CASI Pharmaceuticals - Evomela approved in China
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.CASI Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutics and pharmaceutical products. The company's primary product and candidates in hematology/oncology include: EVOMELA (Melphalan for Injection), an intravenous formulation of melphalan commercialized in the multiple myeloma treatment setting in the United States; CNCT19, which targets CD19, a B-cell surface protein expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies; CID-103, an investigational anti-CD38 monoclonal antibody being developed for the treatment of patients with multiple myeloma.
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