Salubris Pharmaceuticals' Enarocapt gets expanded approval for CKD anemia

Shenzhen Salubris Pharmaceuticals Co., Ltd. recently announced it has received a drug registration certificate from the National Medical Products Administration for Enarodustat tablets (Enarocapt®). The new approval expands the drug's indications to include the treatment of anemia in adult patients with chronic kidney disease (CKD), encompassing both dialysis (hemodialysis and peritoneal dialysis) and non-dialysis patients. The drug is available in 1mg, 2mg, and 4mg dosages.

Enarocapt®, a HIF-PHI drug, was initially approved in 2023 for non-dialysis adult CKD patients and was included in the national medical insurance directory the same year. This latest approval broadens its application to a wider patient population suffering from renal anemia, a common CKD complication that significantly impacts quality of life and increases cardiovascular risks.

The company states that this new indication is expected to positively impact its future performance and long-term development. Salubris Pharmaceuticals is also conducting clinical trials for other indications of Enarocapt, including anemia caused by chemotherapy in non-myeloid malignant tumor patients (CIA), with some studies currently in Phase II.