Hengrui’s Trastuzumab Rezetecan and Adebrelimab Granted Breakthrough Therapy Designation by China’s NMPA
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced on August 11, 2025,...
Breakthrough therapy
Sino Medical Sciences’ COMETIU Stent System and COMEX Catheter Receive FDA Breakthrough Designation
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received breakthrough devices...
Cryofocus Medtech’s Asthma Cryoablation System Granted FDA Breakthrough Device Designation
China-based Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922) announced today that its self-developed asthma cryoablation...
Fosun Pharmaceutical Launches Phase III Study for Fumaining in Pediatric Low-Grade Glioma
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced the initiation of a...
Zelgen’s ZG006 Receives Breakthrough Therapy Designation for Advanced Small Cell Lung Cancer
China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received breakthrough therapy...
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...
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)...