BioCity's ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria
Second BTD Recognition Highlights Compound's Potential as Next-Generation Broad-Spectrum Renal Therapy SHANGHAI, June 26, 2025 /PRNewswire/ -- BioCity Biopharma ("BioCity") announced today that the Center for Drug Evaluation (CDE) of China's...
ArkBio's New Drug Application for ADHD Therapeutic Azstarys Accepted and Granted Priority Review by China NMPA
SHANGHAI, June 16, 2025 /PRNewswire/ -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) has officially accepted its New Drug Application (NDA) for Azstarys...
Hoth Therapeutics Secures Japanese Patent for Breakthrough HT-KIT Platform Targeting Mast Cell Diseases
Protection through 2039, ensuring long-term commercial exclusivity. NEW YORK, June 12, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing innovative therapies, today announced that they...
China's HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC
SHANGHAI, May 29, 2025 /PRNewswire/ -- The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan, China's first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with...
Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma
EBC-129 is the first made-in-Singapore antibody-drug conjugate (ADC) to enter clinical development. It selectively targets a tumour-specific N-glycosylated epitope on both CEACAM5 and CEACAM6. The Fast Track Designation highlights the potential of...
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...
IASO Bio Receives Orphan Drug Designation from the Saudi Food and Drug Authority for Equecabtagene Autoleucel
SHANGHAI, NANJING, China and SAN FRANCISCO, May 9, 2025 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of innovative cell therapies and...
Henlius Enters into License Agreement with Sandoz for Proposed Ipilimumab Biosimilar
Partnership covers North America, Europe, Japan, and Australia to accelerate global access of HLX13 in immuno-oncology combinations Henlius to receive $31 million upfront, and up to $270 million in milestones SHANGHAI, April 29, 2025 /PRNewswire/ --...
Telix's Illuccix PSMA-PET Imaging Agent Approved in France
New approval provides French hospitals and clinics with access to a proven PSMA-PET imaging agent MELBOURNE, Australia, April 29, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its...
Kelun-Biotech's novel ADC drug SKB518 has been granted the clearance of IND from the United States Food and Drug Administration (FDA)
CHENGDU, China, April 21, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company has been granted the clearance of investigational new drug (IND) application to initiated the clinical study...