CSPC PHARMA (01093): Injection S-1 (albumin-binding type) for the treatment of epithelioid hemangioendothelioma Phase II clinical trial has officially started at the first center in China.

CSPC PHARMA (01093) announced that the Phase II clinical trial of their independently developed injection of sirolimus (albumin bound) for the treatment of patients with progressive or symptomatic epithelioid hemangioendothelioma has officially started at the first center in China. This product belongs to the macrolide immunosuppressant class, and is a highly selective inhibitor of the mammalian target of rapamycin (mTOR) protein. Sirolimus can bind with the immunophilin FKBP12 to form an immunosuppressive complex, blocking the activation of the mTOR pathway. It can inhibit cytokine-mediated T lymphocyte activation and proliferation, block the cell cycle transition from G1 phase to S phase, and also down-regulate antibody production in the body, demonstrating strong immunosuppressive effects. This product is classified as a Class 2.2 modified new chemical drug. The clinical trial is a multicenter, open-label, non-randomized Phase II clinical trial, aiming to include patients with histologically confirmed epithelioid hemangioendothelioma who are not suitable for radical surgery and who, as assessed by the researchers, require systemic systemic treatment for their progressive or symptomatic disease. The trial aims to evaluate the efficacy and safety of this product in patients with progressive or symptomatic epithelioid hemangioendothelioma. Currently, subject recruitment and screening are actively ongoing.