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...
Breakthrough therapy
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...
Akeso’s ivonescimab (AK112) Receives Fourth Breakthrough Therapy Designation in China for Triple‑Negative Breast Cancer
Akeso Inc. (HKG: 9926) announced that its proprietary bispecific antibody ivonescimab (AK112) has been granted...
CSPC Pharmaceutical Secures Breakthrough Therapy Designation for JSKN003 in HER2‑Positive Colorectal Cancer
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that JSKN003, a HER2‑bi‑epitope targeted antibody‑drug conjugate (ADC)...
Sino Biopharmaceutical’s Partner CTTQ Secures Breakthrough Therapy Designation for TQ‑B3234 Capsule in China
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of China‑based Sino Biopharmaceutical Ltd. (HKG: 1177), today...
BeOne Medicines Receives FDA Breakthrough Therapy Designation for Sonrotoclax in Relapsed Mantle Cell Lymphoma
BeOne Medicines Ltd. (NASDAQ: ONC; HKG: 6160; SHA: 688235) announced today that the U.S. Food...
Sino Biopharma Subsidiary Secures Breakthrough Therapy Designation for TQB2102 ADC Targeting HER2‑Positive Colorectal Cancer
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a wholly‑owned subsidiary of China‑listed Sino Biopharmaceutical Ltd....
Sichuan Biokin Secures Second Breakthrough Therapy Designation for Izalontamab Brengitecan in Advanced Urothelial Carcinoma
China‑based Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today that the Center for Drug...
Hengrui Pharma Secures Breakthrough Therapy Designation for SHR‑1501 in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its investigational injectable SHR‑1501...
Jiangsu Hengrui HRS‑5635 Seeks Breakthrough Therapy Designation for Chronic Hepatitis B
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its next‑generation small‑interfering RNA...
Biokin Pharma Secures Breakthrough Therapy Designation for izalontamab with BMS
China‑based Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) announced today that its bispecific antibody‑drug conjugate...
Sino Biopharma’s Zongertinib Receives Second Breakthrough Designation for NSCLC
On August 20, 2025, Sino Biopharmaceutical Limited (HKG: 1177) announced that its selective HER2 tyrosine...