Abbisko Cayman Limited (Abbisko-B) announced that its subsidiary, Abbisko Therapeutics, has obtained Investigational New Drug (IND) clearance from China’s National Medical Products Administration (NMPA) for ABSK211, an oral small-molecule pan-KRAS inhibitor targeting a broad spectrum of KRAS alterations in advanced solid tumours.

The Chinese IND follows U.S. Food and Drug Administration approval granted on 8 July 2026, positioning ABSK211 for parallel clinical development across the two largest pharmaceutical markets. An open-label Phase I study will commence shortly to evaluate safety, tolerability, efficacy and pharmacokinetics in patients with KRAS-altered advanced solid tumours.

KRAS mutations are among the most frequent oncogenic drivers, present in about 90 % of pancreatic cancers, 35 % of colorectal cancers and 25 % of lung cancers. Despite multiple pan-KRAS candidates in clinical pipelines, improvements in potency remain a key industry objective.

Pre-clinical data cited by Abbisko show that ABSK211 inhibited tumour cell proliferation at sub-nanomolar to nanomolar ranges across KRAS G12D, G12C, G12S, G12V, G13D and KRAS wild-type amplification models, with limited activity in normal KRAS wild-type cells. In vivo studies demonstrated pronounced and durable tumour regression and strong target engagement. Combination experiments with PRMT5 inhibitors, cetuximab, immunotherapy and chemotherapy indicated further enhancement of anti-tumour activity versus monotherapy.

The company emphasised that achieving dual IND clearances is a major milestone in its global development strategy for ABSK211. Commercial success is not yet assured, and shareholders are advised to exercise caution when trading Abbisko-B shares.