ShanghaiJune 8, 2026 /PRNewswire/ — On June 4, Otsuka Pharmaceutical announced that Sibeprenlimab Injection (brand name: Yizaike®, English brand name: Voyxact®), the world’s first biologic approved for the treatment of Immunoglobulin A (IgA) nephropathy, has been officially approved by China’s National Medical Products Administration (NMPA). It is indicated for reducing proteinuria in adult patients with primary IgA nephropathy (hereinafter referred to as “IgA nephropathy”) at risk of disease progression. This approval marks a new era for IgA nephropathy treatment in China, entering a phase of precision targeting and upstream blockade, offering a milestone new treatment option for millions of Chinese patients who have long faced the risk of progression to renal failure and lacked specific, etiology-based therapies.
The approval of Sibeprenlimab in China is based on the positive results of the Phase 3 VISIONARY study. The VISIONARY study is one of the largest global Phase 3, double-blind, placebo-controlled studies in the field of IgA nephropathy to date[1], enrolling 510 patients (including 102 patients from mainland China) from 31 countries across 5 continents. The VISIONARY study showed that treatment with Sibeprenlimab for 9 months resulted in a 51.2% reduction in 24-hour urine protein-to-creatinine ratio (UPCR-24h) compared to the placebo group, with a 54.3% reduction at 12 months. In the Chinese subgroup, treatment with Sibeprenlimab for 9 months led to a 61.9% reduction in UPCR-24h compared to placebo, demonstrating excellent therapeutic efficacy[2]. Additionally, exploratory endpoints of this study also indicated a positive effect of Sibeprenlimab in slowing the decline of estimated glomerular filtration rate (eGFR). Global cohort results showed that the change in eGFR from baseline at 12 months was +0.7 mL/min/1.73 m² in the Sibeprenlimab group, while the placebo group experienced a decline of 4.8 units, resulting in a treatment difference of 5.5 mL/min/1.73 m2[3]. Sibeprenlimab has a favorable overall safety and tolerability profile and is convenient to use, administered as a subcutaneous injection once every four weeks, with a dosing frequency significantly lower than other similar IgA nephropathy treatments, offering patients a convenient option.
IgA nephropathy is a glomerulonephritis characterized by the deposition of IgA or predominantly IgA immunoglobulins in the glomerular mesangium, and is the most common primary glomerular disease worldwide[4]. The clinical manifestations of the disease are diverse, including episodic gross hematuria, asymptomatic microscopic hematuria with or without proteinuria, hypertension, acute kidney injury, and even chronic renal failure. IgA nephropathy has the highest incidence in Asia, accounting for up to 54.3% of renal biopsy cases in China[5], and is one of the leading causes of chronic kidney disease and end-stage renal disease in the country[6].
Patients with IgA nephropathy in China tend to have more severe pathological changes and faster disease progression. Data shows that nearly 80% of IgA nephropathy patients progress to end-stage disease within 20 years of diagnosis, requiring dialysis or kidney transplantation to sustain life[4]. For a long time, there has been a lack of precise, etiology-based therapeutic drugs that can directly target the core pathogenesis of IgA nephropathy, stably block disease progression, and offer superior safety. Traditional treatments primarily rely on renin-angiotensin system (RAS) inhibitors, corticosteroids, and immunosuppressants, which cannot block the pathogenic pathway at its source. Consequently, a large number of patients continue to experience persistent proteinuria and progressive decline in renal function, leading to poor outcomes[7].
Sibeprenlimab is the world’s first biologic approved for the treatment of IgA nephropathy. It targets and inhibits A Proliferation-Inducing Ligand (APRIL), thereby blocking the core pathogenesis of IgA nephropathy at an upstream level. APRIL plays a central driving role in the “four-hit” pathogenic pathway of IgA nephropathy[8]. By precisely blocking APRIL, Sibeprenlimab interrupts the first and second “hits” of the pathogenic cascade[8]; significantly reduces proteinuria and hematuria, stabilizes renal function; slows the decline in eGFR, delays the need for dialysis or kidney transplantation, and improves patients’ long-term prognosis[9]. This mechanism of action of Sibeprenlimab complements traditional supportive care, together building a precise, etiology-based modern treatment system for IgA nephropathy.
Professor Zhang Hong, a member of the VISIONARY study Global Steering Committee, Chair of the Scientific Committee of the Chinese IgA Nephropathy Collaborative Group, and from the Department of Nephrology at Peking University First Hospital, stated: “For a long time, clinical management of IgA nephropathy has largely involved intervention after the onset of consequences such as proteinuria, inflammation, and declining renal function. By targeting and inhibiting APRIL, Sibeprenlimab reduces the production of pathogenic IgA and related autoantibodies from upstream, cutting off the key initiating steps in the ‘four-hit’ cascade of IgA nephropathy. This advances treatment from traditional symptomatic supportive care to a new phase of mechanism-targeted, precise, etiology-based therapy. The VISIONARY study is the largest completed global Phase 3 study for IgA nephropathy to date. Numerous Chinese clinical institutions and researchers actively participated in this global study, contributing clinical evidence representing China and enhancing the global trial’s representativeness and regional diversity. Thanks to this, China became the second country, after the United States, to approve this drug. The study shows that Sibeprenlimab can significantly reduce proteinuria and demonstrates positive potential in stabilizing renal function. For IgA nephropathy patients at risk of disease progression, reductions in proteinuria and protection of renal function not only signify better control of current disease activity but also predict improved long-term renal outcomes. This approval marks an important upgrade in the management philosophy of IgA nephropathy, providing Chinese patients with an innovative treatment option that offers both clear efficacy and potential for long-term benefit.”
About Sibeprenlimab[10]
Sibeprenlimab is a monoclonal antibody that, by binding to and neutralizing APRIL, helps reduce levels of Immunoglobulin A (IgA) and Gd-IgA1. A decrease in Gd-IgA1 levels can further reduce the production of autoantibodies, thereby decreasing the formation of immune complexes, reducing their deposition in the kidneys, and alleviating proteinuria and renal inflammation. By reducing the production of Gd-IgA1, Sibeprenlimab is expected to slow the progression of kidney damage and the onset of end-stage renal disease (ESRD). By blocking APRIL, Sibeprenlimab is expected to intervene in one of the specific driving mechanisms leading to nephron loss in IgA nephropathy.
About Otsuka Pharmaceutical[11]
In 1981, Otsuka Pharmaceutical Co., Ltd. established a joint venture, China Otsuka Pharmaceutical Co., Ltd., in Tianjin, dedicated to leveraging Japan’s advanced technology and management expertise, and assuming the functions of a regional headquarters in China.
Otsuka (China) Investment Co., Ltd. regards disease treatment as a long-term, comprehensive development endeavor, extending its therapeutic drug business in China to multiple fields. The company adheres to the Otsuka Group’s tradition of focusing on health as its core business, not only concerning itself with the rational and effective treatment of diseases but also with active disease prevention and daily health maintenance. Through its Nutraceuticals* business in China, it provides comprehensive support for the health and quality of life of the Chinese people.
*Nutraceuticals is a coined term: Nutrition + Pharmaceuticals
References:
[2] P230. Evaluating Sibeprenlimab in Patients With IgA Nephropathy: Results From an Interim Analysis of the China Cohort of the Phase 3 VISIONARY Trial. ISN World Congress of Nephrology 2026 (WCN’26); March 28-31, 2026; Yokohama, Japan.
[3] Perkovic V, et al. Presented at: ERA June 3-6, 2026; Glasgow, UK.
[5] Clinical Practice Guidelines Working Group of the Nephrology Dialysis Committee, China Non-Government Medical Institutions Association. 60 Clinical Questions on IgA Nephropathy Practice (2026 Edition)[J]. Chinese Journal of Nephrology, 2026, 42(01):60-76.
[6] Nephrology and Blood Purification Professional Committee, China Health Culture Association. Chinese Expert Consensus on the Management and Treatment of Primary IgA Nephropathy[J]. Electronic Journal of Chinese Nephrology Research, 2024, 13(01): 1-8.
[9] Mathur M, et al. New England Journal of Medicine, 2024, 390(1): 20-31.
[10] Otsuka Global Official Website. Otsuka Announces Positive Interim Results from the Phase 3 Trial of Sibeprenlimab for the Treatment of Immunoglobulin A Nephropathy in Adults｜October 22, 2024｜News Releases | Otsuka Pharmaceutical Co., Ltd. [Accessed: June 5, 2026]
[11] Otsuka China Official Website. Otsuka (China) Investment Co., Ltd. https://www.otsuka.com.cn/about-otsuka/index.html [Accessed: June 5, 2026]