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

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