China-based Everest Medicines has recently launched Nefecon (budesonide DR) to treat primary immunoglobulin A nephropathy (IgAN) in China. It is the first approved medicine for IgAN by China’s National Medical Products Administration (NMPA). It represents an innovative treatment option for IgAN patients with more rapid disease progression compared to the American and European populations, says GlobalData, a leading data and analytics company.

Nefecon is a glucocorticoid that acts as an anti-inflammatory agent. It is formulated as delayed-release capsule that is enteric-coated to remain intact until it releases budesonide to the distal ileum. In the global Phase III NefIgArd clinical trial, Nefecon can delay the deterioration of kidney function by 66%, delay progression to end-stage renal disease (ESRD) by 12.8 years, decrease proteinuria, and reduce deterioration of EGFR. It is also safe and well-tolerated.

According to GlobalData’s Pharma Intelligence Center, the number of incident cases of IgAN in China is expected to increase at an annual growth rate (AGR) of 0.08% from 51,816 in 2023 to 52,153 in 2032.

Nadim Anwer, Pharma Analyst at GlobalData, comments: “The currently available treatments such as angiotensin-converting enzyme (ACE) inhibitors and renin-angiotensin system (RAS) inhibitors can only alleviate the symptoms associated with IgAN and do not change disease progression. As a result, patients are at risk of developing ESRD, which may later require dialysis or kidney transplant. Nefecon, the Chinese-first approved treatment for IgAN, is said to reduce kidney function loss and delay disease progression.”

IgAN is the most common primary glomerular disease and is highly prevalent in China and Asia. The lack of targeted treatment highlights a significant unmet need for IgAN patients in China and other Asian countries.

Nefecon is the first non-oncology treatment to receive Breakthrough Therapy Designation in China by the NMPA, and the first-ever treatment for IgAN to receive full approval from the US Food and Drug Administration (FDA) in December 2023. The drug demonstrates its ability to preserve kidney function and significantly delay disease progression. Additionally, it is approved in multiple countries and territories across Europe and Asia.

As per GlobalData’s Pharma Intelligence Center, Nefecon is expected to generate sales of $395 million by 2030 in Mainland China, Hong Kong, Macau, Taiwan, Singapore, and South Korea.

Anwer concludes: “Nefecon represents a paradigm shift in the treatment of patients with IgAN, who have a risk of developing kidney failure. Nefecon brings new hope to IgAN patients in China and other Asia countries and provide physicians with a better option to treat the disease from its origin. Moreover, with a large IgAN patient pool and Everest’s strong presence in the Chinese market, Nefecon could generate significant revenues.”