ABBISKO-B (02256.HK): First patient dosed in Phase I trial of pan-KRAS inhibitor ABSK211, preclinically covering multiple KRAS alterations

NewTimeSpace News: On 31 August 2026, Abbisko Cayman Limited (stock code: 02256) voluntarily announced that its subsidiary, Shanghai Abbisko Biomedical Technology Co., Ltd., has announced that the first patient has been dosed in the Phase I clinical trial of ABSK211, an oral, highly potent small-molecule pan-KRAS inhibitor broadly covering multiple KRAS alterations, in patients with advanced solid tumors harboring KRAS gene alterations; the study aims to evaluate the safety, tolerability, efficacy and pharmacokinetic profile of ABSK211 in these patients.

According to the announcement, KRAS is one of the most frequently altered oncogenic driver genes in human cancers, with KRAS alterations present in approximately 90% of pancreatic ductal adenocarcinoma, approximately 45% of colorectal cancer and approximately 34% of non-small cell lung cancer. Preclinical studies showed that ABSK211 exhibits broad-spectrum and potent inhibitory activity against multiple major KRAS alterations including KRAS G12D, G12C, G12S, G12V, G13D and KRAS wild-type amplification; in vitro, ABSK211 significantly inhibited the proliferation of multiple KRAS-mutant tumor cell lines at sub-nanomolar to nanomolar concentrations, with little activity against KRAS wild-type cells with normal copy numbers; in vivo studies further showed that ABSK211 induced significant and durable tumor regression in multiple KRAS-altered tumor models, with potent target engagement.

In addition, ABSK211 demonstrated favorable combination potential across multiple tumor models; when combined with PRMT5 inhibitors, cetuximab, immunotherapy and chemotherapy regimens, it further enhanced antitumor activity with potential to prolong durable responses, providing a strong basis for exploring ABSK211-based combination strategies.

ABSK211 is a novel investigational oral small-molecule pan-KRAS inhibitor independently developed by Abbisko, which has received IND approvals from both China's NMPA and the US FDA, with global clinical development advancing as planned following the first patient dosing. Abbisko, established in 2016, is a biopharmaceutical company committed to researching, discovering and developing innovative and differentiated drugs; its independently developed Class 1 new drug pimatinib has been approved for marketing by the NMPA, with dozens of other drug candidates in clinical development.

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