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ZEVALIN®

Zevalin

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) injection for intravenous use is a CD20-directed radiotherapeutic antibody. It is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL). ZEVALIN is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin’s Lymphoma who achieve a partial or complete response to first-line chemotherapy.

ZEVALIN therapeutic regimen consists of two components: rituximab, and Yttrium-90 (Y-90) radiolabeled ZEVALIN for therapy. ZEVALIN builds on the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic effects of a beta-emitting radioisotope. Please see www.zevalin.com for ZEVALIN product and safety information.

Since ZEVALIN is already approved in the U.S. and marketed by our licensor, CASI expects that gaining approval from local regulatory authorities for commercialization in greater China will require a shorter timeframe than clinical-stage drugs. ZEVALIN is now available in Hong Kong.

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, 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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