drug Designation for ITP
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received orphan...
Zai Lab Ltd Makes FcRn Antagonist Efgartigimod Available for Myasthenia Gravis Treatment
Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the availability of efgartigimod, the world’s...
NHSA Releases Draft Proposals for NRDL Annual Renewal Process
The National Healthcare Security Administration (NHSA) has formulated and released draft proposals for rules covering...
CANbridge Pharmaceuticals Presents Positive Phase I Data for CAN106 at EHA Congress
China-based rare disease firm CANbridge Pharmaceuticals Inc. (HKG: 1228) released the latest data from a...