Hengrui’s Pyrotinib Granted Breakthrough Therapy Designation by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Hengrui Medicine Co., Ltd’s (SHA:...
Breakthrough therapy
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...
Ark Biosciences’ Ziresovir Shows Positive Results in Phase III AIRFLO Study for RSV Infection
China-headquartered Ark Biosciences has announced positive results from the Phase III AIRFLO study for its...
Lepu Biotechnology’s MRG003 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received Breakthrough Therapy...
Lepu Biotechnology’s MRG003 Receives Orphan Drug Designation from FDA
China-based Lepu Biotechnology Co., Ltd (HKG: 2157) has announced that it has received orphan drug...
Keymed and Lepu’s CMG901 Receives Breakthrough Therapy Designation for Gastric Cancer
The Center for Drug Evaluation (CDE) website indicates that CMG901, a Claudin 18.2 (CLDN18.2)-targeted antibody...
Hainan Yuekang’s YK-029A Biosimilar Set for BTD in EGFR ex20ins NSCLC
The Center for Drug Evaluation (CDE) website indicates that China-based Hainan Yuekang Biological Medicine Co.,...
Akeso Bio’s AK112 Wins Breakthrough Designation for First-Line NSCLC
China’s Akeso Bio has secured a breakthrough therapy designation (BTD) from the Center for Drug...
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:...
Belief-Delivery BioMed’s BBM-H901 Granted BTD for Hemophilia B Prevention
The Center for Drug Evaluation (CDE) website indicates that Shanghai Belief-Delivery BioMed Co., Ltd’s injectable...
Neurophth’s NR082 Gene Therapy Receives BTD for Leber Hereditary Optic Neuropathy
China’s Center for Drug Evaluation (CDE) has awarded breakthrough therapy designation (BTD) to Wuhan Neurophth...
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 –...
Kelun Pharma’s SKB264 ADC Receives Breakthrough Therapy Designation for TNBC
The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE:...
InventisBio’s KRAS G12C Inhibitor D-1553 Earns CDE Breakthrough Therapy Status
China-based InventisBio (Shanghai) Co., Ltd announced receiving breakthrough therapy designation (BTD) status for its KRAS...
Zai Lab’s Repotrectinib Earns Two Breakthrough Therapy Designations in China for ROS1+ NSCLC
China-based biopharma Zai Lab Ltd (NASDAQ: ZLAB) announced receiving two breakthrough therapy designations (BTDs) from...