3 November 2025, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that its oral small-molecule PD-L1 inhibitor, ABSK043, combined with KRAS G12C inhibitor, Glecirasib, from Shanghai Allist Pharmaceuticals Co., Ltd. ("Allist" hereafter, SSE code: 688578.SS) has completed first patient dosing in a phase II study for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) harboring KRAS G12C mutation.

This open-label phase II study is designed to evaluate the safety, tolerability, and efficacy of ABSK043 in combination with Glecirasib in patients with locally advanced or metastatic NSCLC harboring KRAS G12C mutation. The study obtained Investigational New Drug approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) in August 2025. This successful first patient dosing marks a significant step forward in the development of this promising combination regimen.

Approximately 14% of non–small cell lung cancers harbor a KRAS G12C mutation[1-3]. In a previous phase I clinical study in patients with advanced solid tumors, ABSK043 demonstrated favorable safety and promising anti-tumor activity as a single agent, with high response rates observed in the subset of patients with high PD-L1 expression, and EGFR or KRAS mutations.

About ABSK043

ABSK043 is a novel, orally bioavailable, highly selective small molecule PD-L1 inhibitor wholly owned by Abbisko Therapeutics. Tumor cells can exploit immune checkpoints such as PD-1 and its ligand PD-L1 to evade immune detection and clearance, thereby suppressing or limiting T-cell responses. ABSK043 selectively binds to the PD-L1 receptor and induces its internalization from the cell surface, effectively inhibiting the PD-1/PD-L1 interaction and alleviating PD-L1-mediated suppression of T-cell activation. In preclinical models, ABSK043 has demonstrated anti-tumor efficacy comparable to approved PD-L1 antibodies. While several PD-1/PD-L1 monoclonal antibodies have been approved worldwide, there are currently no approved orally bioavailable PD-1/PD-L1 small molecule drugs. ABSK043 is currently being explored in an ongoing Phase I clinical trial for advanced solid tumors in Australia and China.

About Glecirasib

Glecirasib is a KRAS G12C inhibitor approved for the treatment of NSCLC by the China NMPA.A number of clinical trials are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor, AST-24082, in NSCLC, and monotherapy trials in pancreatic cancer. Glecirasib received orphan drug designation in the United States and breakthrough therapy designation in China for the treatment of pancreatic cancer. 

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.

About Allist

Shanghai Allist Pharmaceuticals Co., Ltd, founded in March, 2004, is an innovative pharmaceutical company with a fully integrated system for research and development, manufacturing, and commercialization of novel oncology drugs with a purpose to meet with medical needs across the globe. On December 2nd, 2020, Shanghai Allist Pharmaceuticals Co., Ltd. was officially listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange (stock number: 688578).

Reference

[1]Liu P, Wang Y, Li X. Targeting the untargetable KRAS in cancer therapy. Acta Pharm Sin B. 2019 Sep;9(5):871-879.

[2]Pakkala S, Ramalingam SS. Personalized therapy for lung cancer: striking a moving target. JCI Insight. 2018 Aug 9;3(15):e120858.

[3]Nassar AH, Adib E, Kwiatkowski DJ. Distribution of KRAS G12C Somatic Mutations across Race, Sex, and Cancer Type. N Engl J Med. 2021 Jan 14;384(2):185-187.