Today (June 4th), the official website of the National Medical Products Administration (NMPA) shows that Otsuka Pharmaceutical's sipelimab injection (Izaike) has been officially approved for marketing, with the indication being adult patients with primary immunoglobulin A nephropathy (IgAN). This is the first monoclonal antibody targeting the proliferation-inducing ligand (APRIL) to be approved in China and the world.

IgA nephropathy is the most common primary glomerular disease worldwide and one of the leading causes of chronic kidney disease and end-stage renal disease (ESKD) in China. It commonly affects people aged 20-40, and some patients may progress to end-stage renal disease several years after diagnosis, highlighting the urgent need for innovative therapies to slow the deterioration of kidney function.

Sipelimab was acquired by Otsuka Pharmaceutical in 2018 through its acquisition of Vistara for $430 million. Its mechanism of action targets the core aspects of the pathogenesis of IgA nephropathy.

In the pathological model of IgA nephropathy, APRIL , as a key cytokine of the tumor necrosis factor (TNF) family, drives kidney damage by promoting the production of pathogenic galactose-deficient IgA1 (Gd-IgA1) antibodies and the formation of immune complexes.

Sbelimab selectively binds to and inhibits APRIL activity, reducing Gd-IgA1 levels at the source and decreasing the deposition of immune complexes in the kidneys, thereby achieving etiological treatment.

The drug's approval was based on solid global clinical data. The Phase III VISIONARY study enrolled 510 patients. Interim analysis showed that, in addition to optimized supportive care, after 9 months of treatment with sbelimumab (400 mg, subcutaneous injection once a month), patients in the 24-hour urine protein/creatinine ratio (uPCR-24h) decreased by 50.2% from baseline , and by an additional 51.2% compared to the placebo group , a statistically significant difference (P<0.0001).

In terms of safety, the incidence of treatment-induced adverse events (TEAEs) in the sbelimab group was 76.3%, the incidence of serious adverse events was only 3.9%, no deaths were reported, and the overall tolerability was good .

Previously, sipelimab received accelerated approval from the U.S. FDA on November 26, 2025, for the treatment of adult patients with primary IgA nephropathy at risk of disease progression to reduce proteinuria. This drug thus became the world's first approved APRIL-targeted therapy.

In the domestic market, several innovative drugs have been introduced to treat IgA nephropathy . In November 2023, budesonide enteric-coated capsules (Nexokang) received conditional approval from the NMPA, becoming the world's first causal treatment for IgA nephropathy. In August and September 2025, Novartis's Iptacopan and Atrasentan were approved in China.

The availability of sbelimumab further enriches the options for targeted therapy, and its once-monthly dosing frequency significantly improves patient compliance and convenience.
In conclusion , with the approval of svelimumab, the treatment of IgA nephropathy has officially entered the APRIL targeted era. Whether svelimumab can gain a first-mover advantage in the increasingly competitive IgA nephropathy market remains to be seen.

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