20 August 2025, Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has cleared the IND application for Abbisko’s investigational oral PD-L1 inhibitor, ABSK043, combined with  Shanghai Allist Pharmaceuticals Co., Ltd. ("Allist" hereafter, SSE code: 688578.SS) KRAS G12C inhibitor, glecirasib, for the treatment of NSCLC patients with KRAS G12C mutation. In March, Abbisko Therapeutics and Allist entered into a cooperation agreement to explore ABSK043 in combination with glecirasib.

A clinical study of NSCLC will be conducted under the title “A Phase II, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of ABSK043 Combined With Glecirasib in Patients With KRAS G12C Mutated, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)”.

The parties previously disclosed a separate collaboration to explore the combination of ABSK043 and furmonertinib (IVESA), developed by Allist, for the treatment of advanced non-small cell lung cancer. First-patient dosing for this study occurred in December 2024.

Results from an updated Phase I study showed that ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent, with higher response rates 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 (AST-24081) is a KRAS G12C inhibitor. 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. Additionally, the pancreatic cancer indication has received orphan drug designation in the United States and breakthrough therapy designation in China. In May 2025, Glecirasib was approved for market launch by the China NMPA.

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.

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. In accordance with its development concept“Advancing Long Life with Innovation of Science and Technology”, Allist is dedicated to self-develop First-in-class and Best-in-class drug candidates. After 20 years of endeavor, Allist has successfully developed and received approvals of two innovative drugs by its own. 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).