CSPC Pharmaceutical Group's (HKG:1093) Sirolimus for Injection has been granted breakthrough therapy designation by China's National Medical Products Administration for the intended indication of monotherapy for malignant perivascular epithelioid cell tumor, a Feb. 28 bourse filing said.
The oral formulation of sirolimus previously approved for marketing is primarily indicated for the prevention of organ rejection in kidney transplant patients.
Sirolimus is currently undergoing multiple phase II and III clinical studies in China for the treatment of solid and hematological tumors.
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