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7 March 2019

CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Registration Trial For MARQIBO®

In-licensed for the greater China region.
Marqibo® (vinCRIStine sulfate LIPOSOME injection) is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate, a microtubule inhibitor. Marqibo is approved by the FDA for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies.

Since MARQIBO is already approved in the U.S. and marketed by our licensor, we expect that gaining approval from local regulatory authorities for commercialization in greater China will require a shorter timeframe than clinical-stage drugs. CASI submitted an import drug registration is pending with CFDA.

Please see Marqibo 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, 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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