China's First Sevelamer Carbonate Oral Suspension Approved: Joincare and Anyuan Biopharma Enhance CKD Treatment Accessibility
January26Day,National Medical Products Administration (NMPA Official WebsitePublic Notice,byHangzhou Anprime Biopharma Co.,Ltd (hereinafter referred to as“Anprime Biopharma”) for R&D and production, with exclusive commercialization by a subsidiary of Zhiyun Healthof sevelamer carbonate for dry suspension obtainedNMPA registration approval, deemed to have passed the generic drug consistency evaluation.This isDomesticThe first recipient ofBatch of sevelamer carbonate for dry suspension.
Zhiyun Health will leverage its hospital SaaS coverage network and digital capabilities to collaborate on the digital marketing promotion and sales of sevelamer carbonate for oral suspension. This partnership will expand the product’s market reach, enhance promotional efficiency, and benefit more patients.
Hangzhou Anprime Biopharma Co.,Ltd, established in 2016, is a specialized pharmaceutical company primarily engaged in the research and development of innovative polymer-based drugs and generic drugs with high technical barriers. The therapeutic areas of its R&D pipeline mainly include nephrology, hepatobiliary diseases, cardiovascular diseases, and gastrointestinal disorders. Its primary target markets include China, the United States, and other regulated markets.
Hyperphosphatemia is a common complication in patients with chronic kidney disease (CKD), affecting nearly all patients with end-stage renal disease (ESRD). According to the latest epidemiological data, the population of CKD patients in China exceeds 132 million, among whom the number of patients with ESRD reaches 3.536 million.
In addition to triggering secondary hyperparathyroidism (SHPT) and chronic kidney disease–mineral and bone disorder (CKD-MBD), long-term hyperphosphatemia is also associated with ventricular hypertrophy and calcification of the myocardium, blood vessels, and soft tissues. It has been confirmed by multiple studies as an independent risk factor for cardiovascular mortality.
Management of serum phosphorus in patients with chronic kidney disease (CKD) primarily relies on individualized dietary phosphate restriction, dialysis, and pharmacological therapy. Among pharmacological interventions, phosphate binders are the most widely used phosphorus-lowering agents, as they effectively reduce serum phosphorus levels in CKD patients by decreasing gastrointestinal phosphate absorption.
Sevelamer carbonate is a novel, calcium-free phosphate binder that reduces phosphorus absorption by binding to phosphorus in the gastrointestinal tract. It is widely used in clinical practice for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are undergoing dialysis, as well as in adult CKD patients not on dialysis who have serum phosphorus levels greater than or equal to 1.78 mmol/L.
Compared with metal-containing phosphate binders such as aluminum hydroxide and calcium carbonate, sevelamer carbonate can effectively avoid the risks of hypercalcemia and metal accumulation. Authoritative medical guidelines recommend sevelamer carbonate as a first-line treatment for hyperphosphatemia.
Among countries participating in the Dialysis Outcomes and Practice Patterns Study (DOPPS), China has the highest proportion of patients with uncontrolled serum phosphorus levels (27%), which is significantly higher than that in other countries (7%–10%). The use of phosphate binders, particularly non-calcium-based phosphate binders, is lower than in other countries, indicating substantial room for improvement in the future.
According to hospital sales data from Yaozhi.com, the market for hyperphosphatemia treatments exceeded RMB 1.5 billion in 2022, with sevelamer carbonate accounting for nearly 50% of the market share. Hospital sales of sevelamer carbonate reached RMB 708 million in 2022 and are projected to surpass RMB 800 million in 2023. The product is primarily distributed by three companies: Sanofi (Genzyme), Nanjing Hengsheng, and Shandong Xinhua. Currently, sevelamer carbonate tablets are the only dosage form available in clinical practice. According to data from the National Medical Products Administration (NMPA), a total of six domestic generic versions of sevelamer carbonate tablets had been approved by the end of 2023, indicating increasingly fierce future market competition.
Sevelamer for Dry Suspension is already marketed in the United States and Europe, with extensive clinical application, but it has not yet been imported into China. Anprime Biopharma filed its new drug application under Category 3.3 and, after more than 400 days, has obtained approval from the National Medical Products Administration (NMPA), becoming the first company to launch sevelamer for dry suspension in China. The market introduction of this product will provide better treatment options for a large number of patients with hyperphosphatemia.
Sevelamer carbonate tablets must be swallowed whole, which poses challenges for adult or pediatric patients with dysphagia. The DOPPS study has shown that difficulty in swallowing pills is a significant factor affecting treatment adherence in some patients with hyperphosphatemia. The dry suspension formulation effectively addresses the issue of swallowing whole tablets; when mixed with water, it facilitates administration for all patient populations, thereby improving medication adherence.
This collaboration between Zhiyun Health and Hangzhou Anprime Biopharma Co.,Ltd will create mutually beneficial synergies, enhance the accessibility of high-quality medications, and benefit a broader population of patients with chronic kidney disease. The scalability of Zhiyun Health’s SaaS network and its appeal to premium pharmaceutical manufacturers have once again been validated, which will further accelerate the company’s commercialization process.