IND Application for NTS071, Nutshell Therapeutics' p53 Y220C Allosteric Reactivator, Received US FDA clearance
SHANGHAI, May 4, 2025 /PRNewswire/ -- On April 23, 2025, Nutshell Therapeutics ( Shanghai ) Co., LTD. received IND clearance from the FDA to initiate P hase 1 clinical trial in the United States for its NTS071, a novel small molecule allosteric...
Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA
SHENZHEN, China, Feb. 14, 2025 /PRNewswire/ -- Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1b Inhalation Solution, a self-developed product by...
Lion TCR's Liocyx-M004 Receives FDA Clearance to Launch Global Multicenter Phase 2 Clinical Trial in HBV-Related Hepatocellular Carcinoma
SINGAPORE, Feb. 12, 2025 /PRNewswire/ -- On 12 Feb 2025, Lion TCR announced that its mRNA-encoded T-cell receptor (TCR)-T cell therapy product Liocyx-M004 has received clearance from the U.S. Food and Drug Administration (FDA) to initiate an...
Anti-HER2 Bispecific ADC JSKN003 Received Approval to Initiate a Phase III Clinical Study for the Treatment of HER2-positive Breast Cancer
SUZHOU, China, Feb. 6, 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...
Axcynsis Therapeutics Receives FDA Clearance for IND Application of AT03-65, a Differentiated CLDN6-Targeting ADC, Powered by AxcynDOT™ Technology
AT03-65 is the first program utilizing AxcynDOT™, a proprietary payload with a differentiated mechanism of action, to enter clinical development SINGAPORE, Jan. 15, 2025 /PRNewswire/ -- Axcynsis Therapeutics Pte Ltd ("Axcynsis"), a privately held...