On October 15, Rongchang Biopharma announced that its independently developed, first-in-class BLyS/APRIL dual-target fusion protein drug, Tetasip, for the treatment of primary immunoglobulin A (IgA) nephropathy has been accepted for marketing approval by the China Drug Administration (CDE) and has been placed under priority review. This marks Tetasip as the first domestically developed, research-driven new drug to be approved for marketing in the field of IgA nephropathy, bringing new hope to patients.

Tetasip is the world's first innovative dual-target fusion protein drug that simultaneously targets B-cell activating factor (BLyS) and proliferation-inducing ligand (APRIL). These two cytokines are significantly elevated in patients with IgA nephropathy, driving abnormal B cell activation, antibody class switching, and the production of pathogenic IgA. Ultimately, this leads to the deposition of immune complexes in the glomeruli, triggering inflammation and tissue damage. By simultaneously inhibiting BLyS and APRIL, Tetasip is able to reduce the number of mature B cells and plasma cells, inhibiting the production of abnormal immunoglobulins at the source and halting the progression of kidney damage.

In a Phase III clinical study, Tetasip demonstrated significant efficacy. Compared to the placebo group, the 24-hour urine protein-to-creatinine ratio (UPCR) in the Tetasip group was reduced by 55% at 39 weeks (P<0.0001), with good tolerability and safety. This result demonstrates Tetasip's superior clinical efficacy in reducing proteinuria and provides scientific support for further protection of renal function.

IgA nephropathy is one of the most common primary glomerular diseases worldwide, manifesting as hematuria, proteinuria, and progressive renal failure. According to Frost & Sullivan, the global number of IgA nephropathy patients is expected to reach 10.16 million by 2030, with approximately 2.37 million in China. IgA nephropathy patients in China account for approximately 54.3% of all renal biopsy cases, of which 30%-40% will progress to end-stage renal disease (ESRD). Existing therapies, such as hormones and traditional immunosuppressants, have limited efficacy, and new drugs are urgently needed to treat IgA nephropathy.

The CDE's acceptance of the NDA for Tetasipip and its inclusion in the Priority Review designation not only demonstrates national recognition of its clinical value but also demonstrates Rongchang Biopharma's strength in innovative drug research and development. As a world-first, dual-target innovative drug, Tetasipip has the potential to provide a more effective treatment option for patients with IgA nephropathy, significantly improving their prognosis and quality of life.

Furthermore, the launch of Tetasip will further solidify Rongchang Biopharma's leading position in the autoimmune disease field. Previously, the drug has been approved for three indications in China (see the figure below for details). The advancement of Tetasip for the IgA nephropathy indication marks another advancement in Tetasip's indication portfolio in the autoimmune disease field.

Conclusion: The CDE's acceptance of the NDA for Tetasip and its inclusion in the Priority Review designation marks a significant milestone for Rongchang Biopharma in innovative drug development. Its unique dual-target mechanism and remarkable clinical efficacy provide a new treatment option for patients with IgA nephropathy and inject new vitality into the global field of autoimmune disease treatment.

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