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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). As part of our license transaction with Spectrum pursuant to which we acquired greater China rights to our core product EVOMELA, we also acquired the greater China rights to MARQIBO. MARQIBO is a novel, sphingomyelin/cholesterol liposome-encapsulated, formulation of vincristine sulfate, a microtubule inhibitor, 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. In March 2019, the Company received NMPA’s approval of the Company’s Clinical Trial Application (CTA) to allow for a trial to evaluate its efficacy and safety. However, due to the evolving standard of care environment, the rare and niche indication for this product, and our commitment to prioritize resources for our other programs, the Company considers this product to be non-core and is currently evaluating its options for this product.

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, 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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