宜明昂科-B(01541)发布公告，本公司于2025年12月31日成功完成IMM01(替达派西普)用于慢性粒-单核 细胞白血病(CMML)一线治疗的III期临床试验的104例患者招募，并预期将于2026年3月底前完成中期分 析所需的132 例患者招募。截至本公告日期，董事会确认本集团的业务营运及临床开发维持正常，且本 集团的业务营运及财务状况并无重大不利变动。 本集团拥有IMM01(替达派西普)的全球知识产权及商业化权利。截至本公告日期，就IMM01(替达派西 普)而言，本集团拥有一个专利家族，其中包括在中国、美国、日本及欧盟的已授权专利。 本集团的核心产品IMM01(替达派西普)是创新靶向CD47的分子。该款产品是中国首个进入临床阶段的 SIRPα-Fc融合蛋白。具有免疫球蛋白G1 (IgG1) Fc的 IMM01(替达派西普)能够通过双重作用机制充分激 活巨噬细胞 — 同时通过干扰CD47/SIRPα相互作用阻断"别吃我"信号，并通过激活巨噬细胞的Fc-gamma (Fcγ)受体传递"吃我"信号。此外，IMM01(替达派西普)的CD47结合结构域经过特别改造能够避免与人 体红细胞(RBC)结合。凭藉差异化 ...

Core Viewpoint - Yiming Anke-B (01541) has seen a significant stock price increase following the approval from the National Medical Products Administration of China for clinical trials of IMM01 (Tadapaxip) for atherosclerosis treatment [1] Group 1: Company Developments - Yiming Anke has received approval for clinical trials of IMM01 (Tadapaxip) for treating atherosclerosis, holding global intellectual property and commercialization rights for this drug [1] - The company possesses a patent family for IMM01, with authorized patents in China, the United States, Japan, and the European Union [1] Group 2: Market Analysis - Guoyuan International's report indicates 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 is recognized as a global innovator in CD47 fusion proteins, with a rich pipeline and promising applications in oncology, autoimmune diseases, and cardiovascular fields [1] - The current market capitalization is only 2.7 billion HKD, indicating a significant undervaluation, and the company is recommended for active monitoring [1]

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 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]

Group 1 - The company has successfully completed the first patient dosing in the IB/II clinical trial of IMM2510 in combination with IMM01 for the treatment of advanced solid tumors, marking a significant milestone in innovative cancer immunotherapy [1] - IMM2510, developed by the company, is a bispecific molecule targeting VEGF and PD-L1, designed to inhibit angiogenesis, reduce tumor size, and enhance immune response sensitivity [1] - The mechanism of IMM2510 includes blocking the PD-L1/PD-1 interaction and inducing antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP), activating T cells, natural killer cells, and macrophages [1] Group 2 - The company has entered into a licensing and collaboration agreement with Axion Bio, Inc., granting the company commercialization rights for IMM2510 in Greater China while allowing Axion Bio, Inc. exclusive rights for research, development, and commercialization outside Greater China [2] - The company's core product, IMM01, is the first SIRPα-Fc fusion protein to enter clinical stages in China, designed to activate macrophages by blocking the "don't eat me" signal and delivering the "eat me" signal [3] - IMM01 has received orphan drug designation from the FDA for first-line treatment of CMML in combination with azacitidine, demonstrating its potential in the market [3] - The company holds global intellectual property and commercialization rights for IMM01, with a patent family that includes granted patents in China, the US, Japan, and the EU [3]

Group 1 - Company has successfully completed the first patient dosing in the Phase IB/II clinical trial of IMM2510 in combination with IMM01 for the treatment of advanced solid tumors, marking a significant milestone in the field of innovative cancer immunotherapy [1] - IMM2510 (Perivalephap α) is a proprietary dual-specific molecule targeting Vascular Endothelial Growth Factor (VEGF) and Programmed Cell Death Ligand 1 (PD-L1), designed to inhibit angiogenesis, reduce tumor size, and enhance tumor cell sensitivity to immune responses [1] - The mechanism of IMM2510 includes blocking the PD-L1/Programmed Cell Death Protein 1 (PD-1) interaction and inducing Fc-mediated Antibody-Dependent Cellular Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP) to activate T cells, natural killer cells, and macrophages [1] Group 2 - The company has entered into a licensing and collaboration agreement with Axion Bio, Inc., granting the company commercialization rights for IMM2510 in Greater China while allowing Axion Bio, Inc. exclusive rights for research, development, and commercialization outside Greater China [2] - The core product IMM01 (Tidapepac) is an innovative molecule targeting CD47, recognized as the first SIRPα-Fc fusion protein to enter clinical stages in China, demonstrating a dual mechanism to activate macrophages [3] - IMM01 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for first-line treatment of Chronic Myelomonocytic Leukemia (CMML) in combination with Azacitidine, showcasing its potential in the market [3] - The company holds global intellectual property and commercialization rights for IMM01, with a patent family that includes granted patents in China, the United States, Japan, and the European Union [3]

Group 1 - Company announced the successful completion of the first patient dosing in the Phase IB/II clinical trial of IMM2510 in combination with IMM01 for the treatment of advanced solid tumors, marking a milestone in innovative cancer immunotherapy [1] - IMM2510 (Pervirafusp alpha) is a dual-specific molecule targeting Vascular Endothelial Growth Factor (VEGF) and Programmed Cell Death Ligand 1 (PD-L1), designed to inhibit angiogenesis, reduce tumor size, and enhance immune response sensitivity [1] - The mechanism of IMM2510 includes blocking the PD-L1/Programmed Cell Death Protein 1 (PD-1) interaction and inducing antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP), activating T cells, natural killer cells, and macrophages [1] Group 2 - The company entered into a licensing and collaboration agreement with Axion Bio, Inc., granting the company commercialization rights for IMM2510 in the Greater China region while allowing Axion Bio, Inc. exclusive rights for research, development, and commercialization outside this region [2] - The core product IMM01 (Tideglusib) is an innovative molecule targeting CD47, being the first SIRPα-Fc fusion protein to enter clinical stages in China, designed to activate macrophages through dual mechanisms [3] - IMM01 has received orphan drug designation from the FDA for first-line treatment of Chronic Myelomonocytic Leukemia (CMML) in combination with Azacitidine, showcasing its potential in the market [3] - The company holds global intellectual property and commercialization rights for IMM01, with a patent family that includes granted patents in China, the United States, Japan, and the European Union [3]

Core Viewpoint - Yiming Anke-B (01541.HK) has successfully completed a placement agreement, raising approximately HKD 345.1 million for various research and operational purposes [1] Group 1: Placement Details - The placement involved the successful allocation of 24.2 million shares at a price of HKD 14.50 per share, representing about 5.94% of the company's issued share capital prior to the placement [1] - The shares allocated account for approximately 6.11% of the total issued H-shares before the placement and about 5.61% and 5.76% of the issued share capital and H-shares, respectively, after the placement [1] Group 2: Use of Proceeds - Approximately 40% of the net proceeds will be allocated to fund the research and development of IMM2510 and IMM27M for the treatment of solid tumors [1] - About 20% will be used for the development of IMM01 (Tideglusib) [1] - Approximately 10% will be directed towards the research of IMM0306 [1] - The remaining 30% will be utilized to supplement the company's working capital and for general corporate purposes [1]