Amgen's Etelcalcetide Approved in China for SHPT in Dialysis Patients, with Fosun Pharma Holding Commercial Rights

On May 9, the website of the National Medical Products Administration showed that Amgen's Etelcalcetide (Etelcalcetide, AMG 416) Injection has been approved for marketing. This is the first and only intravenous calcimimetic agent available in China. In May 2021, the Center for Drug Evaluation (CDE) accepted the marketing application for Etelcalcetide.

Etelcalcetide is a novel calcium-sensing receptor (CaSR) agonist/calcimimetic that enhances the sensitivity of CaSR to calcium ions by binding to human CaSR, inhibits the secretion of parathyroid hormone (PTH) by chief cells of the parathyroid gland, thereby reducing serum PTH levels. Etelcalcetide was approved for marketing by the EU and FDA in 2016 and 2017, respectively.Used to treat secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) undergoing hemodialysis, it has become the first entirely new therapy approved for this condition in over a decade.

SHPT is one of the common complications in CKD patients undergoing maintenance hemodialysis and is often chronic and compensatory in CKD patients. The incidence of SHPT in hemodialysis patients in China is 47%-58%. When renal function declines, factors such as hypocalcemia, hyperphosphatemia, and reduced active vitamin D stimulate parathyroid hyperplasia and excessive secretion of PTH, leading to a series of mineral bone metabolism disorders and severe clinical symptoms, including renal osteodystrophy, metastatic calcification, and cardiovascular and neurological damage.

According to the Rubik's Cube database, in May 2020, Amgen completed a multi-center, randomized, double-blind, double-dummy Phase III trial aimed at evaluating the efficacy and safety of intravenous Etelcalcetide compared to oral Cinacalcet hydrochloride in treating SHPT patients. Etelcalcetide and Cinacalcet have similar mechanisms of action but act on different sites; the former directly binds to the extracellular domain of CaSR, while the latter binds to the transmembrane domain of CaSR. The primary endpoint of the trial was the proportion of patients achieving a >30% reduction in mean pre-dialysis serum PTH levels from baseline during weeks 20-27 of the study.

Notably, another head-to-head study comparing Etelcalcetide with Cinacalcet has been successful. The results showed that among patients with moderate to severe SHPT undergoing hemodialysis,Etelcalcetide is non-inferior to Cinacalcet in reducing serum PTH concentrations over 20-27 weeks (68.2% vs 57.7%), meeting the primary endpoint of the study.Moreover, a higher proportion of patients in the Etelcalcetide group achieved a ≥50% reduction in PTH levels compared to the Cinacalcet group (52.4% vs 40.2%), reaching the secondary endpoint. Additionally, the safety and tolerability profiles were similar between the two groups.

June 2022,Fosun Pharma Announces Collaboration with Amgen on the Commercialization License of Etelcalcetide in China (excluding Hong Kong, Macao, and Taiwan)According to the agreement, Fosun Pharma USA, a subsidiary of Fosun Pharma, will pay up to US$47 million in upfront and regulatory milestone payments, and up to US$40 million in sales milestone payments to Kai Pharma, a subsidiary of Amgen.

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