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19 February 2019

CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Confirmatory Clinical Trial For ZEVALIN®

In-licensed for the greater China region.

ZEVALIN® (Ibritumomab Tiuxetan). As part of our license transaction with Spectrum pursuant to which we acquired greater China rights to core product EVOMELA, we also acquired the greater China rights to FDA-approved ZEVALIN. ZEVALIN is a CD20-directed radiotherapeutic antibody indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL). The ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) a beta-emitting radioisotope. On February 12, 2019 the Company received NMPA’s approval of the Company’s Clinical Trial Application (CTA) to allow for a confirmatory registration trial to evaluate the drug’s efficacy and safety.

Clinical Development Status

CASI intends to advance the development, import drug registration, and market approval of this product in China, and expects the registration study to be initiated by early 2021.

Please see Zevalin product and safety information.

About Us

CASI is a U.S. NASDAQ-listed biopharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, the U.S., and throughout the world. We have offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China, through which substantially all of our operations are conducted.

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