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Huaier granule is a traditional Chinese medicine (TCM) and a Class I innovative anti-cancer drug in China, developed by Qidong Gaitianli Medicines Co., Ltd. It is an aqueous extract derived from the dried fruiting body of the fungus *Trametes robiniophila Murr* (also known as *Vanderbylia robiniophila*). The formulation primarily consists of polysaccharides, proteoglycans, and amino acids. Huaier granule is widely used as an adjuvant therapy to prevent recurrence and metastasis following surgical resection or ablation in various malignancies, most notably hepatocellular carcinoma (HCC), breast cancer, and non-small cell lung cancer (NSCLC). Its mechanism of action involves the modulation of the gut microbiota-gut-liver axis, suppression of the MAPK and PI3K/AKT/HIF-1α signaling pathways, induction of cell cycle arrest (G0/G1 phase), and enhancement of anti-tumor immunity through macrophage polarization and T-cell activation.
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