CFDA approves ENMD-2076 Phase II CASI trial in breast cancer patients with triple negative -
CASI Pharmaceuticals, Inc. ( Nasdaq: CASI), a pharmaceutical company developing clinical stage therapies for the treatment of cancer and other diseases, today announced that the Food and Drug administration of China (CFDA) approved the company's request to conduct a clinical phase II trial in breast cancer triple negative (CSTN) patients China for its own drug candidate, ENMD-2076.
Ken K. Ren, Ph.D., CEO of CASI, commented, "CFDA approval of our application is an important and exciting step for CASI in the execution of our China and the global strategy of integrated development. TNBC our Phase II trial ENMD-2076 in the uS is on track, and we can now extend the trial in China by recruiting more patients. test data China can be combined with the data being collected in the United States, and may lead to achieve a clinical inflection point faster. in addition, China's trial will allow us to evaluate the safety and efficacy of ENMD-2076 in the Chinese population of the patient, providing the ability to meet unmet medical needs in the country. in addition, this test data can be used to support our drug registration import in China . the future "
Dr. Ren continued," our development team in Beijing works closely with our principal researcher and key opinion leaders from major oncology centers in China in preparation for the trial. We intend to conduct additional tests, it is an important part of our overall China strategy and integrated development for the development of cost-effective drugs, and to achieve our mission to make drugs safer and more efficient for patients. We look forward to the continued advancement of ENMD-2076. "
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