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国元国际:宜明昂科-B重获IMM2510全球权利 海外研发有望加速推进
Zhi Tong Cai Jing· 2026-01-08 08:39
Core Viewpoint - Company regained global rights for IMM2510 and IMM27M, enhancing its control over overseas clinical research and accelerating global development pace [1][3] Group 1: Company Developments - Company terminated the agreement with Axion, reclaiming global development and commercialization rights while retaining limited licenses for Axion to wind down clinical activities [2] - The termination does not affect the $35 million upfront and milestone payments already received from Axion [2] Group 2: Product Pipeline and Clinical Data - IMM2510 demonstrated excellent efficacy data at the 2025 World Lung Cancer Conference, with an objective response rate (ORR) of 35.3% and a disease control rate (DCR) of 76.5% among 17 evaluable patients [4] - The median duration of response (DoR) was 7.59 months, and the median progression-free survival (PFS) was 9.4 months, outperforming similar products [4] Group 3: Competitive Advantages - IMM2510 has significant differentiation advantages, including the ability to activate antibody-dependent cellular cytotoxicity (ADCC) and a broader VEGF blocking mechanism compared to competitors [5] - The regained overseas development rights are expected to expedite clinical research and simplify future business development negotiations, potentially attracting interest from multinational corporations (MNCs) [5] Group 4: Safety and Ongoing Trials - The safety profile of IMM2510 is manageable, with common grade ≥3 treatment-related adverse events (TRAEs) reported at 8.7% for thrombocytopenia, lymphopenia, and infusion-related reactions [6] - Company is actively advancing clinical trials for IMM2510 in combination with chemotherapy and other drugs across various solid tumor indications [6] Group 5: Rich Pipeline Potential - The pipeline includes promising candidates such as IMM0306, which showed an 85.7% response rate in the 0.8 mg/kg group for SLE patients, and IMM01, which is progressing well in a Phase III trial for CMML [7] - IMM72 for pulmonary arterial hypertension (PAH) has completed subject recruitment, indicating high research efficiency [7]
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
智通财经网· 2026-01-08 08:35
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].
宜明昂科-B(01541):即时点评:重获IMM2510全球权利,海外研发有望加速推进
Guoyuan Securities2· 2026-01-07 11:32
Investment Rating - The report suggests a positive outlook for the company, indicating that it is significantly undervalued with a market capitalization of only HKD 2.7 billion, and recommends active attention to the stock [8]. Core Insights - The company has regained global rights for IMM2510 and IMM27M, allowing it to accelerate overseas clinical development [2][8]. - Clinical data for IMM2510 shows promising results, with an objective response rate (ORR) of 35.3% and a progression-free survival (PFS) of 9.4 months, outperforming similar products [3]. - The differentiated advantages of IMM2510 include its ability to activate antibody-dependent cellular cytotoxicity (ADCC) and a broader VEGF blocking mechanism, which may lead to superior efficacy compared to competitors [4][8]. - The safety profile of IMM2510 is manageable, with common grade 3 treatment-related adverse events reported at 8.7% [5][6]. - The company has a rich pipeline with significant product potential, including the CD47CD20 bispecific antibody (IMM0306) and CD47 fusion protein (IMM01), both showing promising clinical efficacy [7][8]. Summary by Sections - **Regained Rights**: The company has terminated its agreement with Axion, regaining control over the global development and commercialization rights for IMM2510 and IMM27M, which is expected to enhance the pace of clinical research [1][2]. - **Clinical Data**: The clinical efficacy of IMM2510 is highlighted by its ORR of 35.3% and PFS of 9.4 months, indicating strong performance compared to similar therapies [3]. - **Differentiation**: IMM2510's unique design allows for enhanced immune response and broader action against various VEGF receptors, positioning it favorably in a competitive market [4]. - **Safety Profile**: The safety of IMM2510 is considered acceptable, with manageable adverse events reported during trials [5][6]. - **Pipeline Potential**: The company’s pipeline includes several promising candidates, with ongoing trials indicating strong potential for future growth in various therapeutic areas [7][8].
宜明昂科-B(01541):即时点评:PD-L1xVEGF双抗临床疗效及安全性数据优秀
Guoyuan Securities2· 2025-09-10 09:53
Investment Rating - The report suggests a positive outlook for the company, indicating that the current market capitalization of HKD 57 billion is significantly undervalued, recommending active attention to the stock [6]. Core Insights - The company presented excellent preliminary efficacy and safety data for IMM2510, a PD-L1xVEGF dual antibody, at the 2025 World Lung Cancer Conference, showing an objective response rate (ORR) of 35.3% and a progression-free survival (PFS) of 9.4 months in patients with advanced squamous non-small cell lung cancer (sq-NSCLC) [2][3]. - The safety profile of IMM2510 is manageable, with common grade ≥3 treatment-related adverse events (TRAEs) reported at 8.7% for thrombocytopenia, lymphopenia, and infusion-related reactions [3]. - The company has a rich pipeline with significant product potential, including the CD47CD20 dual antibody (IMM0306) and other candidates, indicating a broad space for business development [4][5]. Summary by Sections Clinical Data - The ORR for IMM2510 was reported at 35.3% (6 out of 17 patients), with a disease control rate (DCR) of 76.5% (13 out of 17). The median duration of response (DoR) was 7.59 months, and the median PFS was 9.4 months [2]. Safety Profile - Among 23 enrolled patients, the common grade ≥3 TRAEs included thrombocytopenia (8.7%), lymphopenia (8.7%), and infusion-related reactions (8.7%), indicating that the safety of IMM2510 is controllable [3]. Pipeline and Development - The company is advancing multiple clinical trials, including a Phase III registration trial for IMM2510 in sq-NSCLC and various combinations with other therapies [3]. The CD47 fusion protein (IMM01) is progressing well in Phase III trials for CMML and cHL, with mid-term data analysis expected next year [5]. Additionally, the new drug IMM72 for pulmonary arterial hypertension (PAH) has received approval and is currently recruiting healthy volunteers [5].