Huahui Health’s Libevitug Earns FDA Breakthrough Designation for Chronic Hepatitis Delta Virus
Beijing-based biotech company Huahui Health, specializing in viral hepatitis, hepatology, and oncology, has announced that...
Breakthrough therapy
J&J’s Nipocalimab Receives FDA Breakthrough Therapy Designation for Sjögren’s Disease
US-based pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received...
Ascentage Pharma’s Lisaftoclax and AceLink Therapeutics’ AL01211 Receive FDA Designations
The Center for Drug Evaluation (CDE) website has indicated that China-based Ascentage Pharma’s (HKG: 6855)...
Chinese ADCs from Escugen, Hansoh, and MediLink Therapeutics Eye Breakthrough Designations in China
The Center for Drug Evaluation of the National Medical Products Administration (NMPA) has indicated on...
Jiangsu Hengrui’s HR19042 Earns Breakthrough Designation for Autoimmune Hepatitis Treatment in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
3D Medicines’ Envafolimab Earns NMPA Breakthrough Designation for TMB-H Solid Tumors
3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab...
Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that...
Biogen Gains FDA Breakthrough Status for Felzartamab in Kidney Transplant Rejection Treatment
Biogen Inc. (NASDAQ: BIIB) has secured breakthrough therapy designation (BTD) from the U.S. Food and...
Ascletis Pharma’s ASC40 Earns FDA Breakthrough Therapy Designation for Fibrotic MASH
China-based Ascletis Pharma Inc. (HKG: 1672) has announced that ASC40 (denifanstat), a fatty acid synthase...
Sichuan Biokin’s BL-B01D1 Earns Breakthrough Therapy Designation for Esophageal Cancer from China’s CDE
Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate...
Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food...
Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug...
Hengrui Pharmaceuticals’ HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently...
CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
The Center for Drug Evaluation (CDE) has indicated on its website that two indications for...
I-Mab’s Plonmarlimab Receives Breakthrough Therapy Designation in China for R/R MAS Treatment
China-based biopharmaceutical company I-Mab (NASDAQ: IMAB) has announced that its proprietary human granulocyte-macrophage colony-stimulating factor...
Jiangsu Hengrui’s ANGPTL3 Inhibitor SHR-1918 Earns Breakthrough Designation for HoFH Treatment
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced...
Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough...
China’s Evopoint Biosciences and UK’s GSK Eye Breakthrough Therapy Designations for Cancer Therapies
BEIJING/LONDON—The Center for Drug Evaluation (CDE) in China has indicated that Evopoint Biosciences’ EZH2 inhibitor...
Jiangsu Hansoh and GSK Receive FDA Breakthrough Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), a prominent Chinese pharmaceutical company, and its UK...
Jiangsu Hansoh Pharmaceutical and GSK Win FDA Breakthrough Therapy Designation for B7-H3 Targeted ADC in Small-Cell Lung Cancer
LONDON/HONG KONG—Jiangsu Hansoh Pharmaceutical Co., Ltd (HKG: 3692), in collaboration with UK-based GSK plc (NYSE:...