China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its sirolimus (albumin-bound) as a monotherapy for malignant perivascular epithelioid cell tumor (PEComa).
Drug Profile
Sirolimus, also known as rapamycin, is a commonly used specific mTOR inhibitor. Oral sirolimus is already approved for preventing organ rejection in kidney transplant patients. The product has shown superior efficacy as a single agent in clinical data and is currently subject to multiple Phase II and III clinical studies in China for various solid tumors and hematomas, including breast cancer, soft tissue sarcoma, lung cancer, and kidney cancer.
Clinical Need
There is currently no standard therapy for malignant PEComa in China, indicating significant unmet clinical needs. The BTD granted to CSPC Pharmaceutical’s sirolimus highlights the potential of the drug to address this gap in treatment options.-Fineline Info & Tech
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