Shanghai, China – February 12, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ("ImmuneOnco," Hong Kong Stock Exchange: 01541.HK) announced today that its investigational new drug application (IND) for Amouravfop alfa (IMM0306), a novel CD47×CD20 bispecific molecule developed in-house, has been approved by the National Medical Products Administration (NMPA) for the treatment of IgG4-related disease (IgG4-RD). This marks the world's first regulatory approval to initiate clinical trials of a CD47×CD20 bispecific agent in IgG4-RD, expanding IMM0306 into this challenging autoimmune indication and offering a differentiated dual-target therapeutic approach for patients with substantial unmet medical needs.

Comprehensive Advancement in Autoimmune Disease Pipeline

Amouravfop alfa (IMM0306) is the world's first CD47×CD20 bispecific molecule to enter clinical development, built upon ImmuneOnco's proprietary "mAb-Trap" technology platform. As a differentiated biologic, IMM0306 is being concurrently developed for both oncology and B-cell-mediated autoimmune diseases. Clinical progress in oncology—particularly in B-cell malignancies—has demonstrated a favorable efficacy and safety profile, providing a robust foundation for its expansion into autoimmune indications and enhancing overall development efficiency while mitigating cross-indication development risks.

In systemic lupus erythematosus (SLE), data from the ongoing Phase Ib/II trial presented at the 2025 American College of Rheumatology (ACR) Annual Meeting showed that IMM0306 was well tolerated at doses of 0.8 mg/kg and 1.2 mg/kg, with encouraging signals in reducing disease activity and improving key biomarkers. Enrollment in the 1.6 mg/kg dose cohort is currently underway. These results, recognized at a premier international academic forum, further validate the cross-disease potential of IMM0306 as a novel therapeutic candidate for B-cell-mediated autoimmune disorders.

In parallel, ImmuneOnco has recently submitted an IND application to the NMPA for a subcutaneous formulation of IMM0306, which has been accepted for review. This next-generation delivery method aims to enhance patient convenience and long-term treatment adherence. Combined with prior clinical trial progress or IND submissions across multiple immune-mediated indications—including relapsed/refractory follicular lymphoma (in combination with lenalidomide; Phase III approved), SLE (Phase Ib/II), neuromyelitis optica spectrum disorder (NMOSD; Phase Ib/III), lupus nephritis (LN; Phase II), and primary membranous nephropathy (PMN; IND accepted)—the systematic advancement of IMM0306 in autoimmune diseases underscores the broad therapeutic potential of the CD47×CD20 dual-target mechanism and establishes a solid platform for future expansion into additional autoimmune conditions.

About IgG4-Related Disease (IgG4-RD)

IgG4-RD is a chronic, progressive fibroinflammatory disorder that can affect multiple organs, including the pancreas, bile ducts, salivary glands, lacrimal glands, and retroperitoneal tissues. In severe cases, it may lead to irreversible organ dysfunction or failure. Current treatment options are limited by suboptimal response rates, high relapse rates, and a lack of long-term evidence-based strategies, representing a substantial unmet clinical need. The pathogenesis of IgG4-RD is characterized by aberrant B-cell activation and tissue infiltration by IgG4-positive plasma cells—mechanisms that align precisely with the dual-target action of IMM0306.

The NMPA's approval of the clinical trial application for Amouravfop alfa (IMM0306) in IgG4-RD represents a significant milestone, extending the molecule's therapeutic reach beyond oncology and other autoimmune indications into this complex disease area and offering a novel, mechanism-driven treatment option.

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

"We are delighted to receive NMPA approval for the IND of IMM0306 in IgG4-related disease—a critical milestone in our efforts to address this severely underserved autoimmune condition. Based on the favorable safety profile and potent B-cell depletion observed in our SLE clinical trials, we are confident in the potential of this innovative therapy to benefit a broader spectrum of B-cell-mediated autoimmune diseases. We will rigorously design the upcoming clinical trial to thoroughly evaluate the efficacy and safety of IMM0306 in IgG4-RD, with the goal of delivering a breakthrough treatment to patients as soon as possible."