Adlai Nortye

Adlai Nortye is a clinical-stage, global biopharmaceutical company with a dual presence in the United States and China, operating research and development as well as clinical operation centers in both countries. Founded in 2004, the company focuses on developing treatments for cancer through a strategy that combines in-house research with collaborative innovation. The company is led by founder, Chairman, and CEO, Lu Yang.

Adlai Nortye's business model is centered on the discovery, development, and commercialization of oncology therapies. It has established a pipeline of drug candidates targeting various cancers, aiming to address significant unmet needs in the global oncology market. The firm generates value by advancing these candidates through the rigorous phases of clinical trials, with the ultimate goal of obtaining regulatory approval and bringing new treatments to patients worldwide. Strategic partnerships with other leading pharmaceutical companies are a key component of its approach, enabling the co-development of promising therapies.

The company's product pipeline includes several candidates at different stages of clinical development. AN2025 (buparlisib), a PI3K inhibitor, has received Fast Track Designation from the FDA and is in a global Phase III trial. It is being studied in combination with paclitaxel as a potential second-line treatment for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) who have not responded to PD-1 inhibitors. Another key candidate is AN0025 (palupiprant), an EP4 antagonist designed to modulate the tumor microenvironment. It is currently in a Phase Ib trial in combination with Keytruda® for various solid tumors and a Phase II study with chemoradiotherapy for locally advanced cancers. Furthermore, Adlai Nortye is developing AN4005, an internally developed oral small molecule PD-L1 inhibitor, which is undergoing Phase I trials in both the U.S. and China. The company is also exploring a triple combination therapy using AN2025, AN0025, and Roche's Tecentriq for solid tumors with PI3KCA mutations.

Keywords: biopharmaceutical, oncology, cancer treatment, clinical-stage, HNSCC, PI3K inhibitor, EP4 antagonist, PD-L1 inhibitor, buparlisib, palupiprant, solid tumors, tumor microenvironment, drug development, NASDAQ:ANL, Lu Yang, Head and Neck Cancer, immunotherapy, targeted therapy, pharmaceutical research, global clinical trials