Announcement • Jul 10
Mabwell (Shanghai) Bioscience Co., Ltd. Receives Approval for Clinical Trial Application for 9Mw5211 Injection
Mabwell (Shanghai) Bioscience Co., Ltd. has received the Approval Notice for Clinical Trials of Drugs from the National Medical Products Administration (NMPA), pursuant to which the clinical trial application for 9MW5211 injection for the treatment of Type 1 diabetes mellitus (T1DM) has been approved. Previously, its clinical trial application for indication of inflammatory bowel disease (IBD) has been approved by the NMPA and cleared by FDA respectively, and its clinical trial application for indication of multiple sclerosis (MS) has been approved by the NMPA. The Company is also actively advancing clinical trial applications for multiple other indications, and clinical trial applications for some of those indications have been accepted for review by the NMPA. Drug Name: 9MW5211 Injection. Application Matter: Registration clinical trial of domestically-produced drugs. Applicant: Mabwell (Shanghai) Bioscience Co., Ltd. Clinical Trial Approval Notice No.: 2026LP02009. Approval Conclusion: In accordance with the Drug Administration Law of the People’s Republic of China and relevant provisions, upon review, the clinical trial application for 9MW5211 Injection accepted on April 27, 2026 complies with the applicable requirements for drug registration, and approval is granted to conduct clinical trials of the product for the indication of T1DM. 9MW5211 is a highly specific, depleting and innovative antibody independently developed by the Company, designed to precisely intervene in the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases. The abnormal activation and tissue infiltration of immune cells act as the core driving factors in the occurrence and development of various autoimmune diseases. The target molecule of 9MW5211 is specifically expressed on the surface of pathogenic immune cells and serves as a vital biological marker of their abnormal activation. By selectively recognizing and depleting this population of pathogenic cells, 9MW5211 can effectively block the immune cascade, thereby delaying disease progression and ameliorating clinical symptoms. Through multiple rounds of molecular engineering optimization, 9MW5211 has demonstrated excellent target selectivity. While achieving efficient blockade, it significantly mitigates the risk of non-specific binding, ensuring deep depletion of pathogenic cells highly expressing the target protein. Such a unique mechanism of action is expected to not only bring deeper disease remission but also potentially support an extended dosing interval, thereby enhancing patient compliance and quality of life. Preclinical study results have demonstrated that 9MW5211 exhibits significant therapeutic potential in various mouse models of autoimmune diseases, suggesting its future clinical application may cover multiple major indications. As of the date of disclosure of this announcement, the clinical trial application for 9MW5211 for indications of T1DM, MS and IBD has been cleared by the NMPA, and the clinical trial application for indication of IBD has been cleared by FDA. The Company is also actively advancing clinical trial applications for multiple other indications, and clinical trial applications for some of those indications have been accepted for review by the NMPA. Concurrently, safety evaluations conducted in cynomolgus monkey models have shown a favourable safety profile. As the first clinical-stage drug candidate globally targeting this molecule, 9MW5211 holds the potential to usher in a new chapter in precision therapy for autoimmune diseases. T1DM is a chronic autoimmune disorder primarily characterized by the body’s immune system mistakenly attacking and destroying insulin-producing beta cells in the pancreas. This results in absolute insulin deficiency and subsequent persistent elevation of blood glucose levels. At present, insulin replacement therapy remains the cornerstone of the treatment landscape for T1DM, yet its therapeutic goals and implementation approaches have undergone marked evolution. Conventional T1DM treatment primarily centers on hyperglycaemia control; by contrast, the prevailing treatment trend places greater emphasis on achieving individualized glycaemic control approximating physiological levels while avoiding hypoglycaemia and diabetic ketoacidosis (DKA). Additional objectives include improving patients’ quality of life, mitigating the risk of chronic complications and extending healthy life expectancy. For patients with T1DM, especially newly diagnosed individuals, the Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition) highlights the importance of preserving residual beta-cell function, reducing the incidence of T1DM-related complications, and lowering disability and mortality rates. According to the 2025 IDF Diabetes Atlas released by the International Diabetes Federation (IDF), there are 9,150,000 patients with T1DM worldwide. Of these patients, 1,810,000 are children and adolescents under 20 years of age, accounting for 19.8%, 6,280,000 are aged between 20 and 59 years, representing 68.6%, and 1,060,000 are aged 60 years or above, making up 11.8%. In China, the prevalence of T1DM stands at 599,000 patients, including 117,000 children and adolescents under 20 years old. MS is a chronic autoimmune disease characterized by inflammatory damage to the protective myelin sheaths surrounding the nerves of the brain and spinal cord. The number of MS patients globally increased from 2,800,000 cases in 2020 to 3,000,000 cases in 2024, and is projected to reach approximately 3,500,000 cases by 2035. In China, the number of MS patients increased from 32,800 cases in 2020 to 33,900 cases in 2024, and is expected to reach 35,500 cases by 2035. IBD is a chronic, relapsing, immune-mediated disorder of the gastrointestinal tract, which primarily includes ulcerative colitis and Crohn’s disease.
