IMMUNEONCO-B (01541) has regained the global rights to IMM2510 and IMM27M, allowing the company to reassume leadership over its overseas clinical development, which is expected to accelerate its global development timeline. The company's R&D pipeline continues to expand, enhancing its risk resilience. As a global innovator in CD47 fusion proteins, it holds broad application prospects in the fields of oncology, autoimmune diseases, and cardiovascular conditions. With a current market capitalization of only HKD 2.7 billion, the company is severely undervalued, and it is recommended for active investor attention. The primary views are as follows: The company entered into a termination agreement with Axion, reclaiming the global development and commercialization rights previously granted, while Axion retains only a limited license to gradually wind down clinical development activities. This termination does not affect the $35 million upfront and milestone payments that IMMUNEONCO has already received from Axion. The company has regained global rights to IMM2510 and IMM27M because its partner, Axion (a wholly-owned subsidiary of Instil Bio), experienced significant delays in development progress and faced challenges in fulfilling its obligations. By reassuming control over overseas clinical development, the company is poised to accelerate its global development pace. Data for IMM2510 shows excellent ORR and PFS. Data for the PD-L1xVEGF bispecific antibody (IMM2510) presented at the 2025 World Conference on Lung Cancer (WCLC) indicated that among 17 efficacy-evaluable sq-NSCLC patients, the objective response rate (ORR) was 35.3% (6/17), and the disease control rate (DCR) reached 76.5% (13/17). The median duration of response (DoR) was 7.59 months (95% CI: 4.07–NA), and the median progression-free survival (PFS) was 9.4 months (95% CI: 1.87–NA). An ORR of 35.3% demonstrates superior efficacy compared to similar VEGF/PD-(L)1 bispecific antibodies, which showed rates of 33% and 19%. A PFS of 9.4 months places it among the leading candidates in the category of VEGF/PD-(L)1 and PD-1/IL-2 bispecific antibodies. IMM2510 possesses significant differentiated advantages. The company's PD-L1xVEGF bispecific antibody has clear differentiated benefits; its IgG1 Fc can activate ADCC, and the ADCC-enhanced antibody is designed to induce direct killing of immunosuppressive PD-L1+ tumor cells. Compared to other PD-(L)1xVEGF bispecific antibodies, its VEGF blockade mechanism is broader, capable of binding multiple VEGF receptor ligands. Although competition in the VEGF/PD-(L)1 bispecific antibody space is intense, the company's structural design offers distinct advantages, potentially leading to superior efficacy. After regaining control of overseas R&D, the company is expected to significantly accelerate its international clinical studies. Furthermore, future business development negotiations will be more streamlined, and its differentiated advantages may attract interest from multinational corporations. IMM2510 demonstrates a favorable safety profile. Among the 23 enrolled patients, common Grade ≥3 treatment-related adverse events (TRAEs) included thrombocytopenia (8.7%), lymphocytopenia (8.7%), and infusion-related reactions (8.7%). The safety profile of IMM2510 monotherapy is considered manageable. The company is also actively advancing clinical trials for IMM2510 in combination with chemotherapy, with IMM27M, with IMM01, and with ADCs across various solid tumor indications. An Investigational New Drug (IND) application for relapsed/refractory solid tumors has already been approved in the United States. The pipeline is rich, with candidates possessing blockbuster potential, offering substantial business development opportunities. 1. CD47/CD20 Bispecific Antibody (IMM0306): In the Phase Ib clinical trial, among 15 efficacy-evaluable SLE patients, 7 were in the 0.8mg/kg dose group and 8 in the 1.2mg/kg dose group. The proportion of patients achieving a reduction of ≥4 points in the SLEDAI-2000 score was 85.7% (6/7) in the 0.8mg/kg group and 87.5% (7/8) in the 1.2mg/kg group. 2. IMM01 (CD47 Fusion Protein): This candidate can fully activate macrophages through a dual mechanism of action. Its CD47 binding domain is specially engineered to avoid binding with red blood cells. The Phase III clinical trial of IMM01 for treating CMML is progressing smoothly, with interim data analysis anticipated in the second half of next year. 3. IMM72: Patient recruitment for the new drug clinical trial of IMM72 for treating pulmonary arterial hypertension (PAH) commenced in August 2025 and has now completed full enrollment, demonstrating high R&D efficiency.
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