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 China’s National Medical Products Administration (NMPA) for the New Drug Application (NDA) of Tenapanor Hydrochloride Tablets (Chinese trade name: Wan Ti Le). This first-in-class phosphate absorption inhibitor is indicated for the control of serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or intolerance to conventional phosphorus binders.

A Breakthrough in Hyperphosphatemia Management

As the world’s first and only approved phosphate absorption inhibitor, Tenapanor represents a new era of multi-mechanism phosphate control, addressing a significant unmet need for dialysis patients in China.

"The approval of Tenapanor in China marks a major advancement in the treatment of hyperphosphatemia for dialysis patients," said Xingli Wang, Executive President and CEO of Global R&D Center, Fosun Pharma. "At Fosun Pharma, we remain committed to developing and commercializing innovative therapies to improve patient outcomes in key therapeutic areas, including chronic kidney disease. Our continued collaboration with Ardelyx reflects this commitment."

Mike Raab, President and CEO of Ardelyx, Inc., added: "We are excited to see Tenapanor reach more patients in China through our partnership with Fosun Pharma, a leader in the country’s healthcare sector. This approval underscores our shared mission to address critical gaps in care for patients worldwide."

Addressing a Growing Unmet Need in China

Despite advancements in CKD treatment, phosphorus control remains a major challenge in China. According to national data:

• Over 1 million patients in China are on maintenance hemodialysis, with an annual growth rate of approximately 10%.
• 76% of these patients suffer from hyperphosphatemia, yet only 39% achieve target serum phosphate levels under current treatment standards.
• Stricter clinical guidelines recommend even lower phosphate levels, but only 26.7% of patients meet these targets.

Recognizing this urgent need, China’s National Health Commission has prioritized "improving phosphate control rates in hemodialysis patients" as a key quality improvement goal for 2024.

How Tenapanor Works: A Novel Mechanism for Phosphate Control

Tenapanor is an oral sodium/hydrogen exchanger 3 (NHE3) inhibitor that works differently from traditional phosphate binders. Instead of binding phosphorus in the digestive tract, it reduces phosphate absorption at the source by tightening intercellular junctions in the intestinal lining. This unique mechanism leads to a significant reduction in serum phosphorus levels.

Clinical Evidence and Potential Impact

Tenapanor has demonstrated strong efficacy in clinical trials, both as a monotherapy and in combination with phosphate binders:

• Combination Therapy: In an 8-week randomized controlled study, patients taking Tenapanor alongside phosphate binders saw an additional 0.57 mmol/L reduction in serum phosphate levels compared to binders alone.
• Binder-Free Approach: In a separate study, patients who switched from binders to a Tenapanor-based regimen experienced a 34.4% to 38.2% increase in target phosphate level achievement after 10 weeks.
• Comprehensive Benefits: Tenapanor has also been shown to reduce parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23), key markers in managing CKD-MBD (Chronic Kidney Disease – Mineral and Bone Disorder).

A Global Therapy with Expanding Reach

Tenapanor was first approved by the U.S. FDA in October 2023 for adults with CKD on dialysis who do not respond adequately to phosphate binders. It is also approved for irritable bowel syndrome with constipation (IBS-C) in the U.S. and Hong Kong SAR. With China’s NMPA approval, Tenapanor now expands its global footprint, reinforcing its potential as a game-changing treatment for hyperphosphatemia.

Looking Ahead

The approval of Tenapanor in China reflects Fosun Pharma’s leadership in advancing innovative therapies for cardiorenal diseases. As Fosun Pharma and Ardelyx continue their collaboration, millions of dialysis patients in China stand to benefit from a new, more effective approach to phosphate control.