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Albumin-bound sirolimus (HB1901) is a nanoparticle albumin-bound (nab) formulation of the mTOR inhibitor sirolimus, developed by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. This intravenous formulation is designed to enhance the delivery and therapeutic index of sirolimus compared to traditional oral formulations. It is currently in Phase III clinical development for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, specifically in patients who have previously received CDK4/6 inhibitor therapy. By inhibiting the mTOR pathway, the drug aims to overcome resistance to endocrine therapy. In clinical trials, it is frequently evaluated in combination with agents such as fulvestrant. Beyond breast cancer, it is also being investigated for other indications, including malignant perivascular epithelioid cell tumors (PEComa) and solid tumors harboring TSC1 or TSC2 genetic alterations.
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