Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary...
Breakthrough therapy
JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva...
AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the...
Brii Biosciences’ BRII-179 Vaccine on Track for Breakthrough Therapy Designation in China
China’s Center for Drug Evaluation (CDE) website has indicated that Brii Biosciences Ltd (HKG: 2137),...
CSPC Pharmaceutical’s Glumetinib Earns Breakthrough Therapy Designation in China
Glumetinib, a MET targeted tyrosine kinase inhibitor (TKI) co-developed by CSPC Pharmaceutical Group Ltd (HKG:...
I-Mab and HI-Bio’s Felzartamab Earns Breakthrough Therapy Designation from US FDA
China-based I-Mab (NASDAQ: IMAB) and its US partner HI-Bio have announced that they have received...
Chongqing Precision Biotechnology’s PCAR-19B Receives CDE Nod for Breakthrough Therapy Designation
The China’s Center for Drug Evaluation (CDE) website has indicated that Chongqing Precision Biotechnology Co.,...
Allist Pharmaceuticals’ Furmonertinib Receives FDA Breakthrough Therapy Designation for NSCLC
Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough...
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)...
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...