CSPC PHARMA (HKEX: 01093) has announced that the Phase II clinical trial for its self-developed injectable sirolimus (albumin-bound) has officially commenced at the first site in China. The trial is for treating patients with progressive or symptomatic epithelioid hemangioendothelioma.

The product is a macrolide immunosuppressant and a highly selective inhibitor of the mammalian target of rapamycin (mTOR). By binding to the immunophilin FKBP12, sirolimus forms an immunosuppressive complex that blocks mTOR pathway activation. This mechanism inhibits cytokine-mediated T-lymphocyte activation and proliferation, halting the cell cycle from the G1 to S phase, while also downregulating antibody production, resulting in potent immunosuppressive effects.

Classified as a chemical drug 2.2 category modified new drug, this Phase II study is designed as a multi-center, open-label, non-randomized trial. It aims to enroll patients with histologically confirmed, progressive, or symptomatic epithelioid hemangioendothelioma who are unsuitable for radical surgery and, in the investigator's assessment, require systemic therapy. The primary objectives are to evaluate the efficacy and safety of the product in this patient population.

Patient recruitment and screening for the trial are currently being actively advanced.