CSPC Pharma gets U.S. nod for SYH2051 trial

CSPC Pharmaceutical Group Limited (HKEX:1093) announced that its independently developed drug, SYH2051, a selective ATM inhibitor, has received clinical trial approval from the U.S. Food and Drug Administration (FDA). SYH2051 had previously obtained approval for clinical trials in China in June 2023. The drug targets advanced solid tumors by inhibiting ATM protein kinase, disrupting DNA repair, and arresting cell cycle progression. Preclinical studies have demonstrated the drug's selectivity and effectiveness. CSPC Pharma has completed Phase Ia trials for monotherapy in China, establishing safety and pharmacokinetic profiles. The company is currently conducting clinical trials combining SYH2051 with radiotherapy, antibody-drug conjugates (ADCs), and chemotherapy.