CASI Pharmaceuticals Inc. said China's National Medical Products Administration approved its blood cancer medicine Evomela.
Evomela, or melphalan hydrochloride, was approved as a high-dose conditioning treatment before stem cell transplant in patients with multiple myeloma. The injection is also indicated as a palliative care therapy for multiple myeloma patients who cannot be treated with oral therapy.
Multiple myeloma is a cancer that begins in a type of white blood cells known as plasma cells. In multiple myeloma, the cancer cells accumulate in the bone marrow and form tumors in many bones of the body.
The approval was granted under the Chinese health authority's new priority review guidelines. The Chinese regulators also required a post approval confirmatory study, CASI noted.
CASI Pharmaceuticals acquired rights to Evomela for greater China, including Taiwan, Hong Kong and Macau, from Spectrum Pharmaceuticals Inc. in 2014.
Rockville, Md.-based CASI Pharmaceuticals develops and commercializes pharmaceuticals and therapeutics for treating cancer and other unmet medical needs, with a focus on greater China and U.S.