Merck’s Calderasib-Pembrolizumab Combination Receives FDA Breakthrough Therapy Designation for First-Line KRAS G12C-Mutant NSCLC
Merck & Co., Inc. (MSD; NYSE: MRK) announced that the U.S. Food and Drug Administration...
Breakthrough therapy
D3 Bio Secures Breakthrough Therapy Designation for Elisrasib – Next-Generation KRAS G12C Inhibitor for First-Line NSCLC
D3 Bio announced that China’s Center for Drug Evaluation (CDE) of the National Medical Products...
Hansoh Pharma’s HS-10504 Receives NMPA Breakthrough Therapy Designation for Fourth-Generation EGFR Inhibitor in Resistant NSCLC
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s Center for Drug Evaluation (CDE)...
Biogen’s Zorevunersen Receives China Breakthrough Therapy Designation for Dravet Syndrome – First ASO Targeting SCN1A Gene in Rare Epileptic Encephalopathy
Biogen Inc. (NASDAQ: BIIB) announced that zorevunersen, an investigational antisense oligonucleotide (ASO) for Dravet syndrome,...
Servier’s B7-H4 ADC Emiltatug Ledadotin Receives FDA Breakthrough Therapy Designation for Advanced Adenoid Cystic Carcinoma
Servier announced on May 12, 2026, that the U.S. Food and Drug Administration (FDA) has...
CSPC Pharmaceutical Secures Second Breakthrough Therapy Designation for EGFR-Targeting ADC SYS 6010 in Esophageal Cancer
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced it has received a second Breakthrough Therapy Designation...
Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives Fifth NMPA Breakthrough Therapy Designation for Esophageal Cancer
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that its B7-H3-targeted antibody-drug conjugate (ADC) HS-20093...
Wenda Pharmaceutical Secures NMPA Breakthrough Therapy Designation for NHWD-870 in Rare NUT Carcinoma
Zhejiang Wenda Pharmaceutical Technology Co., Ltd. announced it has received Breakthrough Therapy Designation (BTD) from...
Keymed Biosciences Secures NMPA Breakthrough Therapy Designation for CM336 in AL Amyloidosis
Keymed Biosciences Inc. (HKG: 2162) announced that its BCMA×CD3 T cell engager (TCE), CM336 (OM336),...
Innovent Biologics Secures Third Breakthrough Therapy Designation for IBI363 in MSS/pMMR Colorectal Cancer
Innovent Biologics, Inc. (HKG: 1801) announced that its first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein,...
Hansoh Pharmaceutical’s B7-H3 ADC HS-20093 Receives China BTD for Advanced Prostate Cancer
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that its investigational antibody-drug conjugate (ADC) HS-20093...
GSK’s Efimosfermin Receives Dual Regulatory Designations for MASH Treatment – Breakthrough Therapy and PRIME Status Support Phase III Development
GlaxoSmithKline plc (GSK, NYSE: GSK) announced on April 27, 2026, that efimosfermin, a once-monthly investigational...
Hengrui’s Trastuzumab Rezetecan Receives CDE Breakthrough Therapy Designation for First-Line HER2+ Metastatic Breast Cancer in Combination with Pertuzumab
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its proprietary HER2-targeted antibody-drug...
Hansoh Pharma’s B7-H3 ADC HS-20093 Secures Fourth NMPA Breakthrough Therapy Designation for NSCLC Combination Therapy
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) has announced that its investigational antibody-drug conjugate (ADC),...
Hengrui Pharma’s Nectin-4 ADC SHR-A2102 Granted Second NMPA Breakthrough Therapy Designation for Cervical Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its Category 1 therapeutic...
GenFleet Therapeutics Secures First‑Ever NMPA Breakthrough Designation for KRAS G12D Inhibitor in Pancreatic Cancer
GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that China’s National Medical Products Administration (NMPA) has granted...
Haisco Pharmaceutical Secures NMPA Breakthrough Therapy Designation for HSK39004 Inhalation Powder in COPD, Following Successful Phase II Lung Function Data
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that China’s National Medical Products Administration (NMPA)...
Sanofi’s Venglustat Wins FDA Breakthrough Therapy Designation – Oral Brain-Penetrant GCSi Targets Gaucher Disease Type 3 Neurological Symptoms
Sanofi (NASDAQ: SNY) announced that venglustat received Breakthrough Therapy Designation (BTD) from the U.S. Food...
MicroPort Endovascular’s Hector Wins FDA Breakthrough Designation – Multi‑Branch Stent Graft Targets Complex Aortic Arch Lesions
Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) announced that its Hector thoracic aortic multi‑branch stent...
GenFleet’s GFH375 Wins CDE Breakthrough Therapy Designation – Oral KRAS G12D Inhibitor for NSCLC
GenFleet Therapeutics (Shanghai) Inc. (HKG: 2595) announced that GFH375, an oral KRAS G12D (ON/OFF) inhibitor, has...