Affinity today announced that the Investigational New Drug (IND) application for QHL-236 (Legutaxel for injection), its novel precision-targeted paclitaxel-based anti-cancer drug, has been granted implied approval by the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors.Paclitaxel, a natural anti-cancer agent, is widely used clinically for the treatment of ovarian cancer, breast cancer, pancreatic cancer, prostate cancer, as well as lung cancer, colorectal cancer, melanoma, head and neck cancer, lymphoma and brain tumors. Both paclitaxel and albumin-bound paclitaxel are associated with hematologic toxicity of myelosuppression, and share other adverse reactions including hypersensitivity, neurotoxicity, cardiovascular toxicity, gastrointestinal reactions, hepatic toxicity and alopecia.

Legutaxel is a novel precision-targeted taxane drug. Its pharmacological activity is inactivated in normal tissues and blood circulation, and the drug only accumulates and releases active components at tumor sites, thereby significantly reducing chemotherapy-related toxicities and improving anti-tumor efficacy. Meanwhile, due to its precision-targeted nature, it is non-toxic to the immune system and circulating immune cells, making it suitable for combination with immunotherapy for the treatment of various advanced solid tumors.