Core Viewpoint - The company Yiming Anke-B (01541) has received approval from the National Medical Products Administration of China for clinical trials of IMM01 (Tida-paisip) for the treatment of atherosclerosis, which has positively impacted its stock price [1] Group 1: Company Developments - Yiming Anke-B's stock price rose over 10% in early trading, currently up 8.63% at HKD 6.67, with a trading volume of HKD 11.1965 million [1] - The company holds global intellectual property and commercialization rights for IMM01 (Tida-paisip) and has a patent family that includes authorized patents in China, the United States, Japan, and the European Union [1] Group 2: Research and Development Insights - Guoyuan International reported that the company has regained global rights for IMM2510 and IMM27M, which will accelerate the pace of global development [1] - Clinical data for IMM2510 is reported to be excellent with good safety and significant differentiation advantages [1] - The company’s R&D pipeline is expanding, enhancing its risk resistance, with promising clinical efficacy data for the CD47CD20 dual antibody (IMM0306), which is expected to become a major drug in the autoimmune field [1] Group 3: Market Valuation - The company is recognized as a global innovator in CD47 fusion proteins, with a rich pipeline and broad application prospects in oncology, autoimmune diseases, and cardiovascular fields [1] - Currently, the market capitalization is only HKD 2.7 billion, indicating a significant undervaluation, and it is recommended to pay close attention to the company [1]

Core Viewpoint - The termination of the licensing and collaboration agreement between Yiming Anke (01541.HK) and Instil Bio (TIL.US) for the development of two cancer drugs, IMM2510 and IMM27M, is a significant setback for Yiming Anke, which had potential revenues exceeding $2 billion from this deal [2][3][5]. Group 1: Agreement Details - The collaboration agreement, established in August 2024, allowed Yiming Anke to retain rights in Greater China while granting Axion Bio exclusive global development and commercialization rights [2][3]. - Yiming Anke received a total of $35 million in payments from the collaboration, including a $5 million upfront payment and milestone payments [3][5]. - The agreement was initially seen as a major milestone for Yiming Anke's international strategy, particularly as PD-(L)1/VEGF dual antibodies were highly sought after in the international business development market [3][5]. Group 2: Reasons for Termination - The primary reason for the termination was the slow progress of clinical trials, with only three patients enrolled in the U.S. clinical trial as of January 2026, which was significantly below expectations [3][4]. - Yiming Anke's founder indicated that the choice of collaboration partner had limitations, contributing to the slow development pace [4][5]. Group 3: Future Strategy and Market Reaction - Following the termination, Yiming Anke plans to regain control over the global rights to the two drugs, which may accelerate their development pace [5][6]. - The market reacted negatively to the news, with Instil Bio's stock price dropping over 50% following the announcement [2]. - Yiming Anke aims to pursue new business development opportunities with multinational companies and is considering partnerships with mid-sized firms for further development [6].

Core Viewpoint - The company Yiming Pharmaceutical-B (01541.HK) has received approval from the National Medical Products Administration for clinical trials of IMM01 (Tida-pasip), aimed at treating atherosclerosis [1] Group 1: Product Information - The core product IMM01 (Tida-pasip) is an innovative targeted CD47 molecule and is the first SIRPα-Fc fusion protein to enter clinical stages in China [1] - IMM01 (Tida-pasip) utilizes a dual mechanism to activate macrophages by blocking the "don't eat me" signal through interference with the CD47/SIRPα interaction and delivering the "eat me" signal via Fc-gamma (Fcγ) receptor activation [1] - The CD47 binding domain of IMM01 (Tida-pasip) has been specially modified to avoid binding with human red blood cells (RBCs), demonstrating good safety and macrophage activation capabilities [1] Group 2: Regulatory Approvals - The combination of IMM01 (Tida-pasip) with Azacitidine for frontline treatment of Chronic Myelomonocytic Leukemia (CMML) received orphan drug designation from the U.S. Food and Drug Administration (FDA) in November 2023 [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration of China for clinical trials of IMM01 (Tida-paisip) for the treatment of atherosclerosis, marking a significant milestone in its product development [1] Group 1: Product Development - IMM01 (Tida-paisip) is an innovative targeted CD47 molecule and the first SIRPα-Fc fusion protein to enter clinical stages in China [1] - The product activates macrophages through a dual mechanism by blocking the "don't eat me" signal and delivering the "eat me" signal via Fc-gamma receptors [1] - The CD47 binding domain of IMM01 has been specially modified to avoid binding with human red blood cells, enhancing its safety profile [1] Group 2: Regulatory Milestones - IMM01 (Tida-paisip) has been granted orphan drug designation by the FDA for first-line treatment of CMML in combination with Azacitidine as of November 2023 [1] Group 3: Intellectual Property - The company holds global intellectual property and commercialization rights for IMM01 (Tida-paisip), with a patent family that includes granted patents in China, the United States, Japan, and the European Union [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration of China for clinical trials of IMM01 (Tida-pacisib) for the treatment of atherosclerosis, marking a significant milestone in its product development [1] Group 1: Product Development - IMM01 (Tida-pacisib) is an innovative targeted CD47 molecule and the first SIRPα-Fc fusion protein to enter clinical stages in China [1] - The product utilizes a dual mechanism to activate macrophages by blocking the "don't eat me" signal and delivering the "eat me" signal through Fc-gamma receptors [1] - The CD47 binding domain of IMM01 has been specially modified to avoid binding with human red blood cells, enhancing its safety profile [1] Group 2: Regulatory Approvals - IMM01 (Tida-pacisib) has been granted orphan drug designation by the U.S. Food and Drug Administration for first-line treatment of Chronic Myelomonocytic Leukemia (CMML) in November 2023 [1] Group 3: Intellectual Property - The company holds global intellectual property and commercialization rights for IMM01 (Tida-pacisib), with a patent family that includes granted patents in China, the United States, Japan, and the European Union [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因 倚賴該等內容而引致的任何損失承擔任何責任。 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1541） ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 宜明昂科生物醫藥技術（上海）股份有限公司 – 1 – 本集團擁有IMM01（替達派西普）的全球知識產權及商業化權利。截至本公告日 期，就IMM01（替達派西普）而言，本集團擁有一個專利家族，其中包括在中國、 美國、日本及歐盟的已授權專利。 根據香港聯合交易所有限公司證券上市規則第18A.05條的警示聲明：本公司無 法保證能夠成功開發或最終上市銷售IMM01（替達派西普）。本公司股東及潛在 投資者在買賣本公司股份時應謹慎行事。 承董事會命 宜明昂科生物醫藥技術（上海）股份有限公司 自願公告 IMM01（替達派西普）獲國家藥監局批准進行 動脈粥樣硬化治療的臨床試驗 本公告由宜明昂科生物醫藥技術（上海）股份有限公司（「本公司」，連同其附屬 公司統稱「本集 ...

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].

Policy Developments - The National Medical Products Administration (NMPA) is optimizing the review and approval process for urgently needed overseas drugs that have already been marketed, aiming to meet the pressing clinical needs of patients [1] Drug and Device Approvals - Yifan Pharmaceutical's subsidiary received a registration acceptance notice for Yihuang Decoction Granules, which is indicated for kidney strengthening and dampness clearing [2] - Zhenghai Bio announced that it received a medical device registration acceptance notice for a uterine cavity repair membrane, currently in the acceptance stage [3] - Microchip Biotech's Xidabendan Tablets have been approved for sale in Macau, marking an expansion into overseas markets [4] - Heng Rui Medicine's innovative drug Ruirafulpu α injection has been approved for marketing, with no similar products currently approved domestically or internationally, and a cumulative R&D investment of approximately 711 million yuan [5] Capital Market Insights - Bibet reported that it is not yet profitable and has accumulated unremedied losses, with only one product approved and several others in various clinical trial stages, indicating a need for significant ongoing R&D investment [6] - Innovation Medical confirmed that its production and operational status is normal, with no undisclosed significant matters [7][8] Industry Events - Yiming Onco announced the termination of its collaboration agreement with Axion Bio, regaining global development and commercialization rights for two core anti-cancer drugs, with previously received payments unaffected [9] Public Opinion Alerts - The Director of the Jiangxi Provincial Health Commission is under disciplinary review and investigation for serious violations of discipline and law [10]

Core Viewpoint - The termination of the licensing and collaboration agreement between Yiming Anke and Instil Bio regarding IMM2510/AXN-2510 and IMM27M/AXN-27M allows Yiming Anke to regain all rights for global development and commercialization outside Greater China, while Instil Bio retains limited rights to complete its clinical development activities [1][3]. Group 1: Business Development Strategy - Yiming Anke plans to restart global business development efforts, focusing on two main strategies: continuing discussions with multinational pharmaceutical companies (MNCs) that have shown interest in the assets and updating them on the latest clinical data, and seeking medium-sized companies with urgent needs in related fields for potential joint development or collaboration [1][7]. - The company will prioritize the compatibility of potential partners' existing product pipelines with its two assets during the selection process, considering factors such as opportunities for joint development and collaborative advancement [2]. Group 2: Clinical Development and Market Context - IMM2510/AXN-2510 is a novel PD-L1xVEGF bispecific antibody, currently ranked third in domestic development progress, while IMM27M/AXN-27M is a next-generation CTLA-4 antibody designed to enhance ADCC activity. Yiming Anke believes that the combination of these two assets will create a "diamond combination" due to the clear pathways for commercialization and established safety profiles of PD-1 and CTLA-4 related drugs [4][8]. - The clinical progress of IMM2510/AXN-2510 and IMM27M/AXN-27M is crucial for their future success, with a focus on achieving rapid market entry for IMM2510 as a monotherapy and expanding the long-term value and indications for IMM27M [8][9]. Group 3: Financial and Operational Challenges - Instil Bio has faced significant financial challenges, with a reported cash balance of $580.1 million as of September 2025, which limits its ability to advance clinical trials for the licensed products. The company has struggled with fundraising, raising only $66 million net from a public offering [6]. - The slow progress in clinical trials for IMM2510/AXN-2510 and IMM27M/AXN-27M has been attributed to Instil Bio's financial constraints, which have hindered its ability to meet development milestones and continue its business expansion efforts [5][6].