Registration Application For MARQIBO® Accepted For Review By CFDA
CASI Pharmaceuticals’ Import Drug Registration Application For MARQIBO® Accepted For Review By CFDA
ROCKVILLE, Md., Jan. 12, 2016 - CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that China’s Food and Drug Administration (CFDA) has accepted for review its import drug registration application for MARQIBO® (vinCRIStine sulfate LIPOSOME injection).
CASI’s China rights to MARQIBO was licensed from its partner Spectrum Pharmaceuticals, Inc. MARQIBO is the first and only liposome-encapsulated vincristine approved and currently marketed in the U.S. for second line treatment of adult Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL). CASI’s filing with the CFDA is an important milestone step to expand the availability of the treatment to patients in China. Annual incidence of leukemia in China is estimated at 70,240 cases with a mortality of 58,746 cases in 2015. The five-year prevalence in the country is estimated at 73,694 cases including about 10,000 Ph- adult ALL, representing a serious, unmet medical need.
Ken Ren, Ph.D, CASI’s Chief Executive Officer, commented, “We are very pleased with CFDA’s decision and look forward to working with the agency to move the process forward towards market approval. As part of the market approval process, we expect to conduct a confirmatory trial in China. MARQIBO is also being developed in two Phase 3 studies in other indications, including non-Hodgkin’s lymphoma. We are working expeditiously to reach market approval in China for MARQIBO to treat adult Philadelphia chromosome-negative (Ph-) ALL, as well as for additional indications that may later come on board.”
About CASI Pharmaceuticals, Inc.
CASI is a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China. CASI’s product pipeline includes exclusive rights to ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vinCRIStine sulfate LIPOSOME injection) and EVOMELA™ (CE-Melphalan HCI for injection) for the greater China market (including Taiwan, Hong Kong and Macau). CASI’s development pipeline also includes its proprietary drug candidate ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) currently under reformulation development. CASI is headquartered in Rockville, Maryland and has a wholly owned subsidiary and R&D operations in Beijing, China. More information on CASI is available atwww.casipharmaceuticals.com and in the Company’s filings with the U.S. Securities and Exchange Commission.
About Marqibo®
Marqibo is a novel, sphingomyelin/cholesterol liposome-encapsulated formulation of vincristine sulfate. Vincristine, a microtubule inhibitor, is FDA approved 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. The encapsulation technology, utilized in this formulation, has been shown to provide prolonged circulation of vincristine in the blood. Marqibo is not yet available in China; more information on Marqibo for countries outside the greater China region is available at www.sppirx.com
