Shanghai, China – March 4, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“ImmuneOnco,” HKEX Stock Code: 01541.HK) today announced that the Investigational New Drug (IND) application for its proprietary subcutaneous formulation of Amouravfop alfa (IMM0306S), for the treatment of Systemic Lupus Erythematosus (SLE), has been officially approved by China’s National Medical Products Administration (NMPA). This milestone marks a significant breakthrough in ImmuneOnco’s innovative drug development within the autoimmune disease sector.

Formulation Innovation Reshaping the SLE Treatment Landscape

IMM0306S is a subcutaneous formulation of Amouravfop alfa (IMM0306), the world’s first CD47×CD20 dual-target specific molecule to enter clinical development. Developed on ImmuneOnco’s proprietary “mAb-Trap” technology platform, this differentiated biologic is being advanced simultaneously for oncology and B-cell-mediated autoimmune indications. At the American College of Rheumatology (ACR) Annual Meeting in Chicago in October 2025, ImmuneOnco presented updated data from the Phase Ib/II study of intravenous IMM0306 in patients with moderate-to-severe active SLE. The results showed SRI-4 response rates at 24 weeks of 71.4% and 80.0% in the 0.8 mg/kg and 1.2 mg/kg dose groups, respectively. Patients demonstrated significant clinical improvements, including marked reductions in anti-dsDNA antibodies and normalization of complement C3/C4 levels. Notably, the drug exhibited a favorable safety profile with no observed cytokine release syndrome (CRS) or serious infection events. Compared to intravenous infusion, the subcutaneous IMM0306S offers distinct clinical advantages:

Enhanced Safety: Subcutaneous administration significantly lowers peak plasma concentrations, reducing the incidence of infusion-related reactions and improving overall tolerability.

Improved Convenience and Flexibility: By eliminating the need for intravenous access, the subcutaneous route simplifies administration and shortens treatment time. This paves the way for outpatient or potential home-based self-administration, greatly enhancing patient adherence and treatment flexibility.

Broadening Autoimmune Portfolio Demonstrates Platform Strength

The IND approval for IMM0306S in SLE underscores ImmuneOnco’s strategic expansion in the autoimmune space. Leveraging the versatility of the “mAb-Trap” platform, IMM0306 has achieved critical milestones across a diverse range of indications, building a robust product pipeline: IgG4-Related Disease (IgG4-RD): IND approved Primary Membranous Nephropathy (PMN): IND accepted Systemic Lupus Erythematosus (SLE): Phase Ib/II ongoing Neuromyelitis Optica Spectrum Disorder (NMOSD): Phase Ib/III ongoing Lupus Nephritis (LN): Phase II approved Primary Sjögren’s Syndrome (pSS): IND accepted These advancements validate the scalability and commercial potential of ImmuneOnco’s technology platform, reflecting the company’s commitment to addressing significant unmet medical needs.

Parallel Advancement in Hematologic Malignancies

In the oncology sector, based on positive Phase I/II data, the Phase III trial protocol for IMM0306 in combination with lenalidomide for Relapsed/Refractory Follicular Lymphoma (R/R FL) was approved by the Center for Drug Evaluation (CDE) in November 2025. Data presented at the 67th American Society of Hematology (ASH) Annual Meeting revealed that this combination regimen achieved an Objective Response Rate (ORR) of 91.2% and a Complete Response (CR) rate of 67.6% in patients who had failed prior anti-CD20 monoclonal antibody therapy. The regimen demonstrated a manageable safety profile with no cytokine storm events, offering a promising new immunotherapy strategy for R/R FL patients.

“The IND approval for IMM0306S, alongside our rapid progress in indications such as IgG4-RD and PMN, represents a pivotal step in translating our innovative therapies into tangible patient benefits,” said Dr. Tian Wenzhi, Founder, Chairman, CEO, and CSO of ImmuneOnco. “Subcutaneous administration not only enhances convenience and reduces the burden of hospital visits but also optimizes safety and tolerability. With significant unmet needs remaining in SLE and other autoimmune diseases, we are committed to delivering more effective, safer, and accessible treatment options through continuous innovation.”