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]

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].

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].

Core Viewpoint - The company, Yiming Oncology, has reclaimed global rights for IMM2510 (PD-L1/VEGF) and IMM27M (CTLA-4 ADCC+) from Instil Bio, indicating a strategic correction in its licensing approach. This decision allows the company to regain control over its assets and explore new partnerships while managing its development strategy and clinical progress more effectively [1][4]. Group 1: Asset Reclamation - The company has retrieved global rights for IMM2510 and IMM27M, which were previously licensed to Instil Bio for a $50 million upfront payment and additional milestone payments totaling $2 billion. This move is seen as a timely decision to mitigate potential losses due to Instil's slow progress in development [1]. - Instil Bio's slow advancement, with the first patient enrollment in the U.S. not expected until November 2025, raised concerns about its execution capabilities [1]. Group 2: CTLA-4 and Combination Therapy Potential - The IMM27M asset, targeting CTLA-4, has gained renewed attention due to its potential in combination therapies, especially following positive data from BioNTech/OncoC4's new CTLA-4 antibody, Gotistobart. This highlights the significant future potential for combination therapies involving both VEGF/PD-L1 and CTLA-4 [2]. - CTLA-4 as a monoclonal antibody offers flexibility in dosing and administration frequency, which may help reduce safety risks associated with its use [2]. Group 3: CD47 Pipeline and Clinical Progress - The company's core focus includes the CD47 pipeline, particularly the lead product IMM01 (sirpα-Fc fusion protein), which is advancing in Phase III clinical trials for chronic myelomonocytic leukemia (CMML). A mid-term analysis is expected within the year, with promising efficacy and safety data accumulated so far [3]. - The IMM0306 molecule, based on IMM01, is one of the fastest-developing MCE molecules, indicating strategic value in the CD47 space, especially following significant partnerships in the field [3]. Group 4: Autoimmune and Oncology Developments - In the autoimmune sector, IMM0306 has shown promising results in treating systemic lupus erythematosus, with response rates of 71.4% and 80.0% at different dosages, demonstrating its convenience with a dosing schedule of once weekly for four weeks [4]. - In oncology, data presented at the 2025 ASH conference showed a 91.2% overall response rate (ORR) and a 67.6% complete response (CR) rate for IMM0306 in combination with lenalidomide for relapsed refractory follicular lymphoma, with plans for a Phase III trial to start in Q1 2026 [4].

Core Viewpoint - The approval of the clinical research plan for IMM0306 marks a significant advancement in innovative therapies for relapsed/refractory follicular lymphoma, leading to a notable increase in the company's stock price [1] Company Summary - 宜明昂科-B (01541) experienced a stock price increase of over 9%, currently trading at 7.31 HKD with a transaction volume of 10.70 million HKD [1] - The company has received approval from the National Medical Products Administration for the III phase clinical research plan of IMM0306 in combination with lenalidomide for treating relapsed/refractory follicular lymphoma [1] - IMM0306 is the world's first clinical-stage dual-targeting bispecific molecule targeting CD47 and CD20, designed to block the "don't eat me" signal, activating macrophages and NK cells [1] - The drug preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving treatment outcomes [1] - The company holds global intellectual property and commercialization rights for IMM0306 [1]

Core Viewpoint - Yiming Oncology-B (01541) experienced a significant stock increase of over 9%, currently trading at 7.31 HKD, following the approval of its clinical research protocol for IMM0306 by the National Medical Products Administration [1] Group 1: Company Developments - Yiming Oncology announced that it has received approval for the Phase III clinical study of IMM0306 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma [1] - IMM0306 is the world's first dual-targeting bispecific molecule targeting CD47 and CD20, designed to block the "don't eat me" signal, thereby activating macrophages and NK cells [1] - The drug preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, which could enhance treatment outcomes [1] Group 2: Market Reaction - Following the announcement, Yiming Oncology's stock price rose by 7.98%, with a trading volume of 10.70 million HKD [1]

Core Viewpoint - The approval of the III phase clinical research protocol for IMM0306 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma marks a significant advancement in innovative therapies for this condition [1] Group 1 - The company has received approval from the National Medical Products Administration (NMPA) for the clinical study [1] - The study focuses on relapsed/refractory follicular lymphoma, indicating a targeted approach to a specific patient population [1] - This development accelerates the progress of innovative treatments in the field of oncology [1]

Core Viewpoint - The approval of the Phase III clinical study protocol for IMM0306 by the National Medical Products Administration marks a significant advancement in innovative therapies for relapsed/refractory follicular lymphoma [1] Group 1: Company Developments - The company has received approval for the Phase III clinical study of IMM0306 in combination with lenalidomide for treating relapsed/refractory follicular lymphoma [1] - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The company holds global intellectual property and commercialization rights for IMM0306 [1] Group 2: Product Mechanism - IMM0306 works by inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-FcγRIIa and Fc-FcγRIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving treatment outcomes [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the Phase III clinical study of IMM0306 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma, marking a significant advancement in innovative therapies for this condition [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-FcγRIIa and Fc-FcγRIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving treatment outcomes [1] Group 2: Intellectual Property and Commercial Rights - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for a Phase III clinical study of IMM0306 in combination with lenalidomide for the treatment of relapsed/refractory follicular lymphoma, indicating accelerated development of innovative therapies for this condition [1] Group 1: Product Development - IMM0306 is a dual-target bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the activation of macrophages and NK cells while preferentially binding to CD20 to effectively eliminate malignant B cells with minimal toxicity [1] - The company holds global intellectual property and commercialization rights for IMM0306 as of the announcement date [1]