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...
Breakthrough therapy
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...
Hengrui’s SHR‑1826 ADC Earns Breakthrough Therapy Designation for c‑Met Overexpressed NSCLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that SHR‑1826, an antibody‑drug conjugate (ADC) targeting...
RemeGen’s RC48 Wins Fourth Breakthrough Therapy Designation for Gastric Cancer Combo
RemeGen Ltd (SHA: 688331, HKG: 9995) announced that its core product, Disitamab Vedotin (RC48/Aidixi), has...
Kelun-Biotech’s sac-TMT Wins Breakthrough Therapy Designation for First‑Line NSCLC
Sichuan Kelun‑Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that sacituzumab tirumotecan (sac‑TMT, SKB264/MK‑2870), its TROP2‑directed...
Allist Pharmaceuticals Secures Breakthrough Therapy Designation for Furmonertinib in EGFR PACC‑Mutated NSCLC
Allist Pharmaceuticals Co., Ltd. (SHA: 688578) announced that furmonertinib has been added to the Breakthrough...
DualityBio’s DB-1310 Wins FTD as First HER3‑ADC for HR+/HER2‑ Breast Cancer
Duality Biotherapeutics, Inc. (HKG: 9606) announced that the U.S. FDA granted Fast Track Designation (FTD)...
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...
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...