BeOne Medicines Receives FDA Breakthrough Therapy Designation for Sonrotoclax in Relapsed Mantle Cell Lymphoma
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced today that the U.S. Food...
Breakthrough therapy
Sino Biopharma Subsidiary Secures Breakthrough Therapy Designation for TQB2102 ADC Targeting HER2‑Positive Colorectal Cancer
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a wholly‑owned subsidiary of China‑listed Sino Biopharmaceutical Ltd....
Sichuan Biokin Secures Second Breakthrough Therapy Designation for Izalontamab Brengitecan in Advanced Urothelial Carcinoma
China‑based Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today that the Center for Drug...
Hengrui Pharma Secures Breakthrough Therapy Designation for SHR‑1501 in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its investigational injectable SHR‑1501...
Jiangsu Hengrui HRS‑5635 Seeks Breakthrough Therapy Designation for Chronic Hepatitis B
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its next‑generation small‑interfering RNA...
Biokin Pharma Secures Breakthrough Therapy Designation for izalontamab with BMS
China‑based Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today that its bispecific antibody‑drug conjugate...
Sino Biopharma’s Zongertinib Receives Second Breakthrough Designation for NSCLC
On August 20, 2025, Sino Biopharmaceutical Limited (HKG: 1177) announced that its selective HER2 tyrosine...
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...
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...