CASI is a biopharmaceutical company focused on the acquisition, development, and commercialization of innovative therapeutics addressing CANCER and other unmet medical needs for the global market, with a focus on China and the U.S. We are a NASDAQ-listed company, headquartered in Rockville, Maryland with a wholly owned subsidiary and R&D operations in Beijing, China.
Our mission is to become an integrated biopharmaceutical company with significant market share in China, while establishing partnerships for global development and commercialization. Part of our strategy is to leverage our expertise and resources in North America and China to bring safer, more effective, and/or easier-to-use drugs to patients and to develop them more cost-effectively and faster using our unique dual development approach.
We have a strong and growing product pipeline, and will continue to (i) seek to acquire additional drug candidates through in-license and acquisitions, and (ii) explore drug candidates in preclinical development.
Our pipeline includes our proprietary ENMD-2076, a selective angiogenic kinase inhibitor currently in multiple Phase 2 oncology studies, and 2ME2 (2-methoxyestradial) an orally active compound that has antiproliferative, antiangiogenic and anit-inflammatory properties. ENMD-2076 has received Orphan Drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia and hepatocellular carcinoma, and orphan drug designation from the EU for the treatment of hepatocellular carcinoma (HCC) including fibrolamellar carcinoma (FLC).
We have exclusive rights in China (including Taiwan, Hong Kong and Macau) to three in-licensed oncology products, including MARQIBO® (vinCRIStine sulfate LIPOSOME injection) approved in the U.S. for advanced adult Ph- acute lymphoblastic leukemia (ALL), ZEVALIN® (ibritumomab tiuxetan) approved in the U.S. for advanced non-Hodgkin’s lymphoma, and EVOMELA® (melphalan) for Injection which received FDA NDA approval in March 2016. We have initiated the development and regulatory process to obtain marketing approval for these products in our territorial region.