Avistone’s Vebreltinib and PLB1004 Receive CDE Breakthrough Therapy Designation for NSCLC
China’s Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) to Beijing Avistone...
Breakthrough therapy
HighLife SAS’s TMVR System Receives FDA Breakthrough Device Designation
Medical device firm HighLife SAS, the French partner of China-based Peijia Medical Limited (HKG: 9996),...
Innovent Biologics’ IBI363 Granted Breakthrough Therapy Designation for Melanoma
China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD)...
Hengrui’s HRS-5965 Granted Breakthrough Therapy Designation for IgA Nephropathy
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received breakthrough therapy...
Oriomics’ Liver Cancer Screening Reagent Earns FDA Breakthrough Device Designation
Hangzhou-based Oriomics, a cancer screening specialist backed by Hotgen Biotech Co., Ltd (SHA: 688068), has...
Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an...
Alphamab Oncology’s JSKN033 Receives Breakthrough Therapy Designation for Platinum Resistant Ovarian Cancer
China-based Alphamab Oncology (HKG: 9966) announced receiving Breakthrough Therapy Designation (BTD) from the National Medical...
Ascentage Pharma’s Olverembatinib Receives Third BTD in China for Ph+ ALL Treatment
China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of...
CARsgen’s CT041 Awarded Breakthrough Therapy Designation for Gastric Cancer
CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that its chimeric antigen receptor (CAR) T-cell therapy,...
CSPC Pharmaceutical’s Sirolimus Receives BTD for Malignant PEComa Treatment
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received Breakthrough Therapy Designation...
MediLink’s YL201 Receives Breakthrough Therapy Designation for Nasopharyngeal Carcinoma
Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced receiving another breakthrough therapy designation (BTD)...
Innovent’s IBI343 Receives Breakthrough Therapy Designation for Pancreatic Cancer
China-based biopharma Innovent Biologics, Inc. (HKG: 1801) has announced receiving another Breakthrough Therapy Designation (BTD)...
JW Therapeutics’ Carteyva Granted Breakthrough Therapy Designation by CDE
China-based JW Therapeutics (HKG: 2126) has announced that its Carteyva (relmacabtagene autoleucel injection) has been...
Mabwell’s 9MW2821 Granted Breakthrough Therapy Designation by CDE for Urothelial Carcinoma
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that the Center for Drug...
Hansoh and GSK’s HS-20093 Receives FDA Breakthrough Therapy Designation for Osteosarcoma
China-based Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692) and its UK partner GSK plc (LON:...
Sichuan Biokin’s BL-M08D1 and CSPC’s SYS6010 Eye Breakthrough Therapy Designations in China
The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical...
BioNova Pharmaceuticals’ BN104 Receives Breakthrough Therapy Designation in China
The China’s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.’s...
Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has...
GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation...
Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted...