BioNova Pharmaceuticals’ BN104 Receives Breakthrough Therapy Designation in China
The China’s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.’s...
Breakthrough therapy
Jiangsu Hengrui’s Trastuzumab Rezetecan on Track for NMPA’s Breakthrough Therapy Designation
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading pharmaceutical company based in China, has...
GSK’s Jemperli Receives FDA Breakthrough Therapy Designation for Rectal Cancer Treatment
UK-based pharmaceutical giant GSK (NYSE: GSK) has announced that it has received Breakthrough Therapy Designation...
Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted...
Fujian Cosunter Pharmaceutical’s GST-HG141 Earns Breakthrough Designation for Chronic Hepatitis B
Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a China-based pharmaceutical company, has announced that it...
HutchMed’s Orpathys Receives Breakthrough Therapy Designation in China for Advanced Lung Cancer
HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that its MET inhibitor, Orpathys (savolitinib),...
ImmunoTech Biopharm’s CAR-T-19 Earns Breakthrough Therapy Designation for B-ALL Treatment
China-based chimeric antigen receptor T-cell (CAR-T) specialist Immunotech Biopharm Ltd (HKG: 6978) has announced receiving...
Daiichi Sankyo and AstraZeneca’s Datopotamab Deruxtecan Earns FDA Breakthrough Therapy Designation
Partners Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) have jointly announced that their...
Jiangsu Hengrui’s SHR-A2102 Earns Breakthrough Therapy Designation for Urothelial Carcinoma
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received breakthrough therapy...
Sacituzumab Tirumotecan Earns FDA Breakthrough Therapy Designation for EGFR Mutated NSCLC
Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme...
InxMed’s Ifebemtinib Earns Breakthrough Therapy Designation for NSCLC Treatment in China
China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the...
Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG:...
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...
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...