13 July 2026, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ABSK211, an oral, highly potent and selective small-molecule pan-KRAS inhibitor, for the treatment of patients with advanced solid tumors harboring KRAS alterations.

The cleared study is an open-label Phase I clinical trial designed to assess the safety, tolerability, efficacy and pharmacokinetics of ABSK211 in patients with advanced solid tumors harboring KRAS alterations.

KRAS is one of the most common oncogenic driver genes in human cancers and is highly prevalent across multiple solid tumor types, including approximately 90% of pancreatic cancers, 35% of colorectal cancers, and 25% of lung cancers. Due to the complexity and diversity of KRAS alteration subtypes, KRAS has long been regarded as one of the most challenging targets in oncology. While several pan-KRAS inhibitors have entered clinical development, there remains a critical need for enhanced potency.

Preclinical studies demonstrated that ABSK211, a novel oral pan-KRAS inhibitor, exhibited broad and potent inhibitory activity across multiple KRAS alterations, including KRAS G12D, G12C, G12S, G12V, G13D, and KRAS wild-type amplification. In vitro studies showed that ABSK211 significantly inhibited proliferation of multiple KRAS-mutant tumor cell lines at sub-nanomolar to nanomolar concentrations, while exhibiting minimal activity in KRAS wild-type cell lines with normal copy number. In vivo studies further demonstrated that ABSK211 induced deep and durable tumor regression across multiple KRAS-altered tumor models, with robust target engagement.

In addition, ABSK211 demonstrated strong potential in combination therapy settings across multiple tumor models. Study results showed that combining ABSK211 with PRMT5 inhibitors, cetuximab, immunotherapy, and chemotherapy further enhanced tumor growth inhibition and improved durability compared to monotherapy, supporting future exploration of combination treatment strategies.

About ABSK211

ABSK211 is a novel investigational oral, highly potent and selective small molecule pan-KRAS inhibitor independently developed by Abbisko Therapeutics. It is designed to target a broad spectrum of KRAS alterations, including common KRAS mutation subtypes and selected amplification settings. Preclinical data demonstrated encouraging anti-tumor activity and favorable selectivity of ABSK211 in both monotherapy and combination treatment settings, supporting its potential to provide a new therapeutic option for patients with KRAS-altered solid tumors. 

About Abbisko Therapeutics

Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology.

Please visit www.abbisko.com for more information.