InnoCare Pharma’s Orelabrutinib-Mesutoclax Combination Receives Breakthrough Therapy Designation for Marginal Zone Lymphoma
InnoCare Pharma Limited (HKG: 9969, SHA: 688428) announced that the combination regimen of orelabrutinib and...
Breakthrough therapy
Sino Biopharmaceutical’s TQB2102 Receives Breakthrough Therapy Designation from NMPA for HER2-Low Breast Cancer
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Chia Tai Tianqing Pharmaceutical (CTTQ)‘s TQB2102,...
CSPC Pharmaceutical Secures Dual NMPA Breakthrough Therapy Designations for HER2-Positive Breast Cancer Combination
CSPC Pharmaceutical Group (HKG: 1093) announced that its self-developed docetaxel (albumin-bound) (HB1801) and Anbenitamab (KN026)—developed...
Sino Biopharmaceutical’s TRD205 Secures NMPA Breakthrough Therapy Designation for Chronic Post-Surgical Neuropathic Pain
Sino Biopharmaceutical (HKG: 1177) announced that TRD205, a Category 1 innovative drug self-developed by its...
Hengrui Pharmaceuticals Secures NMPA Breakthrough Therapy Designation for HRS-7058 in KRAS G12C-Mutant Pancreatic Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its Category 1 chemical...
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...
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...