November 27, 2025 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (the "Company", together with its subsidiaries, the "Group", HKEX stock code: 01541.HK) announced that the Phase III clinical trial protocol for its independently developed bispecific molecule, Amulirafusp Alfa (IMM0306), in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma (FL), has been formally approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

Amulirafusp Alfa (IMM0306) in Combination with Lenalidomide

Amulirafusp Alfa (IMM0306) is a bispecific molecule targeting both cluster of differentiation 47 (CD47) and cluster of differentiation 20 (CD20), and is the first CD47 and CD20 dual-targeting bispecific to enter clinical stage globally. Developed based on the Group's proprietary "mAb-Trap" technology platform, IMM0306 blocks the "don't eat me" signal by inhibiting the CD47-SIRPα interaction, enhances Fc-FcγRIIa and Fc-FcγRIIIa interactions to activate macrophages and NK cells, and preferentially binds CD20 over CD47 to effectively eliminate malignant B cells while minimizing toxicity, leading to improved therapeutic outcomes. The Group has established a comprehensive development program for this asset. In early-phase clinical studies, IMM0306 has demonstrated favorable safety and significant clinical efficacy, particularly in relapsed/refractory follicular lymphoma (FL), with the potential to transform the current treatment paradigm.

Follicular lymphoma (FL) is the second most common lymphoma subtype, accounting for 8% to 23% of non-Hodgkin lymphoma (NHL) cases. The vast majority of FL remains incurable with current therapies, and recurrence represents a major therapeutic challenge, with refractoriness increasing with each subsequent line of therapy. In Phase II clinical studies, the IMM0306 plus lenalidomide regimen has demonstrated promising efficacy and a favorable safety profile, establishing a solid foundation for the subsequent Phase III trial. The Group plans to further validate the efficacy and safety of IMM0306 in the Phase III clinical trial to provide patients with a safer and more effective treatment option.

Amulirafusp Alfa (IMM0306) for Systemic Lupus Erythematosus (SLE)

In the autoimmune disease arena, IMM0306 has also achieved significant breakthroughs. At the American College of Rheumatology (ACR) Annual Meeting held on October 28, 2025, in Chicago, USA, the Group presented the latest results from the Phase Ib/IIa clinical trial of IMM0306 in systemic lupus erythematosus (SLE) as a poster presentation (data cutoff: September 10, 2025). The study demonstrated favorable safety and tolerability at both 0.8 mg/kg and 1.2 mg/kg dose levels, with positive outcomes in reducing disease activity indices and improving biomarker profiles. The 1.6 mg/kg dose cohort is currently progressing as planned and is expected to yield enhanced efficacy. These results further validate the cross-therapeutic value of IMM0306 as a potential novel treatment option for B cell-mediated autoimmune diseases.

Statement from Dr. Wenzhi Tian, Founder, Chairman of the Board, CEO and CSO of ImmuneOnco:

"We are deeply honored to receive the CDE's approval for the IMM0306 Phase III clinical trial design. This represents not only a strong affirmation of our R&D team's scientific expertise but also a crucial milestone in delivering new hope to patients with relapsed/refractory follicular lymphoma. As a common indolent lymphoma, FL patients with relapsed/refractory disease face significant therapeutic challenges. The efficacy and safety profile demonstrated by the IMM0306 plus lenalidomide regimen in earlier-phase studies provides a clear rationale for breakthrough potential in this treatment paradigm. We will strictly adhere to CDE requirements and recommendations to meticulously execute the Phase III clinical trial, ensuring scientific rigor, operational excellence, and patient safety, with the goal of delivering a more effective and safer treatment option for relapsed/refractory FL patients at the earliest opportunity."

Statement from Ms. Zhuli Wu, Chief Medical Officer of ImmuneOnco:

"We are delighted that the CDE has approved the IMM0306 Phase III clinical protocol. This important validation of the molecule's clinical potential marks a critical milestone for this program. Building upon the promising efficacy and favorable safety profile demonstrated by the IMM0306 plus lenalidomide regimen, we are fully committed to advancing this pivotal Phase III trial with the aim of bringing a new, safe and effective therapeutic option to patients with relapsed/refractory follicular lymphoma."