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, announced today that it has filed an application with China's Food and Drug Administration (CFDA) to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076. The China Phase 2 trial will be an extension of a U.S. Phase 2 trial that is expected to be initiated in the third quarter of this year.
Ken K. Ren, Ph.D., CASI's Chief Executive Officer, commented, "We are very pleased with the CFDA's acceptance of our application package and look forward to working with them to move the process towards approval. This is our fourth application to conduct a new drug clinical trial in China for ENMD-2076. We received approval for our first three applications to conduct trials in ovarian clear cell carcinoma, soft tissue sarcoma, and triple negative breast cancer (TNBC), the latter of which was initiated recently and is currently enrolling patients."
Dr. Ren further commented, "We continue to protect the proprietary nature of our unique drug candidate ENMD-2076. In addition to patents already issued in the U.S., China, Japan, Canada, and Australia among others, we have recently secured patent protection in Switzerland, Spain, Germany, France, U.K., Sweden, Korea and other territories. These recently issued patents add to our robust intellectual property portfolio."
SOURCE CASI Pharmaceuticals, Inc.