国元国际：宜明昂科-B(01541)重获IMM2510全球权利 海外研发有望加速推进

Core Viewpoint - Company regained global rights for IMM2510 and IMM27M, enhancing its control over overseas clinical development and accelerating global development pace. The company is a global innovator in CD47 fusion proteins with significant potential in oncology, autoimmune diseases, and cardiovascular applications. The current market capitalization is only HKD 2.7 billion, indicating a severe undervaluation, and it is recommended to pay active attention to the company [1]. Group 1: Event and Rights Recovery - The company terminated the agreement with Axion, reclaiming global development and commercialization rights while allowing Axion to gradually conclude its clinical development activities. This termination does not affect the USD 35 million upfront and milestone payments already received from Axion [2]. - Due to significant delays and challenges faced by Axion in development progress, the company regained global rights for IMM2510 and IMM27M, allowing it to take the lead in overseas clinical research and accelerate the global development pace [3]. Group 2: Clinical Data and Efficacy - At the 2025 World Conference on Lung Cancer (WCLC), data for the PD-L1xVEGF bispecific antibody (IMM2510) showed an objective response rate (ORR) of 35.3% (6/17) among 17 evaluable patients with sq-NSCLC, with a disease control rate (DCR) of 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). The ORR of 35.3% outperformed similar VEGF/PD-(L)1 bispecific antibodies, which had ORRs of 33% and 19%, respectively, while the PFS of 9.4 months ranks among the best in its class [4]. - The company's PD-L1xVEGF bispecific antibody has clear differentiation advantages, with IgG1 Fc capable of activating ADCC, aiming to induce direct killing of PD-L1+ tumor cells. Compared to other PD-(L)1xVEGF bispecific antibodies, its VEGF blocking mechanism is broader, potentially leading to superior efficacy. With regained overseas R&D rights, the company is expected to significantly accelerate overseas clinical studies and simplify future business development negotiations, leveraging its differentiation advantages to attract multinational corporations [5]. Group 3: Safety and Pipeline - Among 23 enrolled patients, common ≥3 grade treatment-related adverse events (TRAEs) included thrombocytopenia (8.7%), lymphopenia (8.7%), and infusion-related reactions (8.7%). The safety profile of IMM2510 as a monotherapy is manageable. The company is also actively advancing clinical trials for IMM2510 in combination with chemotherapy, IMM27M, IMM01, and ADC for various solid tumor indications. An IND application for refractory solid tumors has been approved in the U.S. [6]. - The company has a rich pipeline with significant product potential and broad business development opportunities. The CD47CD20 bispecific antibody (IMM0306) is in Phase Ib clinical trials, showing an 85.7% (6/7) response rate in the 0.8 mg/kg group and 87.5% (7/8) in the 1.2 mg/kg group for SLE patients. IMM01 (CD47 fusion protein) is progressing well in a Phase III trial for CMML, with mid-term data analysis expected in the second half of next year. The clinical trial for IMM72 targeting pulmonary arterial hypertension (PAH) commenced patient recruitment in August 2025, with all enrollments completed, indicating high R&D efficiency [7].