Lupus nephritis is one of the most common and serious complications of systemic lupus erythematosus (SLE). Approximately 40%-60% of SLE patients will experience kidney involvement. If poorly controlled, about 20% of patients will progress to end-stage renal disease within 10 years, requiring dialysis or kidney transplantation, which seriously affects the patient's quality of life and survival.
On April 10, 2026, according to the latest information on the website of the Center for Drug Evaluation (CDE) of China , Roche Pharma 's application for a new indication for its oxotuzumab injection, submitted under category 3.1 of therapeutic biological products, has been accepted. Based on publicly available information and clinical trial progress, it is speculated that the new indication applied for is active lupus nephritis (LN) . This means that this anti-CD20 monoclonal antibody, the world's first to be approved for this indication, has officially begun the approval process for marketing in China.
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According to publicly available information , oxotuzumab is a second-generation glycosylated type II anti-CD20 monoclonal antibody developed by Roche, and it is also the world's first glycosylated type II anti-CD20 monoclonal antibody. Compared with the first-generation CD20 monoclonal antibody, it significantly enhances antibody-dependent cell-mediated cytotoxicity (ADCC) through glycosylation of the Fc fragment, enabling more efficient and thorough elimination of B cells, while retaining the ability to directly induce B cell apoptosis, achieving dual optimization in efficacy and safety.
The results of the pivotal Phase III REGENCY study (NCT04221477) of oxotuzumab in the field of lupus nephritis were published in the New England Journal of Medicine, providing solid clinical evidence for this marketing application.
The study included 271 patients worldwide with active type III or IV lupus nephritis. In addition to standard treatment (MMF + glucocorticoids), patients received either oxutuzumab or placebo. At week 76, 46.4% of patients in the oxutuzumab group achieved complete renal remission, significantly higher than the 33.1% in the placebo group, representing a 40% relative risk increase . Simultaneously, patients in the oxutuzumab group showed a significant reduction in corticosteroid dosage, and significant improvements in inflammatory markers such as proteinuria and anti-dsDNA antibody titers. The safety profile was consistent with previous studies, with no new safety signals observed, and the incidence of serious infections was comparable to that in the placebo group.
Based on the results of this study, oxetuzumab was approved by the US FDA in 2025 for the treatment of adult patients with active lupus nephritis, becoming the world's first anti-CD20 monoclonal antibody approved for this indication. This application for marketing approval in China is a localization effort following its global approval.
In 2013, oxutuzumab injection was first approved by the US FDA for the treatment of chronic lymphocytic leukemia/ small lymphocytic lymphoma as a first-line therapy. Currently, the drug is approved for indications overseas including chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, and lupus nephritis.
In June 2021, oxetuzumab was first approved for marketing in China, for use in combination with chemotherapy for adult patients with follicular lymphoma. In addition to the approved indications and the one submitted for approval this time, on April 2, 2026, Roche submitted its first non-oncology indication marketing application in China for the treatment of patients aged 2 years and older with primary nephrotic syndrome.
Currently, the standard treatment for lupus nephritis in China mainly involves glucocorticoids combined with immunosuppressants such as mycophenolate mofetil (MMF). However, more than 50% of patients still cannot achieve complete renal remission, and long-term use of high-dose hormones can lead to serious side effects such as infection, osteoporosis, and metabolic disorders. There is a huge unmet clinical need.
The approval of this new indication for oxutuzumab in China will provide a novel targeted therapy option for the treatment of lupus nephritis, potentially breaking through the limitations of existing treatments, helping more patients achieve renal remission, reducing hormone dependence, and slowing disease progression. It also brings new hope to lupus nephritis patients in China.
Interpretation of Class 3.1 Registration Classification for Therapeutic Biological Products :
The registration classification for oxotuzumab is 3.1, corresponding to the category of "biological products already marketed overseas applying for importation " in the "Classification and Application Requirements for Biological Products Registration ," i.e., biological products manufactured overseas that are already marketed overseas but not in China applying for marketing approval. This classification means that oxotuzumab's indication for lupus nephritis has already been approved for marketing overseas. This application is based on overseas clinical data, combined with bridging study data from domestic patients, and is seeking marketing approval in China. The approval process will follow the relevant requirements for imported drug registration, which is expected to accelerate the product's approval process in China.

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