Shanghai, China, January 7, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco," HKEX stock code: 01541.HK) announced that the Investigational New Drug (IND) application for its self-developed Amouravfop alfa (IMM0306) as a monotherapy for Primary Membranous Nephropathy (PMN) has been officially accepted by the National Medical Products Administration (NMPA). This marks another important milestone in IMM0306's pipeline expansion in autoimmune nephrology, signaling the innovative drug's progression into broader glomerular disease indications.

Significant Unmet Medical Needs in Primary Membranous Nephropathy Treatment

Primary Membranous Nephropathy is one of the most common pathological types of adult nephrotic syndrome, characterized by immune complex deposition beneath the glomerular basement membrane epithelial cells with diffuse basement membrane thickening. Approximately 30%-40% of patients progress to End-Stage Renal Disease (ESRD). Current treatment options (e.g., corticosteroids combined with immunosuppressants, anti-CD20 monoclonal antibodies) face challenges of low remission rates, high recurrence rates, and substantial infection risks, creating an urgent clinical demand for more targeted and safer therapeutic alternatives.

IMM0306's Phase Ib/II Clinical Data in Systemic Lupus Erythematosus (SLE) Attracted High Attention at ACR Annual Meeting

ImmuneOnco presented the latest results from the Phase Ib/II clinical study of IMM0306 (intravenous formulation) in Systemic Lupus Erythematosus (SLE) as a poster presentation at the American College of Rheumatology (ACR) Annual Meeting held in Chicago, USA, on October 28, 2025 (data cutoff: September 10, 2025). The study demonstrated significant efficacy and favorable safety profiles in patients with moderate-to-severe active SLE. At the 0.8 mg/kg and 1.2 mg/kg dose cohorts, the 24-week SRI-4 response rates reached 71.4% (5/7) and 80.0% (4/5), respectively, with complete resolution of clinical symptoms including arthritis and vasculitis, and significant improvements in key biomarkers such as anti-dsDNA antibodies and complement C3/C4. The drug exhibited good tolerability with no observed Cytokine Release Syndrome (CRS) or major infection events. Minor transient hematological toxicities occurring during dosing were projected to be driven by peak plasma concentration and were overall controllable. These data provide robust clinical evidence supporting IMM0306's application in autoimmune diseases.

Subcutaneous Formulation IMM0306S IND Application Simultaneously Accepted

Previously, the IND application for Amouravfop alfa subcutaneous formulation (IMM0306S) in Systemic Lupus Erythematosus (SLE) has been officially accepted by NMPA. Compared to intravenous administration, the subcutaneous formulation significantly enhances dosing convenience, improves patient treatment experience, and offers a superior option for long-term disease management. The development of IMM0306S will further enrich the company's product portfolio in autoimmune diseases.

IMM0306's Mechanism of Action Demonstrates Therapeutic Potential in Autoimmune Nephrology

Building upon validated efficacy in SLE and lupus nephritis, IMM0306 demonstrates unique therapeutic advantages through simultaneous targeting of CD47 and CD20 molecules:

Enhanced B-cell depletion: Clinically confirmed in SLE and lupus nephritis patients,

IMM0306 exhibits significantly superior depletion effects on CD19+ B cells compared to conventional anti-CD20 monoclonal antibody drugs

Blockade of "Don't Eat Me" signal: Blocking the CD47-SIRPα pathway enhances macrophage-mediated clearance of pathogenic B cells, theoretically reducing production of autoantibodies (e.g., anti-PLA2R antibodies) to intervene in PMN pathogenesis at its source

Synergistic immunomodulation: The dual-target design enables both pathogenic B-cell clearance and modulation of innate immune responses, potentially achieving more durable disease remission

IMM0306 Achieves Systematic Positive Progress in Autoimmune Disease Field

The development pipeline of IMM0306 in autoimmune diseases is advancing comprehensively with positive outcomes. From demonstrating superior efficacy and safety in SLE patients recognized by top-tier international academic conferences, to the regulatory acceptance of the convenient subcutaneous formulation innovation, and now to the IND acceptance for the primary membranous nephropathy indication, IMM0306 is progressively building a differentiated therapeutic pipeline covering multiple B-cell-mediated autoimmune diseases. This systematic progress not only validates the broad potential of the CD47×CD20 dual-target mechanism in autoimmunity but also establishes a solid foundation for the company's subsequent development of additional autoimmune indications.

Dr. Wenzhi Tian, Founder, Chairman, CEO, and CSO of ImmuneOnco, stated:

"IMM0306 has already demonstrated promising therapeutic potential in lupus nephritis. The acceptance of this IND application expands its scope to primary membranous nephropathy, reflecting our commitment to deepening our presence in the autoimmune disease field. PMN patients have long faced limited treatment options, and we believe IMM0306's innovative mechanism will bring new therapeutic hope to this patient population. We will actively advance clinical studies to provide superior treatment options for patients as early as possible."