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...
Kelun-Biotech Announces Breakthrough Therapy Designation Granted for Sacituzumab Tirumotecan (Sac-TMT) in Combination With Tagitanlimab in China for Certain Types of Non-Small Cell Lung Cancer
CHENGDU, China, June 11, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) (佳泰莱®) in combination with the...
Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT
SHANGHAI, June 10, 2025 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective,...
CARsgen's Satri-cel Granted Priority Review by the NMPA
SHANGHAI, May 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the Center for Drug Evaluation (CDE) of China's National Medical...
Abbisko Therapeutics Receives CDE Approval of Breakthrough Therapy Designation for Irpagratinib (ABSK011) in the Treatment of HCC
SHANGHAI, May 26, 2025 /PRNewswire/ -- Abbisko Therapeutics (HKEX Code: 02256) announced that its self-developed, highly selective small molecule FGFR4 inhibitor, irpagratinib (ABSK011), has received approval of Breakthrough Therapy Designation from...
Anti-HER2 Biparatopic ADC JSKN003 Has Been Granted Breakthrough-Therapy Designation for the Treatment of PROC
SUZHOU, China, March 18, 2025 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly announced that anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 has been...
CARsgen's Claudin18.2 CAR-T Therapy Satri-cel Granted Breakthrough Therapy Designation by the NMPA
SHANGHAI, March 3, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the Center for...
Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 (Anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer
SAN FRANCISCO and SUZHOU, China, Jan. 16, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of...
FDA Granted Orphan Drug Designation of LBL-024, An Anti-PD-L1/4-1BB Bispecific Antibody Developed by Leads Biolabs, for Treatment of Neuroendocrine Cancer
NANJING, China, Nov. 22, 2024 /PRNewswire/ -- Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-024, an anti-PD-L1/4-1BB bispecific antibody independently developed by the company with global...