Recently, Salubris announced that Enaroy® (Enarodustat Tablets) has received approval from the National Medical Products Administration (NMPA) for its new additional indication in treating anemia in dialysis patients with chronic kidney disease (CKD)[1].
Renal anemia is one of the most common complications in CKD patients, not only significantly impairing their quality of life but also markedly increasing the risks of cardiovascular events and mortality. As renal function declines, the prevalence of anemia in CKD patients gradually rises and its severity progressively worsens[2].
Enaroy® (Enarodustat Tablets) is a new-generation hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) drug launched domestically in China. It was approved in 2023 for treating anemia in non-dialysis adult patients with chronic kidney disease (CKD) and was included in the National Reimbursement Drug List in the same year. The newly approved indication is for treating anemia in dialysis-dependent CKD patients (hereinafter collectively referred to as "renal anemia").
PHD1 enzyme, enabling more rational and moderate regulation of the HIF pathway. It promotes the production of endogenous erythropoietin (EPO) that closely mirrors physiological concentrations, demonstrates superior trends in iron metabolism improvement, and effectively elevates hemoglobin (Hb) levels with high efficacy and stability[3]. Following the market approval of this new indication, Enaroy® will provide a novel treatment option for more patients with renal anemia, thereby better addressing the unmet clinical needs in this therapeutic area.
Additionally, the company has also been conducting clinical studies on additional indications for Enaroy® (Enarodustat Tablets), including the treatment of chemotherapy-induced anemia (CIA) in patients with non-myeloid malignancies. These studies are currently at various stages of research, including Phase II clinical trials.
About Renal Anemia
"Renal anemia refers to anemia caused by absolute or relative insufficient production of erythropoietin (EPO) due to various kidney diseases, combined with the impact of uremic toxins on red blood cell production and survival. The Chinese Clinical Practice Guidelines for Diagnosis and Treatment of Renal Anemia (2021) indicate that HIF-PHI represents a novel class of small-molecule oral drugs for treating renal anemia. The oral formulation significantly enhances medication convenience for patients, offering a entirely new therapeutic option for those with renal anemia."
References:
[1] Announcement of Shenzhen Salubris Pharmaceuticals Co., Ltd. on Obtaining Drug Registration Certificate for the New Additional Indication of Enaroy® (Enarodustat Tablets)
[2] Chinese Clinical Practice Guidelines for Diagnosis and Treatment of Renal Anemia (2021)
[3] Phase Ⅲ Clinical Trial Results and Drug Package Insert
Disclaimer:
1. This material is intended to provide knowledge in the field of disease, enhance disease awareness, and is not for promotional purposes.
2. The information contained herein is for reference only. Please follow the advice or guidance of physicians or other healthcare professionals.
About Salubris
Shenzhen Salubris Pharmaceuticals Co., Ltd., founded in 1998, is an innovation-driven pharmaceutical listed company (Stock Code: 002294) with integrated R&D, production, and marketing operations, rooted in China and serving the global market. With the mission of "providing exceptional pharmaceutical products for human health," Salubris has deepened its expertise in chronic disease treatment with a focus on cardiovascular and cerebrovascular conditions. The company has successfully commercialized alisartan monotherapy, combination drugs, and co-crystal formulations to address diverse complex hypertension challenges, establishing a unique family of first-in-class antihypertensive therapies centered on alisartan.
Salubris has established five innovative drug R&D centers and three medical device R&D bases globally, creating innovation platforms focused on small molecule drugs, biological drugs, siRNA therapeutics, gene-editing therapies, and medical devices. The company is committed to developing innovative products that address unmet clinical needs, with the goal of enhancing people's quality of life and extending healthy lifespan.
