Guoyuan International has initiated coverage on IMMUNEONCO-B (01541), issuing a "Buy" rating with a target price of HK$6.28. This price target implies a potential upside of approximately 83% from the current trading level.

The brokerage's valuation, derived from a discounted cash flow model, sets the target market capitalization at HK$2.711 billion. Revenue forecasts for the years 2026 to 2028 are projected at RMB 0.32 billion, RMB 2.62 billion, and RMB 4.82 billion, respectively.

Key Investment Thesis

The report highlights promising clinical data for the company's CD47xCD20 bispecific antibody, IMM0306, in treating systemic lupus erythematosus. The drug has the potential to become a blockbuster therapy in the autoimmune disease sector. Furthermore, the phase 3 trial for the company's CD47-targeting candidate is progressing smoothly.

Robust Data for IMM0306 in SLE

Data from a Phase Ib trial involving 32 SLE patients, presented at the EULAR 2026 conference, showed the study met its primary endpoint. In the 1.6 mg/kg dose group, an 80% SRI-4 response rate was achieved at Week 24, with the therapeutic effect sustained without attenuation through Week 52. Based on a benefit-risk assessment, doses of 1.2 mg/kg and 1.6 mg/kg have been selected as the recommended Phase 2 dose, with a randomized, double-blind, placebo-controlled Phase II study initiated in April 2026.

A clear dose-response relationship was observed, with SRI-4 response rates of 80% (1.6 mg/kg), 72.7% (1.2 mg/kg), and 71.4% (0.8 mg/kg) at Week 24. Comparative analysis shows this efficacy profile is at the forefront of the current SLE development pipeline, even after accounting for potential overestimation due to the open-label study design. Critically, the sustained efficacy through 52 weeks suggests a potential immune-resetting effect leading to long-term benefits.

The safety profile was favorable, with no dose-limiting toxicities, treatment-related serious adverse events, or treatment discontinuations or deaths due to TRAEs reported in the full cohort. The incidence of Grade 3 or higher TRAEs was 15.6%, primarily transient platelet decreases, which all resolved spontaneously. Notably, no cytokine release syndrome was observed, marking a significant safety advantage over CD3-based bispecifics and CAR-T therapies. The absence of serious infections and maintenance of normal IgG levels provide a safety window for potential long-term treatment.

Strong Profile for CD47 Fusion Protein

The CD47 fusion protein, IMM01, features an engineered IgG1 Fc designed to fully activate macrophages via a dual mechanism while its modified CD47-binding domain avoids binding to red blood cells. The Phase 3 trial for chronic myelomonocytic leukemia has completed enrollment of the required 133 patients for an interim analysis, with data expected in the fourth quarter of this year. Cumulatively, the company's CD47 fusion protein program has involved over 300 patients across trials, demonstrating a favorable efficacy and safety record.

Data for IMM2510 presented at ASCO showed a 35.3% objective response rate in a Phase II trial for later-line lung squamous cell carcinoma in patients who had failed a median of two prior therapies, including immunotherapy. The discontinuation rate was only 3.1%, with no Grade 3 or higher immune-related adverse events reported, highlighting its significant safety advantages. The subcutaneous formulation of IMM2510 received clinical trial approval on July 2, 2026. This dual intravenous and subcutaneous formulation strategy is expected to greatly enhance dosing convenience for patients with advanced cancer.