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Abbisko Therapeutics’ Oral Small-Molecule KRAS G12D Inhibitor ABSK141 Completed First Patient Dosing

Mar 04,2026
By Abbisko
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4 March 2026, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that the first patient has been successfully dosed in the Phase I/II clinical study of ABSK141, an oral, highly potent, and selective small-molecule KRAS G12D inhibitor, for the treatment of patients with advanced solid tumors harboring KRAS G12D mutations. 

KRAS is one of the most common oncogenic driver genes in human cancers, with G12D being the predominant mutation subtype. It is widely present in various solid tumors such as pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC). The G12D mutation induces specific conformational changes in the KRAS protein, which has long been regarded as an "undruggable" target, posing significant challenges to the development of targeted therapies. To date, no targeted therapy for KRAS G12D mutations has been approved worldwide.

This first-patient dosing was completed in an open-label Phase I/II clinical study. The study received Investigational New Drug (IND) approvals from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) in December 2025.

The successful advancement of the ABSK141 clinical study marks an important milestone for Abbisko Therapeutics in the field of KRAS-targeted therapy, and is expected to provide a transformative treatment option for patients with KRAS G12D-mutated solid tumors, redefining the landscape of KRAS-targeted therapy.

About ABSK141

ABSK141 is a novel, oral small-molecule KRAS G12D inhibitor independently designed and developed by Abbisko Therapeutics. It binds selectively to the KRAS G12D mutant protein, thereby blocking downstream signaling pathways and inhibiting tumor cell proliferation. Preclinical studies have demonstrated that ABSK141 possesses potential best-in-class oral bioavailability across multiple animal models and exhibits strong anti-tumor activity in various human cancer cell line-derived xenograft (CDX) models, including pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC).

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.


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