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...
Breakthrough therapy
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...
Hengrui’s Trastuzumab Rezetecan Wins Eighth BTD for First-Line HER2+ NSCLC in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that trastuzumab rezetecan (SHR-A1811), its HER2-targeted antibody-drug...
Sanofi’s Wayrilz Wins FDA Breakthrough and Japan Orphan Designation for Rare Blood Disorder
Sanofi (NASDAQ: SNY) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy...
Hengrui Pharma’s HRS-4642 Wins Breakthrough Therapy Designation for KRAS G12D Pancreatic Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS-4642, its KRAS G12D-targeting...
Akeso’s Ivonescimab Secures Fifth Breakthrough Therapy Designation for Biliary Tract Cancer in China
Akeso, Inc. (HKG: 9926) announced that Yidafang (ivonescimab) has been awarded Breakthrough Therapy Designation (BTD)...
Lilly’s Sofetabart Wins FDA Breakthrough Status for Platinum‑Resistant Ovarian Cancer
Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has...
Novartis’s Ianalumab Wins FDA Breakthrough Therapy Designation for Sjögren’s Disease
Novartis AG (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough...
Ipsen’s IPN60340 Wins FDA Breakthrough Therapy Designation for First‑Line AML in Combination
Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced that the U.S. Food and Drug Administration (FDA) has granted...