December 9, 2025 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco", Hong Kong Stock Exchange code: 01541.HK) today announced that the company presented data from its Phase I/II clinical study of amulirafusp alfa (IMM0306), a proprietary bispecific antibody-receptor fusion protein, combined with lenalidomide in relapsed/refractory CD20-positive follicular lymphoma (R/R FL) as a poster presentation at the 67th American Society of Hematology (ASH) Annual Meeting. The data demonstrated that this combination regimen achieved an objective response rate (ORR) of 91.2% and a complete response rate (CR) of 67.6% in patients who had failed at least one prior line of anti-CD20 monoclonal antibody-containing therapy, with an overall manageable safety profile and no risk of cytokine storm.

Key Highlights of ImmuneOnco’s Amulirafusp Alfa (IMM0306) Poster at the 2025 ASH Annual Meeting:

Phase I/II Study Evaluating the Safety and Preliminary Efficacy of Amulirafusp Alfa (IMM0306) in Combination with Lenalidomide in Patients with Relapsed/Refractory CD20-Positive Follicular Lymphoma

Core Summary:

Efficacy Outcomes: Remarkable efficacy data with outstanding complete response rate

As of July 10, 2025, analysis of 34 evaluable patients in Phase II showed:

• ORR of 91.2% (31/34) and CR      rate of 67.6% (23/34)

• Median follow-up of 9.02      months; median progression-free survival (PFS) not yet reached; 6-month      PFS rate of 91.2% (95% CI: 75.1-97.1)

• In the poor-prognosis anti-CD20-refractory subgroup      (n=18), ORR remained high at 88.9% with a CR rate of 66.7%

Safety Summary: Overall manageable safety profile with no cytokine storm risk

Among 47 safety-evaluable patients (9 from Phase Ib and 38 from Phase II):

• Favorable safety profile      with no cases of cytokine release syndrome (CRS) observed, representing a      major breakthrough for CD47-targeted agents

• Treatment-related serious      adverse events (SAEs) occurred in 23.4% of patients

• Only 4.3% (2/47) of      patients discontinued treatment due to treatment-related adverse events      (TRAEs)

• No TRAE-related deaths were reported

Study Conclusion:

Investigators noted that IMM0306 combined with lenalidomide demonstrated unprecedented high response rates, deep and durable responses, and an excellent safety profile in R/R FL patients. The absence of cytokine release syndrome (CRS) circumvents a common safety risk associated with this class of immunotherapy, while maintaining robust efficacy even in anti-CD20-refractory populations. This ongoing Phase I/II study provides a promising new immunotherapeutic strategy for this currently incurable disease with limited treatment options after relapse.

The IMM0306 poster presented at the 2025 ASH Annual Meeting is now available on ImmuneOnco’s Investor Relations webpage at:
https://cn.immuneonco.com/investor/promote/index.html#JInformation

Phase III Study of Amulirafusp Alfa (IMM0306) Combined with Lenalidomide in R/R FL Approved by CDE

Building on the positive results from the Phase I/II study, the Phase III clinical trial protocol for IMM0306 in combination with lenalidomide in relapsed/refractory follicular lymphoma received official approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration on November 27, 2025. This milestone marks the official entry of this innovative therapy into the registrational clinical study phase. ImmuneOnco plans to further validate the efficacy and safety of IMM0306 in the Phase III trial to provide a safer and more effective treatment option for patients.

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

In the autoimmune disease space, IMM0306 has also achieved significant breakthroughs. At the American College of Rheumatology (ACR) Annual Meeting held in Chicago, USA on October 28, 2025, the company presented the latest results from the Phase Ib/II clinical study of IMM0306 in systemic lupus erythematosus (SLE) via poster presentation (data cutoff: September 10, 2025). The study showed that the drug demonstrated favorable safety and tolerability at both 0.8 mg/kg and 1.2 mg/kg dose levels, with positive results in reducing disease activity indices and improving biomarkers. The 1.6 mg/kg dose cohort is currently being actively enrolled, with the potential for even better efficacy. These findings further validate the cross-therapeutic-area value of IMM0306 as a potential novel treatment for B-cell mediated autoimmune diseases.

Dr. Wenzhit Tian, Founder, Chairman, CEO and Chief Scientific Officer of ImmuneOnco, stated:

"We are delighted to share the latest research findings of IMM0306 at ASH, a premier international academic stage. Patients with relapsed/refractory follicular lymphoma face severe treatment challenges. Our bispecific antibody innovative therapy has shown breakthrough potential in earlier studies, achieving not only an ORR of over 90% but also a near 70% CR rate in heavily pretreated R/R FL patients, particularly with no observed cytokine release syndrome (CRS). This gives us hope for transforming the treatment landscape of this disease. With the approval of the Phase III registrational clinical study, we look forward to advancing this innovative therapy to market as quickly as possible to deliver tangible survival benefits to patients."

Dr.  Julie Wu, Chief Medical Officer of ImmuneOnco, stated:

"The latest research findings presented at this year's ASH demonstrate the breakthrough potential of IMM0306 in R/R FL patients, with an ORR exceeding 90%, a CR rate near 70%, durable efficacy, and an overall favorable tolerability profile. Based on these positive and robust data, we are accelerating the design and implementation of the pivotal Phase III registrational study with a scientifically rigorous protocol to further validate the efficacy and safety of this combination therapy. We look forward to providing patients with R/R FL a new and valuable treatment option as early as possible to address unmet medical needs."