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...
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...