Fosun Pharma Received NMPA Approval for Wan Ti Le (Tenapanor Hydrochloride Tablets)

Bringing New Hope to Chinese Dialysis Patients with Hyperphosphatemia

SHANGHAI, Feb. 26, 2025 /PRNewswire/ -- Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma Industrial"), has received approval from the National Medical Products Administration ("NMPA") for the New Drug Application ("NDA") for Tenapanor Hydrochloride Tablets (Chinese trade name: Wan Ti Le, the "New Drug"), an innovative phosphate absorption inhibitor with a novel mechanism, with the indication being for the control of serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or are intolerant to phosphorus binders.

As the world's first and currently only approved phosphate absorption inhibitor, Tenapanor Hydrochloride Tablets has been officially approved in China, ushering in a new era of multi-mechanism synergistic phosphate control and offering new hope for patients with hyperphosphatemia on hemodialysis in China.

"The approval of tenapanor for the treatment of adult dialysis patients with chronic kidney disease in China market brings new hope for dialysis patients with hyperphosphatemia in China," said Xingli Wang, Executive President, CEO of Global R&D Center of Fosun Pharma, "Fosun Pharma is committed to addressing unmet clinical needs by focusing on innovative R&D in core therapeutic areas such as oncology, immunology, and chronic diseases. We look forward to our continued collaboration with Ardelyx as we advance the development and commercialization of more innovative therapies, bringing greater benefits to patients.

"The approval of tenapanor for hyperphosphatemia in China marks another important milestone in Ardelyx's commitment to bringing our novel therapies to patients with unmet medical needs globally," said Mike Raab, president and chief executive officer of Ardelyx. "I thank our partners at Fosun Pharma for their continued efforts to support this approval. Fosun Pharma is a leading healthcare company in China with a strong focus and track record of successfully marketing cardiorenal medicines in China and shares our commitment to improving the lives of patients. We look forward to further collaboration as Fosun Pharma brings this treatment to patients."

Tenapanor Hydrochloride Tablets is a First-in-class oral intestinal sodium/hydrogen exchanger 3 (NHE3) inhibitor licensed by Fosun Pharma Industrial from Ardelyx, Inc. In October 2023, Tenapanor was approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. Tenapanor is also approved for the treatment of Irritable Bowel syndrome with Constipation in the U.S. and Hong Kong SAR.

For many years, the rate of achieving target serum phosphate levels in hemodialysis patients in China has been lower than the international standards^[1]. Despite existing pharmacotherapy, a significant proportion of patients fail to meet the target phosphate levels. Data indicate that by the end of 2023, there were more than one million patients on maintenance hemodialysis in China, with an annual growth rate of approximately 10%. Among these patients, 76% have hyperphosphatemia, and the rate of achieving target phosphate levels is only 39%^[2] (according to China's hemodialysis quality control standards: serum phosphate 1.13–1.78 mmol/L). If the target range for serum phosphate is set at 0.87–1.45 mmol/L, as stipulated by the Chinese guidelines for the diagnosis and treatment of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD), the achievement rate decreases to 26.7%^[3]. Given the current situation where the blood phosphorus levels of dialysis patients are poorly controlled, the National Health Commission of China listed "improving phosphate control rates in hemodialysis patients" as a key quality control improvement target for 2024.

Tenapanor is a local inhibitor that targets the NA(+)/H(+) exchanger-3 (NHE3), a reverse transporter expressed on the apical surface of the epithelium in the small intestine and colon. By inhibiting NHE3, the drug tightens intercellular junctions, thereby reducing the permeability of the paracellular pathway to phosphate, which is the primary route for intestinal phosphate absorption. This action leads to a decrease in phosphate absorption and, consequently, a reduction in serum phosphorus levels^[4].

Owing to its novel mechanism of action, tenapanor can be used in combination with phosphate binders to further significantly reduce serum phosphate levels and improve the rate of achieving target levels. In a randomized, double-blind, placebo-controlled study^[5], 164 hemodialysis patients with hyperphosphatemia were enrolled. After 8 weeks of treatment with tenapanor in combination with phosphate binders, serum phosphate levels decreased by an additional 0.57 mmol/L compared to phosphate binders alone. In another multicenter, randomized, open-label study^[6], 303 hemodialysis patients who were not achieving target phosphate levels with phosphate binders were switched to a tenapanor-based regimen (tenapanor 30 mg BID, with phosphate binders added or adjusted if necessary). After 10 weeks of treatment, the rate of achieving target phosphate levels increased by 34.4% to 38.2%.

A tenapanor can lower levels of parathyroid hormone (PTH)^[7] and fibroblast growth factor 23 (FGF23)^[8], thereby aiding in the comprehensive achievement of key therapeutic targets in the management of chronic kidney disease–mineral and bone disorder (CKD-MBD).

SOURCE Fosun Pharma