ABBISKO-B (02256.HK): IND application of oral pan-KRAS inhibitor ABSK211 approved by NMPA

NewTimeSpace News: On 19 August 2026, Abbisko Cayman Limited (stock code: 02256) announced in a voluntary announcement that its subsidiary Abbisko Therapeutics Co., Ltd. announced that China's National Medical Products Administration (NMPA) has approved the investigational new drug (IND) application of ABSK211, an oral, potent small-molecule pan-KRAS inhibitor with broad-spectrum activity against multiple KRAS alterations, intended for the treatment of patients with advanced solid tumors harboring KRAS alterations.

According to the announcement, ABSK211 previously obtained IND approval from the U.S. Food and Drug Administration (FDA) on 8 July, and obtaining IND approvals in both China and the US is a key milestone for ABSK211's global clinical development program. Preclinical studies showed that ABSK211 demonstrates broad-spectrum and potent inhibitory activity against multiple KRAS alterations including KRAS G12D, G12C, G12S, G12V, G13D and KRAS wild-type amplification, and exhibits favorable combination therapy potential in multiple tumor models (enhanced tumor growth inhibition when combined with PRMT5 inhibitors, cetuximab, immunotherapy and chemotherapy regimens).

The announcement states that Abbisko Therapeutics will soon initiate an open-label Phase I clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetic profile of ABSK211 in patients with advanced solid tumors harboring KRAS alterations; the Group cannot guarantee that ABSK211 will ultimately receive regulatory approval for marketing.

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