Sino Biopharm’s LM-302 Shows Promising Results in Phase III Trials for Gastric Cancer
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that LM-302, an innovative antibody-drug conjugate (ADC) developed...
Breakthrough therapy
RemeGen’s RC148 Granted Breakthrough Therapy Designation for NSCLC Treatment
RemeGen Co., Ltd. (SHA: 688331, HKG: 9995), a China-based biotech company, announced that its novel...
Sichuan Biokin’s Iza-Bren Granted FDA Breakthrough Therapy Designation for NSCLC
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that its bispecific antibody-drug conjugate (ADC), izalontamab...
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,...
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...