China Medical System (00867) Obtained Exclusive License of a First-line Phosphate-lowering Drug Velphoro®

SHENZHEN, CHINA – China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that on 2 February 2024, the Group through its wholly-owned subsidiary entered into a Novation Agreement (the “Novation Agreement”) with Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”) and Winhealth Investment (HK) Limited (“Winhealth Investment”) for sucroferric oxyhydroxide chewable tablets Velphoro^® (the “Product”).

Winhealth Investment and VFMCRP entered into a License Agreement (the “License Agreement”) for the Product on 28 June 2023. In accordance with the License Agreement, Winhealth Investment gained an exclusive license to register，import, promote, distribute, use and sell the Product in Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan Region (the “Territory”). The License Agreement commenced on its effective date and continues to be valid until the fifteenth anniversary of the date of the Product’s first commercial sale in the Territory. Upon the expiration of the aforementioned term, the License Agreement may automatically be renewed for ten years as per certain conditions defined in the License Agreement. Thereafter, unless the parties reach a new agreement, the License Agreement will terminate upon expiration.

In accordance with the Novation Agreement, Winhealth Investment novated its above-mentioned rights and obligations for the Product to a wholly-owned subsidiary of CMS.

Velphoro^® (Sucroferric Oxyhydroxide Chewable Tablets )

As of 2 February 2024, the Product is the first iron-based, non-calcium phosphate binder (PB) approved by National Medical Products Administration (NMPA) in China¹, filling 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. 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”). There is an issued patent that protects the formulation, usage, particle size and manufacturing methods of the Product in China.

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 patients². 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 safety⁵ and patient compliance⁶ without risk of calcium and heavy metal accumulation. In addition, the Product holds the advantages of unaffected absorption of oral liposoluble vitamin D⁷, maintaining stable iron parameters⁸, improving the nutritional status in patients⁹, reducing hospitalization rates, and alleviating patients’ medical financial burdens¹⁰. 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.

CMS continues to invest in and develop differentiated innovative products, providing a continuous source of momentum for the long-term and stable development of the Group. Velphoro^® is a newly approved innovative drug in China in 2023 and has been successfully included in category B of the National Reimbursement Drug List. It will rapidly expand the Group’s marketed innovative product portfolio and kidney disease product portfolio, and will synergize with the Group’s marketed products XinHuoSu (recombinant human brain natriuretic peptide for injection), Plendil (felodipine sustained-release tablets) and the innovative drug Desidustat tablets (intended to treat anemia in CKD patients) which is in the clinical development stage for registration in terms of expert network and market resources. It is expected to have a positive impact on the Group’s financial results.

More information about Hyperphosphatemia

The total number of CKD patients reaches 132 million in China, of which nearly 1 million existing patients receive dialysis treatments¹¹, 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 levels¹³. 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).

1. This news/article is intended to share cutting-edge medical information. It is only for reference by medical and health professionals for academic purposes and is not for advertising purposes; it does not recommend any drugs, medical devices and/or indications.

2. The information involved in this news/article is for reference only. Please follow the advice or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

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Source: China Medical System Holdings Ltd.