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...
China's NMPA Grants Breakthrough Therapy Designation for Anti-CTLA-4 Antibody Candidate Gotistobart (BNT316/ONC-392)
Designation granted for gotistobart (BNT316/ONC392) for the treatment of patients with squamous non-small cell lung cancer (sqNSCLC), an aggressive subtype of lung cancer Breakthrough Therapy designation will allow for an expedited development and...
Biparatopic HER2-targeting ADC JSKN003 Was Granted Another Breakthrough Therapy Designation for HER2-Positive Advanced Colorectal Cancer
SUZHOU, China, Oct. 20, 2025 /PRNewswire/ -- October 20, 2025- Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly announced that biparatopic HER2-targeting antibody-drug conjugate...
Abbisko Therapeutics Completes First Patient Dosing in Registrational Study of Irpagratinib for HCC
SHANGHAI, June 16, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) today announced that it has completed first patient dosing in a registrational study of irpagratinib, a self-developed and highly-selective small molecule FGFR4...
Kelun-Biotech's Novel CLDN18.2 ADC SKB315 IND in Combination with Tagolizumab Receives NMPA Approval for the First-Line Treatment of Gastric/Gastro-oesophageal Junction Cancer
CHENGDU, China, June 12, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that the Company has received a clinical trial notice approving the investigational new drug application for the its...