Hope Medicine Announces First Patient Dosed in the Phase III Clinical Trial for Endometriosis
SHANGHAI, March 25, 2026 /PRNewswire/ -- Hope Medicine Inc., a science-driven, clinical-stage innovative biopharmaceutical company, announced that the first patient has been dosed in the Phase III clinical trial of HMI-115, its first-in-class...
Akeso Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer
HONG KONG, Feb. 6, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) is pleased to announce that ivonescimab, its global first-in-class bispecific antibody targeting PD-1 and VEGF, has been granted its fifth Breakthrough Therapy Designation from the Center...
Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Breakthrough Therapy Designation by the FDA for the Treatment of PROC
SUZHOU, China, Dec. 20, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003, independently developed by the Company, and co-developed with JMT-Bio...
NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
NANJING, China and GAITHERSBURG, Md., Dec. 19, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation ("CDE")of...
Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025
HONG KONG, Dec. 11, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the presentation of a Phase II clinical study that included a longer-term efficacy data evaluating ivonescimab (a PD-1/VEGF bispecific antibody)...
Hope Medicine Inc.'s HMI-115 Received U.S. FDA Fast Track Designation, Accelerating Global Development
HMI-115 received FDA Fast Track Designation based on results from a Phase II clinical trial for endometriosis Mean dysmenorrhea pain score reduced by 42% Mean non-menstrual chronic pelvic pain score reduced by 52% Most patients maintained normal...
INCLUSION OF TINENGOTINIB TABLETS IN THE LIST OF PRODUCTS FOR PRIORITY REVIEW BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION
NANJING, China and GAITHERSBURG, Md., Dec. 4, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that Tinengotinib tablets have been included in the List of Products for Priority Review by the Center for Drug...
Henlius' Serplulimab (anti-PD-1 mAb) Granted Breakthrough Therapy Designation by China NMPA for Neo-/Adjuvant Treatment for Gastric Cancer
The first CDE-designated Breakthrough Therapy for perioperative gastric cancer, promising accelerated patient access. The world's first gastric cancer perioperative regimen replacing chemotherapy with immunotherapy alone in the adjuvant setting has...
Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer
HONG KONG, Nov. 3, 2025 /PRNewswire/ -- Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer...
Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Fast Track Designation by FDA for the Treatment of PROC
SUZHOU, China, Oct. 28, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that the biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug...