CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and other diseases, announced today that China's Food and Drug Administration (CFDA) has approved the Company's application to conduct a Phase II clinical trial in triple-negative breast cancer (TNBC) patients in China for its proprietary drug candidate, ENMD-2076.
Ken K. Ren, Ph.D., CASI's Chief Executive Officer, commented, "CFDA's approval of our application represents a significant and exciting milestone for CASI in the execution of our China and global integrated development strategy. Our Phase II TNBC trial of ENMD-2076 in the U.S. is progressing as planned, and we can now further expand the trial into China with the recruitment of more patients. Data from the China trial can be combined with data being collected in the U.S., and may lead to reaching a clinical inflection point faster. In addition, the China trial will enable us to evaluate the safety and efficacy of ENMD-2076 in the Chinese patient population, providing an opportunity to address unmet medical needs in the country. Furthermore, data from this trial may be used to support our import drug registration in China in the future."
Dr. Ren continued, "Our development team in Beijing is working closely with our principal investigator and key opinion leaders from leading oncology centers in China in preparation for the trial. We intend to conduct additional trials there as an important component of our China and global integrated development strategy for cost-effective drug development, and to deliver on our mission to bring safer and more effective medicines to patients. We look forward to the continued advancement of ENMD-2076."
CASI Pharmaceuticals, Inc.