CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG)...
Breakthrough therapy
AcornMed Receives FDA Breakthrough Device Designation for Urothelial Carcinoma Liquid Biopsy
Beijing-based tumor precision medicine specialist, AcornMed, has been granted Breakthrough Device Designation (BDD) by the...
CDE Indicates BTD Status for Visirna’s VSA001, Sperogenix’s Vamorolone, and Zai Lab’s Efgartigimod
The Center for Drug Evaluation (CDE) website has indicated that Visirna Therapeutics’ novel siRNA therapy...
Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for CDE’s BTD Status
China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its HER2 targeted antibody-drug...
AstraZeneca and Daiichi Sankyo’s Enhertu Earns Two BTDs for HER2+ Malignancies
The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi...
ImmunoTech Biopharm’s EAL Earns Breakthrough Therapy Designation for HCC Recurrence Prevention
The Center for Drug Evaluation (CDE) in China has indicated on its website that Immunotech...
Zai Lab’s Repotrectinib Targets Breakthrough Therapy Designation for TRK-Positive Tumors
The Center for Drug Evaluation (CDE) website has indicated that repotrectinib, a next-generation ROS1/TRK/ALK tyrosine...
HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Gastric Cancer
HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its MET inhibitor, Orpathys (savolitinib),...
Mirxes Holding Company Receives FDA Breakthrough Device Designation for GASTROClea
Singapore-based RNA technology company, Mirxes Holding Company Ltd, which specializes in blood-based miRNA test kit...
Suzhou Jiecheng Medical Secures FDA BDD for Transvascular Aortic Valve Treatment
Suzhou Jiecheng Medical Technology Co., Ltd has announced that it has obtained Breakthrough Devices Designation...
Jacobio Pharma’s Glecirasib Enters Breakthrough Therapy Review for Pancreatic Cancer Treatment
China-based Jacobio Pharma (HKG: 1167) has announced that its novel KRAS G12C inhibitor, glecirasib, has...
Eli Lilly’s Mirikizumab and Chia Tai Tianqing’s Lanifibranor Enter Breakthrough Therapy Review
US pharmaceutical major Eli Lilly’s (NYSE: LLY) mirikizumab and China-based Chia Tai Tianqing’s lanifibranor have...
HutchMed’s Elunate-Tyvyt Combo Receives Breakthrough Therapy Designation in China for Endometrial Cancer
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the combination of Elunate (fruquintinib)...
TransThera Sciences’ TT-00420 Receives Breakthrough Designation for Cholangiocarcinoma Treatment
The Center for Drug Evaluation (CDE) website has indicated that Nanjing-based TransThera Sciences (Nanjing), Inc.’s...
Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co.,...
CDE Considers Breakthrough Therapy Designation for Beijing Mabworks’ MIL162 and Amgen’s AMG 890
The Center for Drug Evaluation (CDE) website indicates that China-based Beijing Mabworks Biotech Co., Ltd’s...
Ascentage Pharma’s Olverembatinib Earns Breakthrough Designation for SDH-Deficient GIST
The China’s Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) to olverembatinib,...
Huadong Medicine’s Mefatinib Poised for Breakthrough Therapy Designation by CDE
The Center for Drug Evaluation (CDE) website indicates that China-based Huadong Medicine Co., Ltd (SHE:...
Innovent Biologics’ GFH925 Earns Breakthrough Therapy Designation for KRASG12C CRC Treatment
The Center for Drug Evaluation (CDE) website indicates that China-based Innovent Biologics’ (HKG: 1801) Category...
Fosun Pharmaceutical’s FCN-159 Earns Breakthrough Therapy Designation for Histiocyte Tumors
The Center for Drug Evaluation (CDE) website has announced that Shanghai Fosun Pharmaceutical (Group) Co.,...