1 December 2025, 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 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.

The cleared study is an open-label Phase I/II clinical trial designed to assess the safety, tolerability, efficacy and pharmacokinetics of ABSK141 in patients with advanced solid tumors harboring KRAS G12D mutations.

KRAS is one of the most common oncogenic driver genes in human cancers, with the G12D mutation being the most prevalent subtype. KRAS G12D mutations occur across multiple solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC). Due to the unique conformational changes caused by the G12D mutation, drug development targeting this mutation has long been considered highly challenging, and no targeted therapies against KRAS G12D has yet been approved.

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.