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...
Breakthrough therapy
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...
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...