RegeneCore's Bispecific Antibody Drug RT2831 Granted Orphan Drug Designation by U.S. FDA
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- Time of issue:2026-01-07
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RegeneCore's Bispecific Antibody Drug RT2831 Granted Orphan Drug Designation by U.S. FDA
(Summary description)RJK-RT2831, an innovative drug independently developed by Nanjing RegeneCore Biotech Co., Ltd., has recently been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation will facilitate the drug's subsequent research, development, registration, and commercialization in the United States by providing various policy supports, including R&D funding, tax credits for clinical trial expenses, exemption from prescription drug user fees, and accelerated marketing review and approval.
- Categories:News
- Author:
- Origin:
- Time of issue:2026-01-07
- Views:403
RJK-RT2831, an innovative drug independently developed by Nanjing RegeneCore Biotech Co., Ltd., has recently been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML). This designation will facilitate the drug's subsequent research, development, registration, and commercialization in the United States by providing various policy supports, including R&D funding, tax credits for clinical trial expenses, exemption from prescription drug user fees, and accelerated marketing review and approval.
The RT2831 project of Nanjing RegeneCore Biotech Co., Ltd. is a bispecific nanobody drug that targets specific antigens on the surface of malignant hematological tumor cells. It has demonstrated excellent safety and efficacy potential in non-clinical studies. Currently, a Phase I clinical trial for this project is underway in China.
There is still a significant unmet medical need for patients with acute myeloid leukemia (AML). RJK-RT2831 is expected to provide AML patients with a novel treatment option and greater clinical benefits. The FDA's Orphan Drug Designation for RT2831 will accelerate the product's global clinical development and commercialization process. We will accelerate the pace of clinical research to bring this product to AML patients worldwide as soon as possible.
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