Kind Pharmaceutical ("Hangzhou Andao Pharmaceutical Ltd. and Kind Pharmaceuticals LLC"), a clinical-stage biopharmaceutical company focused on developing innovative medicines to treat hematological diseases and cancers,  announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to AND017 in the treatment of Sickle Cell Disease (SCD). AND017 is being developed to treat various anemia indications associated with diseases including non-dialysis dependent chronic kidney disease (NDD-CKD) and dialysis-dependent chronic kidney disease (DD-CKD). The results for AND017's phase 1 in healthy subjects and phase 2 clinical trials in treatment of anemia in NDD-CKD and anemia in DD-CKD are currently being presented at the annual meeting of American Society of Nephrology (ASN) Kidney Week in San Diego. The preclinical work supporting AND017's ODD in SCD will be presented in future scientific meeting and subsequently published in a scientific journal.

Sickle Cell Disease (SCD) is a devasting genetic disease with US patient population around 120,000; SCD disproportionally affects Black and African Americans, comprising more than 98% of patients living with this disease. "The FDA's granting of ODD for AND017 underscores the urgent medical need for new therapies, particularly oral drugs to safely and effectively treat patients with SCD," said Dong Liu, Ph.D., Founder, Chairman, and CEO of Kind Pharmaceutical. "The granting of ODD also demonstrates the innovation capability and the vision of Kind Pharmaceutical."

"Hydroxyurea and L-glutamine are the limited FDA-approved oral treatments for SCD, AND017 from Kind Pharmaceutical might not only provide a novel oral treatment with unique mechanism of action, but also an obvious better safety and efficacy profile." said Prof. Gang Huang at UT Health San Antonio, Kathryn Mays Johnson Distinguished Chair in Oncology, who is an expert in studies of hematology and various blood diseases, and involved in the preclinical studies of AND017 in SCD. "I am eager to see how a compound with such unbelievable preclinical safety and efficacy data will translate to real world SCD patients."

FDA Orphan Drug Designation (ODD) is granted to a drug or biological product to prevent, diagnose or treat a rare disease or condition that affects fewer than 200,000 people in the United States. ODD qualifies KIND for incentives including tax credit for qualified clinical trials, exemption from user fees, and potential seven years of market exclusivity after AND017's approval for treatment of Sickle Cell Disease (SCD).