Mabwell-B(02493.HK): IND Application of 9MW5211 Injection for Type 1 Diabetes Mellitus Accepted by NMPA
NewTimeSpace News: Mabwell (Shanghai) Bioscience Co., Ltd. (02493.HK) announced that the clinical trial application for 9MW5211 Injection indicated for Type 1 Diabetes Mellitus (T1DM) has been approved by the National Medical Products Administration (NMPA). Previously, its clinical trial application for Inflammatory Bowel Disease (IBD) was granted approval by both NMPA and the U.S. Food and Drug Administration (FDA), while the application for Multiple Sclerosis (MS) also obtained NMPA clearance.
NewTimeSpace News: Mabwell (Shanghai) Bioscience Co., Ltd. issued a voluntary announcement dated 7 July 2026, disclosing that the clinical trial application of 9MW5211 Injection for the indication of Type 1 Diabetes Mellitus (T1DM) has been approved by NMPA.
9MW5211 is a novel highly specific sweeping antibody independently developed by the Company, which precisely intervenes the core pathological mechanism mediated by aberrant immune cells in autoimmune diseases. It selectively recognises and eliminates pathogenic cells to effectively block immune cascade reactions and slow disease progression. Optimised via multiple rounds of molecular engineering, 9MW5211 delivers superior target selectivity, enabling potent target inhibition while markedly lowering the risk of non-specific binding.
As the world’s first clinical-stage candidate drug targeting this molecule, 9MW5211 is rapidly expanding its indication portfolio: applications for T1DM, MS and IBD have all secured NMPA approvals, with IBD additionally cleared by the FDA. The Company is actively advancing clinical trial filings for numerous other indications.
According to the 2025 IDF Diabetes Atlas, there are 9.15 million patients living with Type 1 diabetes worldwide, including 599,000 cases in China. The global patient pool of Multiple Sclerosis reached 3 million in 2024, while 7 million new cases of Inflammatory Bowel Disease were recorded globally in 2023.
NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.
Tags：
- Mabwell-B (02493.HK)： 6MW5311 Clinical Trial Application Approved by NMPA
- Mabwell-B (02493.HK): 6MW5311 Injection Receives FDA Clinical Trial Approval as World’s First LILRB4/CD3-Targeted TCE Innovative Drug
- Mabwell(02493.HK): Injection 9MW5211 Approved by NMPA for Clinical Trials in Multiple Sclerosis
- Mabwell(02493.HK) Elects Dr. Gui Xun as Employee Representative Director
