Casi Pharma (NASDAQ:CASI) announced that it has received approval in China for Evomela. The drug is a formulation of melphalan hydrochloride used in the treatment of multiple myeloma, and CASI obtained the rights to the drug in Greater China from its original developer, Spectrum Pharmaceuticals, in 2014. This put CASI in a unique position to take advantage of the regulatory reforms in China. The drug was approved under the new priority review pathway at the National Medical Products Administration (NMPA, formerly the CFDA) and serves as a test case for this new regulatory regime.
Approved for the same indications as in the US
Evomela was approved by the NMPA for the use as a conditioning agent prior to stem cell transplant and for palliative treatment for multiple myeloma patients who cannot take oral drugs, with the former being the primary commercial driver. Conditioning is the treatment of a patient with high doses of chemotherapy to remove their native stem cells (and cancer) prior to replacement with a transplant, and is common in the treatment of multiple myeloma. The drug is approved for the same indications in the US, and Spectrum reported sales of $6.8m for Q318.
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