Cosunter’s GST-HG131 Granted Breakthrough Therapy Designation for HBV Treatment in China
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) announced that it has received breakthrough therapy...
Breakthrough therapy
Jiangsu CTTQ’s TQB2102 Receives Breakthrough Therapy Designation for HER2+ Breast Cancer
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co.,...
Medilink Therapeutics’ YL201 Wins FDA Breakthrough Therapy Designation for SCLC
Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US...
Sino Biopharmaceutical’s TDI01 Receives Breakthrough Therapy Designation for cGVHD Treatment
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its Class 1 drug TDI01 has been...
Suzhou Sinus Medtech Wins FDA Breakthrough Designation for oHCM Ablation System
Suzhou Sinus Medical Technologies Co., Ltd., a China-based medical device innovator, announced that its in-house...
Innovent Biologics’ IBI363 Receives Breakthrough Therapy Designation from CDE
China-based Innovent Biologics, Inc. (HKG: 1801) announced that its first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion...
Abbisko Therapeutics’ FGFR4 Inhibitor Irpagratinib Granted Breakthrough Therapy Designation for HCC
Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) announced that it has received Breakthrough Therapy...
Fosun Pharma’s FCN-159 Granted Breakthrough Therapy Designation for Pediatric LCH
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that its novel small-molecule...
InnoCare Pharma’s Mesutoclax Granted Breakthrough Therapy Designation for R/R MCL
Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that the Center for Drug Evaluation...
Roche’s VENTANA TROP2 Device Receives FDA Breakthrough Designation
Swiss giant Roche AG (SWX: ROG, OTCMKTS: RHHBY) announced that its VENTANA TROP2 (EPR20043) RxDx...
3SBio’s 707 Bispecific Antibody Receives BTD for First-Line NSCLC in China
China-based 3SBio Inc. (HKG: 1530) has announced the receipt of Breakthrough Therapy Designation (BTD) from...
Hansoh’s HS-20093 ADC Earns BTD for Advanced NSCLC from China’s NMPA
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that China’s National Medical Products...
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...
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...