Jul 20 2015
CASI Pharmaceuticals, Inc. (Nasdaq: 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, announces that ZEVALIN®is now available at hospitals in Hong Kong to patients with indicated non-Hodgkin's lymphoma (NHL), including at Hong Kong Sanatorium & Hospital. The drug will be supplied by CASI and its local partner, Global Medical Solutions Hong Kong Limited.
ZEVALIN (ibritumomab tiuxetan) is a FDA-approved product indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). It is also indicated for the treatment of patients with previously untreated follicular non-Hodgkin's Lymphoma who achieve a partial or complete response to first-line chemotherapy. ZEVALIN builds on the combined therapeutic effects of a targeted biologic monoclonal antibody augmented with a beta-emitting radioisotope. CASI Pharmaceuticals holds the exclusive marketing rights to ZEVALIN in greater China (including Taiwan, Hong Kong and Macau) and is launching the drug in Hong Kong as the first of its marketing territories.
Rong Chen, M.D., CASI's Chief Medical Officer, commented, "We are very pleased that we can now provide ZEVALIN in Hong Kong hospitals and help address the unmet medical needs there. ZEVALIN is clinically proven to have significantly higher complete response rate (CR) and overall response rate (ORR) in relapsed or refractory, low-grade or follicular B-cell NHL patients in comparison with rituximab. It is also clinically proven to be efficacious with quite high CR and ORR in patients who are not responding or relapsed from rituximab therapy.
"We are very excited to work with Hong Kong Sanatorium & Hospital to make ZEVALIN available to patients," said Ken K. Ren, Ph.D., Chief Executive Officer of CASI Pharmaceuticals. "It is one of the leading private hospitals in Hong Kong known for its high quality of patient care based on advanced knowledge, expertise and technology in the healthcare field. Although Hong Kong is a relatively small market, it is strategically important as it will enable us to gain clinical knowledge and experience for ZEVALIN in a Chinese patient population, which we believe will have positive impact in market penetration when ZEVALIN is approved and becomes available in our greater China markets."
Dr. Ren continued, "CASI is on track to file its import drug registration application for ZEVALIN with the Chinese FDA by the third quarter of this year, followed by the filing of its marketing application and initiation of commercial activities for ZEVALIN in Taiwan. In addition to ZEVALIN, the Company has exclusive marketing rights in greater China to MARQIBO® and EVOMELA™ (CE-Melphalan HCl) for injection both also acquired from our partner Spectrum Pharmaceuticals. We are also on track to have our import drug registration application for MARQIBO filed with the Chinese FDA by the third quarter of this year, and plan to file the import drug registration application for EVOMELA once our partner receives FDA NDA approval in the U.S. We continue to pursue our goal of reaching the earliest possible launch and market penetration in China and our other markets for all our late-stage products."
CASI Pharmaceuticals, Inc.