On 6 February, first-line phosphate-lowering Drug Velphoro® (sucroferric oxyhydroxide chewable tablets) has been issued its first prescription in the Gansu Provincial Hospital, which marks that the first iron-based, non-calcium phosphate binder (PB) approved by National Medical Products Administration (NMPA) in China[1] has officially entered clinical application. Velphoro® has become a new option of phosphorus-lowering treatment for CKD dialysis patients in China, and filled the gap of phosphorus-lowering treatment for Chinese paediatric patients aged 12 to 18 years old with CKD stages 4-5 or CKD on dialysis.
Velphoro® is a Class 5.1 imported innovative drug, which was approved through the priority review and approval procedure in China in February 2023 for the control of serum phosphorus (sP) levels in adults with chronic kidney disease (CKD) on hemodialysis (HD) or peritoneal dialysis (PD), and meanwhile, for the control of sP levels in paediatric patients 12 years of age and older with CKD stages 4-5 (defined as glomerular filtration rate <30mL/min/1.73 m²) or CKD on dialysis. In December 2023, the Product has been newly included in category B of China’s National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2023 Version) (the “National Reimbursement Drug List”).
Various business departments of CMS worked together to maximize the integration of internal and external resources, and actively cooperated to promote the implementation and admission of medical insurance of Velphoro®, thus achieving the issue of the first-prescription of Velphoro®, and benefiting the vast number of patients with relevant indications.
Gansu Provincial Hospital issued the first prescription of Velphoro® (sucroferric oxyhydroxide chewable tablets)
Hyperphosphatemia is a common complication in CKD patients, especially in patients with end-stage renal disease on dialysis, characterized by a high morbidity and a low compliance rate. It is an independent risk factor for nephropathy progression, secondary hyperparathyroidism, cardiovascular events and all-cause mortality in CKD patients[2]. Controlling sP levels can significantly improve the outcomes of CKD patients.
Since non-calcium PB has no risk of vascular calcification, domestic and foreign guidelines consistently recommend non-calcium PB as first-line treatment for reducing sP levels, and limit the use of calcium-based PB. Velphoro® is a new generation of iron-based, non-calcium PB, reducing sP levels of patients and increasing the sP compliance rate. Velphoro® has been launched in 51 countries/territories including the US, EU and Japan, maintaining a leading position in the global PB market.
It is demonstrated in multiple global clinical studies and real-world research data (as published in academic journals including International Urology and Nephrology, and Clinical Nephrology) and the Chinese instruction of the Product that compared with other PBs, patients maintained on Velphoro® used about 50% fewer PB pills/day[3], and the proportion of patients achieving target sP increased by 95%[4]. Velphoro® has characteristics of good safety[5] and patient compliance[6] without risk of calcium and heavy metal accumulation. In addition, the Product holds the advantages of unaffected absorption of oral liposoluble vitamin D[7], maintaining stable iron parameters[8], improving the nutritional status in patients[9], reducing hospitalization rates, and alleviating patients’ medical financial burdens[10]. Velphoro® is expected to further improve the dialysis patients’ quality of life and become a new option of phosphorus-lowering treatment for CKD dialysis patients in China.
Velphoro® (sucroferric oxyhydroxide chewable tablets)
Mr. Jiang Qingfu, General Manager of Cardio-cerebrovascular/ Gastroenterology Business (CMS Shenzhen), said that, “We are very glad to see that the first prescription of Velphoro® has been officially issued, benefiting more CKD patients with hyperphosphatemia in China. With the continuous increase of CKD patients in China, a large number of clinical needs urgently need to be met. CMS is a patient-oriented company and focuses on improving the accessibility of innovative drugs. As Velphoro® has successfully entered into large scale clinical application, we will continue to improve the product accessibility through an efficient commercialization team. We hope to further improve the quality of life and outcomes of CKD patients with hyperphosphatemia in the future, escorting the health of patients with relevant indications.”
Since 2023, CMS’s four innovative drugs have successfully approved for marketing and officially entered the national scale clinical application, demonstrating the mature drug commercialization capability and efficient execution of the company, and marking that the company has entered into a new stage of the innovative products commercialization. In the future, CMS will stay true to its original aspiration, strive to meet the unmet needs of Chinese patients, continuously explore novel and good drugs with international quality, and efficiently promote product clinical development and commercialization, contributing to safeguard the life quality of patients.
More information about Hyperphosphatemia
The total number of CKD patients reaches 132 million in China, of which nearly 1 million existing patients receive dialysis treatments[11], and continues to increase at a rate of approximately 10% per year. The prevalence of hyperphosphatemia reaches 72.1%[12] in CKD patients on dialysis, and nearly 50% of dialysis patients need to receive oral PB to control sP levels[13]. According to the survey in Chinese patients with chronic kidney disease-mineral and bone disorder, combined with real-world findings, on the basis of existing phosphate-lowering treatments, the sP compliance rate of CKD dialysis patients in China is only 24.3%[14]. The low sP compliance rate is currently the clinical pain point of hyperphosphatemia, and there is an urgent need for more potent drugs with lower pill burden and better adherence to satisfy the clinical treatment demand of hyperphosphatemia.
Reference：
1.Drug registration information can be found on the NMPA official website, as follows: https://www.nmpa.gov.cn/datasearch/search-result.html
Or can be found in the public medical insurance materials, as follows：http://www.nhsa.gov.cn/attach/Ypsn2023/YPSW202300180/YPSW202300180-W1(ppt).pdf
2.XQ Yu, et al. Chin J Nephrol, 2018. 34(11): 867-871
3.The Instructions for Sucrose HydroxyIron Oxide Chewable Tablets
4.Coyne DW, et al. Clin Nephrol. 2017 Aug;88(8):59-67.
5.Xie, D., Ye, N. & Li, M., Int Urol Nephrol 50, 905-909 (2018)
6.Floege J, et al. Nephrol Dial Transplant. 2015 Jun;30(6):1037-46
7.Sprague SM,et al.Am J Nephrol. 2016;44(2)104-12
8.Vervloet MG et al. Clin Kidney J 2021;14:1770-9
9.Kalantar-Zadeh K, et al. BMC Nephrol . 2019 0ct 29;20(1):396
10.Kidney Med. 2020 May-Jun; 2(3): 307-316
11.The data of China’s CNRDS reported by academician, Meixiang Chen., on 2023 Annual Conference of Chinese Nephrologist Association.
12.YF Chen, et al. Chin J Blood Purif. 2022; 21(05): 305-308.
13.Kidney International Supplements, 2020, 10(2): e97–185
14.Hong, D. et al. Sci Rep 12, 16694 (2022).
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