远大医药(00512)正在深化泌尿诊疗产品战略。通过泌尿领域战略投资落地，纵深布局打开百亿增量空间。 近期，公司与上海颖特微络医疗器械有限公司(以下简称"上海颖特微络")签订合作协议，取得其用于治疗良性前列腺增生(BPH)的蒸汽消融产品VTAS的全球 独家商业化权益，且双方将携手共建联合实验室深化药械研发合作，拓展产业生态版图。 此次战略合作延续了远大医药"产品"和"技术"两手抓的经营思路，形成了"渠道拓展"与"创新协同"并进的新格局。本次合作不仅可推动产品上市后加速渗透 市场，为患者提供更为优质的治疗体验;更通过共建联合实验室，搭建起技术攻坚与成果转化的直通车，使远大医药快速切入潜力巨大的增量市场，让深度 绑定的研究合作助力远大医药实现技术的内化，深化其在泌尿诊疗领域的全球战略布局，为其持续领跑行业奠定坚实基础。 前列腺蒸汽消融技术潜力显著，产品性能优越剑指百亿元市场 前列腺增生(BPH)是一种常见于中老年男性的泌尿系统疾病。有数据显示，BPH发病率随着年龄增加而逐渐升高，60岁以上男性BPH发病率达60%，70~80岁 男性的发病率高达80%~90%，我国目前有超1亿男性受到BPH困扰。且随着人口老龄化的 ...

智通财经APP讯，远大医药(00512)正在深化泌尿诊疗产品战略。通过泌尿领域战略投资落地，纵深布局 打开百亿增量空间。 此次战略合作延续了远大医药"产品"和"技术"两手抓的经营思路，形成了"渠道拓展"与"创新协同"并进 的新格局。本次合作不仅可推动产品上市后加速渗透市场，为患者提供更为优质的治疗体验;更通过共 建联合实验室，搭建起技术攻坚与成果转化的直通车，使远大医药快速切入潜力巨大的增量市场，让深 度绑定的研究合作助力远大医药实现技术的内化，深化其在泌尿诊疗领域的全球战略布局，为其持续领 跑行业奠定坚实基础。 前列腺蒸汽消融技术潜力显著，产品性能优越剑指百亿元市场 前列腺增生(BPH)是一种常见于中老年男性的泌尿系统疾病。有数据显示，BPH发病率随着年龄增加而 逐渐升高，60岁以上男性BPH发病率达60%，70~80岁男性的发病率高达80%~90%，我国目前有超1亿 男性受到BPH困扰。且随着人口老龄化的加剧，预计其患者规模还将进一步攀升。 针对该病症，目前传统的治疗方案主要包括药物治疗以及侵入性手术，如电刀切除、激光剜除等，虽较 为有效，但仍存在影响性功能、植入物风险、术中出血和手术时间长等问题。 近期 ...

Core Viewpoint - The Hong Kong International Biotechnology Forum and Exhibition (BIOHK) 2025 serves as a significant platform for industry leaders to discuss the future of biotechnology, with a focus on the global strategy of the pharmaceutical company YuanDa Pharmaceutical [1][3]. Group 1: Company Strategy and Globalization - YuanDa Pharmaceutical is recognized as a leading global player in nuclear medicine, sharing its global strategy at the BIOHK 2025 forum [3][6]. - The company is implementing a "Go Global" strategy, focusing on global research, production, and sales to enhance the value of innovative products [3][10]. - YuanDa has achieved significant milestones in its nuclear medicine development, with its product Yttrium-90 microsphere injection being used in over 150,000 patients across more than 50 countries [6][10]. Group 2: Product Development and Market Expansion - The company has received CE mark certification for new indications of its innovative product, expanding its treatment scope to include multiple types of liver cancer, which is expected to double its market potential [6][10]. - YuanDa is advancing its pipeline with 15 innovative products in development, covering various cancers and utilizing five types of radioactive isotopes [7][9]. - The company is actively pursuing a "dual filing" strategy in the U.S. and China, with several products entering international Phase III clinical trials [9][10]. Group 3: Research and Production Capabilities - YuanDa has established a comprehensive global network for nuclear medicine, with research and production bases in Boston and Chengdu, and a sales network covering over 50 countries [11][13]. - The company has built a state-of-the-art production facility in Chengdu, recognized as one of the most automated and comprehensive nuclear medicine factories globally [11][13]. - YuanDa's global innovation strategy includes five research platforms and eight research centers, with a robust pipeline of 133 projects in various stages of development [13].

Core Viewpoint - The Hong Kong International Biotechnology Forum and Exhibition (BIOHK) 2025 serves as a significant platform for industry leaders to discuss the future of biotechnology, with a focus on the global strategy of Yuan Da Pharmaceutical in nuclear medicine [1][3]. Group 1: Company Strategy - Yuan Da Pharmaceutical is recognized as a leading global nuclear medicine company, sharing its unique global development strategy at the forum [3][5]. - The company is implementing a "Go Global" strategy, focusing on global R&D, production, and sales to enhance the long-term value of innovative products [3][5][9]. Group 2: Market Expansion - The recognition of Chinese innovative drugs is increasing globally, with a notable rise in the number of oral presentations by Chinese pharmaceutical companies at the ASCO conference, from 25 in 2023 to 84 in 2025 [3]. - In the first half of 2025, the transaction value of innovative drug licensing exceeded the total for 2024, indicating strong innovation capabilities [3]. Group 3: Product Development - Yuan Da Pharmaceutical has achieved significant breakthroughs in nuclear medicine, with its innovative product, Yttrium-90 microsphere injection, being used in over 50 countries and for more than 150,000 patients [5]. - The product is the first and only FDA-approved treatment for unresectable hepatocellular carcinoma (HCC) and colorectal cancer liver metastases, recently receiving CE mark certification for additional indications [5]. Group 4: R&D Pipeline - The company has 15 innovative products in the R&D registration phase, utilizing five types of radioactive isotopes to target eight different cancers [6][8]. - Yuan Da is advancing its "dual filing" strategy in the U.S. and China, with several products entering international multi-center Phase III clinical trials [8]. Group 5: Global Infrastructure - Yuan Da Pharmaceutical has established a comprehensive global sales network covering over 50 countries, supported by R&D bases in Boston and Chengdu, and production facilities in multiple international locations [10][12]. - The company’s Chengdu facility is noted for being one of the most automated and comprehensive nuclear medicine production plants globally, ensuring high-quality product supply [10]. Group 6: Long-term Vision - The company aims to deepen its global market penetration and brand development through its ongoing "Go Global" strategy, addressing unmet medical needs worldwide [12].

Core Viewpoint - The approval of the Blue Whale TM intracranial aneurysm embolization support frame marks a significant advancement in treatment options for intracranial aneurysms in China, enhancing the company's position in the high-end medical device market [1] Group 1: Company Developments - The company has been deeply engaged in the high-end medical device sector for many years, focusing on "precision treatment" and has established a comprehensive layout around three main areas: pathway management, structural heart disease, and heart failure [1] - The company has over 30 products in its high-end medical device portfolio, with 23 products approved for market in China under the pathway management category and 1 product approved for structural heart disease [1] - The company is actively advancing clinical registration for other products in China, with plans for phased and tiered launches of innovative products to drive stable growth in this business segment [1] Group 2: Global Expansion - The company is also expanding its global footprint in the field of cardiovascular precision interventional diagnosis and treatment, having established technical collaborations with clinical centers or R&D platforms in multiple countries including the USA, Canada, Germany, Italy, and Switzerland [1] - The company has successfully built a comprehensive "passive + active" innovative device platform, which is expected to enhance its capabilities in the global market [1] - With the ongoing implementation of its "Go Global" strategy, the company aims to develop this segment into a leading global platform for cardiovascular precision interventional diagnosis and treatment, further enhancing its overall value [1]

近日，远大医药(00512)颅内动脉瘤辅助栓塞支架蓝鲸TM获国家药监局批准上市(国械注准20253131589)。据悉，蓝鲸TM是我国国产首款编织型动脉瘤辅助 栓塞支架，不仅丰富了远大医药心脑血管精准介入诊疗领域的产品种类，更凸显出公司前瞻性布局的成效，同时也将为我国颅内动脉瘤治疗带来全新的治疗 选择。 国产首款编织型动脉瘤辅助栓塞支架，性能优越惠及千万患者 颅内动脉瘤作为脑内"不定时炸弹"，是引发脑出血的最常见原因，且一旦出血破裂致死率极高。《颅内动脉瘤显微手术治疗专家共识(2025版)》数据显示， 我国颅内动脉瘤的总体患病率达1.3%-7.6%，我国35-75岁人群的未破裂颅内动脉瘤的患病率约为7%，其破裂导致的动脉瘤性蛛网膜下腔出血在30天内的病 死率更是高达43%。据弗若斯特沙利文数据，我国颅内未破裂动脉瘤患病人数预计将于2028年增长至8,951.4万人。 据灼识咨询报告，2020年我国神经介入手术量约为16.14万台，预计将以28.6%的年复合增长率增长至74.05万台。在手术量的大幅增加下，神经介入医疗器 械的市场规模也正不断扩容，预计将在2026年增长至175亿元。 庞大的患者数字背后，是巨大 ...

智通财经APP获悉，近日，远大医药(00512)颅内动脉瘤辅助栓塞支架蓝鲸TM获国家药监局批准上市(国械注准20253131589)。据悉，蓝鲸TM是我国国产首 款编织型动脉瘤辅助栓塞支架，不仅丰富了远大医药心脑血管精准介入诊疗领域的产品种类，更凸显出公司前瞻性布局的成效，同时也将为我国颅内动脉瘤 治疗带来全新的治疗选择。 国产首款编织型动脉瘤辅助栓塞支架，性能优越惠及千万患者 具体而言，蓝鲸TM采用了独特的编织设计以及显影技术提供了一定程度的血流分流，以实现大于95%的血管造影动脉瘤闭塞。蓝鲸TM辅助支架全系列为镍 钛单丝16头编织设计，显著提升支架径向支撑及血管贴壁。此外，蓝鲸TM全系80%可回收释放，实现了可控输送和精准植入。基于独特coil缠绕显影技术等 多方面临床优势，蓝鲸TM颅内动脉瘤辅助栓塞支架未来有望使更多患者得到更为精准的颅内动脉瘤介入治疗方案，未来市场潜力十分可观。 前瞻布局百亿神经介入器械市场，打造高端器械产品集群 据灼识咨询报告，2020年我国神经介入手术量约为16.14万台，预计将以28.6%的年复合增长率增长至74.05万台。在手术量的大幅增加下，神经介入医疗器 械的市场规模也正不 ...

易甘泰自中国获批上市后快速放量，截至2024年末，该产品已累计治疗近2000例患者，2024年实现近5 亿港元销售收入，同比增速超140%。 远大医药在核药抗肿瘤诊疗板块已实现了研发、生产、配送、销售等多个环节的全方位布局，以波士 顿、成都为核心的研发基地，波士顿、法兰克福、新加波、成都所在的生产基地以及覆盖全球50多个国 家和地区的销售网络为基础，已实现全球化的核药产业链布局。 公司位于中国四川省成都市温江区的远大医药放射性药物研发及生产基地已于2025年6月底正式投入运 营。该基地覆盖"同位素制备-核药研发-生产临床-商业化"全链条，形成从早期研发到临床转化到上市销 售的全生命周期管理能力，14条高标准GMP生产线实现多品种、规模化制备需求。 中证报中证网讯(王珞)远大医药9月8日晚公告称，公司创新放射性产品SIR-Spheres钇[90Y]微球注射液 (易甘泰)近日在欧洲获批新适应症的CE标志认证，用于肝癌患者治疗。此次批准新增适应症使该疗法的 适用范围在原有的不可切除肝细胞癌(HCC)和不可切除结直肠癌肝转移(mCRC)的基础上，扩展到不可 切除肝内胆管癌(ICC)、神经内分泌瘤引起的肝转移(mNET ...

来源：环球网 远大医药核药"Go Global"战略再获重磅进展。 在取得亮眼的商业化成绩的同时，远大医药也在积极拓展钇[90Y]微球注射液在全球解锁更多的适应 症。今年7月，基于DOORwaY90临床试验的突破性中期数据，美国FDA提前正式批准钇[90Y]微球注射 液新增适应症，用于不可切除HCC，且未限制肿瘤直径大小，该产品成为全球首个且唯一获FDA批准 用于不可切除HCC和结直肠癌肝转移双重适应症的选择性内放射治疗产品。DOORwaY90中期临床结果 显示，钇[90Y]微球注射液治疗不可切除HCC的客观缓解率高达98.5%；所有可评估患者均显示治疗反 应，提示局部肿瘤控制率达到100%；此外，中位缓解持续时间超过300天。 适应症的持续拓展不仅为易甘泰®注入了全新的增长动力，更使其以"一药多能"的特性构建起管线级价 值，相当于以单产品之力实现了多产品管线的治疗覆盖，真正达成"一个产品匹敌一个管线"的战略突 破。 伴随着适应症范围的显著扩大，钇[90Y]微球注射液的适用患者将有望成倍增加，市场空间将实现战略 级的扩增，将开启"泛癌种治疗"新阶段。同时，接连取得的海外注册里程碑也彰显了远大医药优秀的海 外临 ...

经济观察网 远大医药（00512.HK）9月8日公告，公司重磅创新核药SIR-Spheres®钇[90Y]微球注射液 （易甘泰®）近日在欧洲获批新适应症的CE标志认证，用于肝癌患者治疗。本次批准新增适应症使钇 [90Y]微球注射液的适用范围在原有的不可切除肝细胞癌（HCC）和不可切除结直肠癌肝转移 （mCRC）的基础上，扩展到不可切除肝内胆管癌（ICC）、神经内分泌瘤引起的肝转移（mNET）或 其他肝转移等多重适应症，涵盖的原发性肝癌和继发性肝转移的分类更全面｡ ...