中证报中证网讯(王珞)远大医药10月9日晚公告称，公司全球创新温度敏感性栓塞剂产品GPN00289在中 国开展的用于原发性肝癌经动脉化疗栓塞的注册性临床研究，于近日完成了全部患者入组。GPN00289 是一款获得国家药监局创新型医疗器械资质认定的温度敏感性栓塞材料。 手术切除是治疗早期肝癌的首选方法，但由于肝癌发病隐匿，早期症状不明显或不典型，早诊困难，不 足30%的肝癌患者在初诊时适合根治性治疗，治疗棘手，因此预后较差。 GPN00289结合了液体栓塞和固体栓塞的优势，集载药和栓塞为一体，可弥补现有TACE治疗手段的缺 陷同时，基于GPN00289的载药特性，该产品除了可以与现有化疗药物进行联用外，还有望与公司的内 放射性治疗药物易甘泰钇[90Y]微球注射液进行联用。 远大医药表示，未来将积极推进GPN00289的全球注册开发，致力于在中国及海外市场实现该产品与易 甘泰钇[90Y]微球注射液的战略联动，形成产品的协同效应，持续深耕全球肝癌治疗领域的科技创新， 进一步深化公司核药抗肿瘤诊疗板块的产业布局。 公告显示，临床上针对中晚期肝癌患者最经典的治疗手段是经导管动脉化疗栓塞术(TACE)，常规TACE 主要 ...

根据公告，GPN00289具有温度响应且可塑高的特点，可随温度的变化发生液固相转变，对大小不同、 形状各异的血管都能进行栓塞。同时，该产品还具有可降解特性，可使得血管获得多次治疗机会。值得 注意的是，GPN00289还具有载药功能，除了可以与现有化疗药物进行联用外，还有望与远大医药放射 性治疗药物易甘泰®钇[90Y]微球注射液进行联用。 公告还指出，远大医药拥有GPN00289的全球权益，公司未来将积极推进GPN00289的全球注册开发，致 力于在中国及海外市场实现该产品与钇[90Y]微球注射液的战略联动，形成产品的协同效应，持续深耕 全球肝癌治疗领域的科技创新。 目前布局栓塞剂的药企较少。远大医药已在该领域构筑了创新产品矩阵并形成领先优势，若未来公司 GPN00289在国内及海外市场顺利获批上市，有望进一步强化公司在肝癌治疗领域的核心竞争力。 肿瘤介入是远大医药核药抗肿瘤诊疗板块中重点布局的战略方向之一，公司已在核药抗肿瘤诊疗领域深 耕多年，已在该领域实现研发、生产、配送、销售等多个环节的全方位布局，并以波士顿、成都为核心 的研发基地，波士顿、法兰克福、新加坡、成都所在的生产基地以及覆盖全球50多个国家和地 ...

远大医药(00512)核药抗肿瘤诊疗板块再传捷报！10月9日，远大医药发布公告称，公司全球创新温度敏感性栓塞剂产品GPN00289在中国开展的用于原发性 肝癌经动脉化疗栓塞的注册性临床研究已于近日完成全部患者入组。据悉，GPN00289已获得国家药监局创新型医疗器械资质认定，该产品本次临床进展是 远大医药在肿瘤介入方向上的又一次重大的研发进展，进一步深化了公司在肝癌治疗领域的布局。 深化肝癌治疗领域布局，创新产品矩阵夯实全球竞争力 GLOBOCAN2022年数据显示，肝癌全球新发病例约87万，死亡病例约76万。我国国家癌症中心2024年全国癌症报告显示，2022年中国新发肝癌约37万例(占 全球42.5%)，死亡病例约32万例(占全球42.1%)，占比均居全球首位。 根据公告，GPN00289具有温度响应且可塑高的特点，可随温度的变化发生液固相转变，对大小不同、形状各异的血管都能进行栓塞，且能有效防止侧支循 环的形成，对动脉血流的阻断更完全、更持久有效，适用于各种富血管性实质脏器肿瘤，特别是肝脏富血管的良性及恶性肿瘤的栓塞治疗。同时，该产品还 具有可降解特性，可使得血管获得多次治疗机会，并减少持久栓塞造成的不 ...

Core Viewpoint - The study identifies AKR1B1 as a key regulatory enzyme in metabolic reprogramming and a potential biomarker and therapeutic target for hepatocellular carcinoma (HCC), suggesting that targeting AKR1B1 can reverse systemic therapy resistance in HCC [3][7]. Group 1: Research Findings - HCC is a major subtype of liver cancer and a leading cause of cancer-related deaths globally, with high incidence and mortality rates [2]. - The research team established HCC cell lines with multidrug resistance characteristics, observing enhanced metabolic activity in these cells [5]. - Multi-omics analysis revealed that glucose-lipid and glutathione metabolic pathways are overactive, playing critical roles in supporting tumor cell proliferation and survival [5]. Group 2: Mechanism of Resistance - The study constructed a metabolic reprogramming map for resistant HCC cells, identifying AKR1B1 as a key regulatory factor that maintains resistance by modulating energy metabolism and enhancing stress tolerance [5]. - The expression level of AKR1B1 is closely related to drug resistance and poor prognosis in HCC patients, highlighting its predictive value [5]. Group 3: Therapeutic Implications - The combination of Epalrestat, a clinically approved AKR1B1 inhibitor, with standard therapy (Lenvatinib) significantly alleviated resistance in HCC [7]. - The findings provide new insights into the mechanisms of resistance in HCC and lay the theoretical foundation for developing new predictive biomarkers and therapeutic strategies to overcome resistance [7].

Core Viewpoint - The article discusses the challenges faced by patients with liver cancer and highlights the innovative Y-90 resin microsphere selective internal radiation therapy as a promising treatment option that can improve patient outcomes and potentially allow for curative surgery [2][9]. Group 1: Patient Experiences - Zhou Wei was diagnosed with colorectal cancer liver metastasis, with a significant tumor size of approximately 6.9 cm x 7.6 cm, and faced severe pain and deterioration after chemotherapy [1]. - Yu Chengyi, diagnosed with primary liver cancer, experienced ineffective chemotherapy and significant side effects, leading to a rejection of further treatment [1]. - Both patients and their families expressed a sense of urgency in seeking effective treatment options to prolong life and improve quality of life [7][8]. Group 2: Treatment Options - Traditional therapies often have significant side effects and limited effectiveness for larger tumors, with only 20% to 30% of liver cancer patients eligible for surgical resection [3][9]. - Y-90 therapy is a precise treatment method that delivers radiation directly to the tumor's blood supply, minimizing damage to surrounding healthy liver tissue [6][9]. - The treatment has shown promise in converting initially unresectable tumors into operable ones, providing hope for patients with advanced liver cancer [6][9]. Group 3: Clinical Recognition and Guidelines - Y-90 therapy has been recognized in international clinical guidelines as a treatment for primary liver cancer and colorectal cancer liver metastases, with endorsements from various medical organizations [10]. - In China, the therapy has been included in national health guidelines and is increasingly covered by insurance, improving accessibility for patients [11]. Group 4: Future Outlook - The article emphasizes the need for increased awareness and training among medical professionals regarding Y-90 therapy to enhance its availability and effectiveness for more patients [11]. - The positive outcomes observed in patients who underwent Y-90 therapy suggest a shift in the treatment landscape for liver cancer, potentially leading to better survival rates and quality of life [12].