China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the National Medical Products Administration (NMPA) for enarodustat, a novel drug candidate specifically targeting renal anemia. Enarodustat is a hypoxia-inducible factor proline hydroxylase inhibitor (HIF-PHI) developed for anemia in non-dialysis adult chronic kidney disease (CKD) patients.
Salubris’ Licensing Deal and Enarodustat’s Benefits
Salubris struck a licensing deal with Japan Tobacco Inc. in December 2019, obtaining exclusive rights to the drug for renal anemia in China. The drug’s regulation of HIF targets is considered more reasonable and appropriate, stimulating endogenous erythropoietin (EPO) closer to physiological concentrations. This results in a steady and controlled increase in hemoglobin levels, boasting good overall safety. Enarodustat’s once-daily oral administration enhances patient treatment adherence, without the need for weight-based dosage adjustments and with a low risk of drug interactions.
Market Competition and Reimbursement
AstraZeneca’s roxadustat is currently the only HIF-PHI approved in China and entered the National Reimbursement Drug List (NRDL) in 2019. With the approval of enarodustat, Salubris Pharmaceuticals is set to compete in the renal anemia treatment market, offering an additional treatment option for patients and potentially impacting the dynamics of the HIF-PHI drug market in China.-Fineline Info & Tech
