Hansoh Pharmaceutical's Imported Class 1 New Drug HS-10568 (SHR6508) Receives NDA Acceptance for Secondary Hyperparathyroidism in Dialysis CKD Patients
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
On June 10, according to the official website of the CDE,Hansoh Pharma（Jiangsu SubsidiaryHansoh Pharmaceutical Group）Introduced Innovative DrugsHS-10568（SHR6508） The submitted marketing application has been accepted.This drug is a CaSR allosteric modulator for the treatment of secondary hyperparathyroidism in chronic kidney disease patients undergoing dialysis.December 2025,Hansoh PharmaandHengrui PharmaSecured licensing collaboration to obtain the rights for this drug in mainland China(Excluding Hong Kong, Macao, and Taiwan)all rights to the development, manufacturing, and commercialization.
HS-10568For the calcium-sensing receptor（CaSR）Allosteric modulators inhibit parathyroid hormone by enhancing receptor sensitivity to extracellular calcium ions（PTH）Secretion, primarily used for the treatment of chronic kidney disease in hemodialysis（CKD）Secondary Hyperparathyroidism（SHPT）. The results of the Phase II clinical study SHR6508-201 showed that, in dialysis patients with SHPT, at Week 16 of treatment, patients in the HS-10568 slow-titration group and fast-titration group had intact parathyroid hormone（iPTH）The reductions reached62.7%、61.7%, significantly superior to the 38.9% observed in the cinacalcet control group（P<0.05）。
Screenshot source: Global Drug R&D Database (ClickMini ProgramView More)
Regarding safety data, treatment-related adverse events in the three groups（TRAE）The incidence rates were similar, at 83.3%, 83.3%, and 86.7%, respectively; furthermore, adverse reactions in both HS-10568 groups were mild to moderate in severity, with significantly lower incidences of nausea and vomiting compared to the cinacalcet group, demonstrating a superior safety profile.
According to data from Mosu Pharma, currentlyGlobalA total of four CaSR-targeted drugs have been approved for marketing, among which onlyUpasitaAs a CaSR allosteric modulator,This drug is in ChinaPhase I Clinical Stage。
Screenshot source: Global Drug R&D Database (ClickMini ProgramSee More)
The Phase III clinical trial SHR6508-301 of this product completed the enrollment of the first patient in June 2024, and the trial status was updated to “completed” in November 2025. Detailed data have not yet been publicly disclosed.
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