Zelgen’s ZG006 Wins BTD for Neuroendocrine Carcinoma as First DLL3 Trispecific
Suzhou Zelgen Biopharmaceuticals Co., Ltd. (SHA: 688266) announced that ZG006, the world’s first trispecific antibody...
Breakthrough therapy
Henlius Serplulimab Wins BTD for Gastric Cancer Perioperative Treatment, a China First
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that its anti‑PD‑1 monoclonal antibody serplulimab (HANSIZHUANG, Hetronifly...
Akeso’s ivonescimab (AK112) Receives Fourth Breakthrough Therapy Designation in China for Triple‑Negative Breast Cancer
Akeso Inc. (HKG: 9926) announced that its proprietary bispecific antibody ivonescimab (AK112) has been granted...
CSPC Pharmaceutical Secures Breakthrough Therapy Designation for JSKN003 in HER2‑Positive Colorectal Cancer
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that JSKN003, a HER2‑bi‑epitope targeted antibody‑drug conjugate (ADC)...
Sino Biopharmaceutical’s Partner CTTQ Secures Breakthrough Therapy Designation for TQ‑B3234 Capsule in China
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of China‑based Sino Biopharmaceutical Ltd. (HKG: 1177), today...
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...
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...