sirolimus for injection (albumin-bound) (SRL-HSA) / CSPC Pharma - LARVOL DELTA

Intravenous sirolimus (albumin-bound HB1901) in malignant perivascular epithelioid cell tumors (PEComas): a multicenter, open-label, phase Ib/III trial update (ESMO 2026) - No abstract available

Clinical • Oncology

CSPC Pharmaceutical Group has announced that its independently developed Sirolimus for Injection (Albumin-Bound) has had its new drug application accepted by China’s National Medical Products Administration and granted inclusion in the Breakthrough Therapy Drug Program with Priority Review status (TipRanks) - "The macrolide immunosuppressant, a highly selective mTOR inhibitor, is being proposed for unresectable locally advanced or metastatic malignant PEComa, a rare tumour type lacking a unified standard treatment. The submission is supported by a pivotal Phase Ib/II study in PEComa patients naïve to mTOR inhibitors, where the product met its primary endpoint and showed significant efficacy advantages over conventional therapies, with rapid, deep tumour responses and a favourable safety profile."

Breakthrough therapy • China filing • Priority review • Perivascular Epithelioid Cell Tumor • Soft Tissue Sarcoma

A Phase 2 Study of Sirolimus for Injection (Albumin-bound) in Patients With Progressive or Symptomatic Epithelioid Hemangioendothelioma (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2 trial • Oncology

A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=114 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Sirolimus for Injection (Albumin Bound) Combined With Octreotide Long-acting Injection in Patients With Metastatic Gastroenteropancreatic Neuroendocrine Tumors (clinicaltrials.gov) - P2/3 | N=243 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2/3 trial • Neuroendocrine Tumor • Solid Tumor

Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy (clinicaltrials.gov) - P2 | N=78 | Active, not recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors (clinicaltrials.gov) - P3 | N=312 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Intravenous Sirolimus Shows Tolerability, Early Efficacy in Malignant PEComa (OncLive) - P1/2 | N=54 | NCT05625919 | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | "At a data cutoff date of December 9, 2024, and with a median follow-up of 9.9 months, SRL-HSA elicited an objective response rate (ORR) of 34.1% (95% CI, 20.1%-50.6%) in all evaluable patients (n = 41). When broken down further, 2.4%, 31.7%, 31.7%, and 24.4% of patients achieved complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD), as their best overall response (BOR); 9.8% were not evaluable (NE). The disease control rate (DCR) was 65.9% (95% CI, 49.4%-79.9%)....'These data support phase 3 study to further explore the efficacy of SRL-HSA in patients with malignant PEComa,...'"

P1/2 data • Perivascular Epithelioid Cell Tumor

Shijiazhuang Pharmaceutical plans to include sirolimus injection in breakthrough therapy [Google translation] (bydrug.pharmcube.com) - "Shijiazhuang Pharmaceutical Group plans to include sirolimus for injection in the breakthrough therapy category. Today, the CDE official website showed that sirolimus for injection (albumin-bound) applied by Shijiazhuang Pharmaceutical Group is planned to be included in the breakthrough therapy category, and the indication is malignant perivascular epithelioid cell tumor. Perivascular epithelioid cell tumor (PEComa) is a rare type of sarcoma, and its source cell is unclear."

Breakthrough therapy • Perivascular Epithelioid Cell Tumor

SIROLIMUS FOR INJECTION (ALBUMIN-BOUND) WAS GRANTED BREAKTHROUGH THERAPY DESIGNATION IN CHINA (HKEXnews) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited (the 'Company', together with its subsidiaries, the 'Group') is pleased to announce that the Sirolimus for Injection (albumin-bound) (the 'Product') developed by the Group has been granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) of the People’s Republic of China for the intended indication of monotherapy for malignant perivascular epithelioid cell tumor (PEComa) (the 'Indication')."

Breakthrough therapy • Soft Tissue Sarcoma

A Study of Safety and Efficacy of Sirolimus for Injection (Albumin-bound) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumor (PEComa) (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor