AN2025 (buparlisib)

AN2025 (buparlisib), the clinically most advanced drug candidate in our pipeline, is a global registrational trial-stage pan-PI3K inhibitor. With fast track designation from FDA, AN2025 is expected to be the first-in-class drug for treating recurrent or metastatic HNSCC.


Phase II clinical trial has demonstrated its robust antitumor efficacy. The combination of AN2025 and paclitaxel improved the median overall survival to over ten months. Currently, the Phase III multi-center clinical trial is ongoing.

 Mechanism of Action
Latest progress
The first patient has been dosed in the global phase III clinical trial for the treatment of recurrent or metastatic head and neck squamous cell carcinoma
Adlai Nortye Received NMPA, FDA and Health Canada Approval for AN2025 Phase III Clinical Trials.
Received Fast-Track designation from FDA

Head and neck cancer has become the sixth most common cancer worldwide. HNSCC accounted for more than 90% of head and neck cancer. Squamous cell carcinoma is a type of cancer with pathological changes in squamous cells and are found in the outer layers of the skin and mucous membranes. In 2020, the number of HNSCC patients worldwide has reached 838,700.


Among HNSCC patients, approximately 50% to 60% of them present with metastatic diseases, and approximately 85% of them do not respond or develop resistance to anti-PD1 therapy. In 2020, the patients with recurrent or metastatic HNSCC after anti-PD1 treatment were approximately 400,000, accounting for around 40-50% of the total number of HNSCC patients. There is still a large unmet medical need for the treatment of HNSCC with no response to PD-(L)1.