Marqibo® 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. Please see Marqibo product and safety information.
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. We submitted an import drug registration is pending with CFDA.