Shanghai, December 7, 2025 - WinHealth Pharma today announced that Orkedia® (evocalcet tablets), a new-generation oral calcimimetic, has been successfully included in the 2025 edition of China’s National Reimbursement Drug List (NRDL), following its official publication by the National Healthcare Security Administration and the Ministry of Human Resources and Social Security.
Orkedia® is a new-generation oral calcimimetic. In July 2024, it received approval from China’s National Medical Products Administration (NMPA) for the treatment of secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) patients undergoing maintenance dialysis. Orkedia® modulates the calcium-sensing receptor (CaSR) on parathyroid cells, thereby inhibiting parathyroid cell proliferation and suppressing parathyroid hormone (PTH) secretion1, which in turn reduces serum PTH levels.
SHPT is among the most common and serious complications in patients on maintenance hemodialysis, characterized by elevated PTH, parathyroid hyperplasia and hypertrophy, and disturbances in calcium-phosphorus mineral metabolism. Clinically, SHPT contributes to bone pain, fractures, and muscle weakness, and is closely associated with cardiovascular disease, vascular calcification, and neurological impairment2. In China, approximately 60% of maintenance dialysis patients exhibit SHPT to varying degrees, while the PTH target-achievement rate in these patients is only about 55%3. Published evidence indicates that SHPT is associated with a significantly increased risk of major adverse cardiovascular events (MACE) in patients with CKD, more than twofold versus those without SHPT4. Timely and effective control of SHPT is therefore one of the key measures to improve quality of life and survival outcomes in the dialysis population.
Jack Wang(Chairman of WinHealth Pharma)
"As a leading China-based comprehensive pharmaceutical enterprise specializing in the treatment of kidney and hematologic diseases, we remain committed to putting patients first. While introducing more innovative medicines to China, we align closely with national policies and advance multiple approaches to improve access and affordability so that innovation reaches a broader patient population. The inclusion of Orkedia® in the National Reimbursement Drug List within the first year of its commercial launch underscores our commitment to patients. We sincerely appreciate the robust measures advanced under China’s healthcare reform and will continue to proactively support the implementation of the updated NRDL to ensure more patients benefit from innovative therapies and standardized care, contributing to the high-quality development of China’s healthcare system."
Professor Ling Zhang(Chief Physician, Department of Nephrology, China-Japan Friendship Hospital)
“Having witnessed three generations of SHPT therapies, I believe there remains a clear unmet need for medicines that are effective, well tolerated, and convenient in routine clinical practice. Evocalcet tablets’ pharmacologic profile, characterized by high receptor sensitivity enabling low-dose administration, high target selectivity, and minimal drug interactions, addresses limitations of earlier approaches. Its efficacy and safety have been evaluated in multiple international, multicenter clinical studies. In our early clinical experience, many of my patients have achieved favorable therapeutic outcomes. With inclusion in China’s National Reimbursement Drug List, evocalcet tablets provides a new option that combines clinical efficacy with affordability and access, supporting standardized management of SHPT. It may enable millions of dialysis patients to access a well-tolerated and affordable treatment option that provides sustained reductions in PTH levels. I look forward to seeing its performance in clinical practice after NRDL inclusion, and to more innovative medicines benefiting patients with CKD.”
References：
1.Parfrey PS. Evocalcet in the management of secondary hyperparathyroidism in dialysis patients. Kidney Int. 2018 Oct.
2.Lau WL, et al. SHPT and mortality in dialysis patients. Clin J Am Soc Nephrol. 2018;13(6):952-961.
3.拟钙剂在慢性肾脏病患者中应用的专家共识[J]. 中华肾脏病杂志, 2018, 34(9): 703-708.
4.Xu Y,et al. Clin Kidney J. 2021 Jan 20;14(10):2213-2220. PMID: 34603697.