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news.China’s National Medical Products Administration (NMPA) has granted approval to the new drug application (NDA) of Shanghai Fosun Pharmaceutical Industrial Development’s phosphate absorption inhibitor, Tenapanor Hydrochloride tablets, intended for controlling levels of serum phosphorus in dialysis patients with chronic kidney disease (CKD).
The tablets are indicated for individuals who have either insufficient response or cannot tolerate phosphorus binders. Credit: danilo.alvesd on Unsplash.
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Carrying the Chinese trade name of Wan Ti Le, the tablets are indicated for individuals who have either insufficient response or cannot tolerate phosphorus binders.
They are claimed to be the first to gain approval in the country, paving the way for multi-mechanism synergistic phosphate control while providing hope for individuals with hyperphosphatemia on haemodialysis in the country.
Fosun Pharma Global R&D Center CEO and executive president Xingli Wang said: “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.
“Fosun Pharma is committed to addressing unmet clinical needs by focusing on innovative research and development (R&D) in core therapeutic areas such as oncology, immunology, and chronic diseases.”
Licenced by Fosun Pharma Industrial from Ardelyx, the tablets are the oral inhibitor of the intestinal sodium/hydrogen exchanger 3 (NHE3).
Tenapanor gained approval from the US Food and Drug Administration (FDA) in October 2023 for decreasing serum phosphorus in CKD adults on dialysis especially as an add-on treatment in those who have insufficient response or cannot tolerate any phosphorus binder doses.
It gained approval in Hong Kong Special Administrative Region (SAR) as well as in the US for treating irritable bowel syndrome with constipation.
With NHE3 inhibition, Tenapanor claims to “tighten” intercellular junctions, minimising the paracellular pathway permeability to phosphate, the main route for the absorption of intestinal phosphate.
This function reduces the absorption of phosphate, leading to a decreased serum phosphorus level.
