ABBISKO-B (02256.HK): Oral Pan-KRAS Inhibitor ABSK211 Cleared by FDA for Phase I Trial in KRAS-Altered Solid Tumours

NewTimeSpace News: On 13 July 2026, ABBISKO-B (02256.HK) issued a voluntary announcement. ABSK211, an orally administered, high-potency and highly selective small-molecule pan-KRAS inhibitor independently developed by the Group’s subsidiary Abbisko Therapeutics, has received IND clearance from the U.S. FDA. An open-label Phase I clinical study will be conducted in patients with advanced solid tumours harbouring KRAS genetic alterations to evaluate the product’s safety, tolerability, efficacy and pharmacokinetic profiles.

KRAS represents one of the most prevalent oncogenic driver genes in human malignancies, with genetic alterations occurring in approximately 90% of pancreatic cancers, 35% of colorectal cancers and 25% of lung cancers. Preclinical studies show that ABSK211 delivers broad and potent inhibitory activity against a wide spectrum of KRAS alterations, including KRAS G12D, G12C, G12S, G12V, G13D and wild-type KRAS amplification. In multiple tumour models, combination regimens with PRMT5 inhibitors, cetuximab, immunotherapy and chemotherapy exhibit enhanced anti-tumour effects compared with single-agent treatment.

ABSK211 has obtained IND approvals in both China and the United States. The Company cautions that there is no guarantee for the ultimate successful development and marketing approval of the candidate.