Nanjing Rongjiekang Biotechnology Co., Ltd.'s independently developed innovative drug RJK-RT2831 recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation will facilitate access to relevant policy support for RJK-RT2831's subsequent research, development, registration, and commercialization in the United States, including research funding, tax breaks for clinical research expenses, exemption from prescription drug user fees, and accelerated market approval.

The Nanjing Rongjiekang RT2831 project is a bispecific nanobody drug targeting specific antigens on the surface of malignant hematological tumor cells. It has demonstrated excellent safety and efficacy potential in non-clinical studies. Currently, the project is undergoing Phase I clinical trials in China.

There remains a significant unmet medical need for patients with acute myeloid leukemia (AML), and RJK-RT2831 holds promise for providing AML patients with novel treatment options and greater clinical benefits. The FDA's orphan drug designation for RT2831 will facilitate the product's international clinical development and commercialization. We will accelerate clinical research to bring this product to AML patients worldwide as soon as possible.

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