远大医药(00512)核药"Go Global"战略再获重磅进展。据远大医药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 值得注意的是，远大医药正积极与中外专家合作开发钇[90Y]微球注射液的其他适应症，并将采用"中美双报"的国际化 注册路径，促进该产品的全球市场拓展。 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。DOORwaY ...

本集团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，板块全球员 工超过 900 人，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，本集团已实现了全球化的核药产业链布局。 本集团联合 Sirtex Medical Pty Ltd 并与 Telix Pharmaceutical Limited 和 ITM Isotope Technologies Munich SE 合作，搭建了具有国际化一流水准的肿瘤介入研发平台和放射性核素偶联药物(RDC)研发平台。围 远大医药(00512)发布公告，本集团的联营公司 Sirtex Medical Pty Ltd 的 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)或其他肝转移等多重适应症，涵盖的原发 性 ...

格隆汇9月8日丨远大医药(00512.HK)公告,集团的联营公司SirtexMedicalPtyLtd的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」)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。 ...

本集团联合 Sirtex Medical Pty Ltd 并与 Telix Pharmaceutical Limited 和 ITM Isotope Technologies Munich SE 合作，搭建了具有国际化一流水准的肿瘤介入研发平台和放射性核素偶联药物(RDC)研发平台。围 绕肿瘤诊疗一体化的治疗理念，目前在研发注册阶段已储备 15 款创新产品，涵盖 68Ga、177Lu、 131I、90Y、89Zr 在内的 5 种放射性核素，覆盖了肝癌、前列腺癌、肾癌、脑癌等在内的 7 个癌种;早 期研发阶段以 RDC 药物为主，产品储备已达 12 款。在产品种类方面，涵盖诊断和治疗两类核素药 物，为患者提供多适应症治疗选择、多手段且诊疗一体化的全球领先的抗肿瘤方案。目前，本集团在核 药抗肿瘤诊疗板块已有五款创新 RDC 获批开展注册性临床研究，其中四款已进入 III 期临床阶段，包 括诊断前列腺癌的产品 TLX591-CDx、治疗前列腺癌的产品 TLX591、诊断透明细胞肾细胞癌产品 TLX250-CDx 以及治疗胃肠胰腺神经内分泌瘤(GEP-NETs) 的产品 ITM-11。此外，全球创新、基于放射 性核素 ...

Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* 本集團全球創新放射性產品 SIR-Spheres®釔[ 90Y]微球注射液 在歐洲獲批新增適應症 本公告乃遠大醫藥集團有限公司(「本公司」，連同其附屬公司統稱「本集團」)之董事 會(「董事會」)自願刊發。 董事會欣然公告，本集團之聯營公司 Sirtex Medical Pty Ltd 的 SIR-Spheres®釔[ 90Y]微球 注射液（「易甘泰®」）近日在歐洲獲批新適應症的 CE 標誌認證，用於肝癌患者治療。 此次批准新增適應症使該療法的適用範圍在原有的不可切除肝細胞癌(「HCC」)和不可 切除結直腸癌肝轉移(「mCRC」)的基础上，扩展到不可切除肝內膽管癌(「ICC」)、神 經內分泌瘤引起的肝轉移(「mNET」)或其他肝轉移等多重適應症，涵蓋的原發性肝癌 和繼發性肝轉移的分類更全面。此外，近期美國食品藥品監督管理局(「FDA」)批准了 SIR-Spheres®釔[ 90Y]微球注射液新增 HCC 適應症，釔[ 90Y]微球注射液在歐美兩大市場 取得的註冊里程碑，進一步推動該產品在不可切除肝癌治療領域的全方位覆蓋 ...

远大医药(00512)盘中涨超4%，截至发稿，涨4.45%，报9.38港元，成交额7296.02万港元。 中金指出，25H1远大医药收入61.07亿港币，同比+1.0%，剔除汇率影响同比+2.0%；归母净利润11.69亿 港币，超该行预期，主要由于收入超预期。公司核药抗肿瘤板块收入4.22亿港币，剔除汇率影响同比 +105.5%，主要由于国内易甘泰快速放量。此外，报告期内易甘泰获FDA批准用于原发性肝细胞癌，成 为全球首个获批原发性肝细胞癌和结直肠癌肝转移的内放射治疗产品。RDC方面公司临床推进顺利， TLX-591CDx完成三期临床入组，TLX591、ITM-11等产品加入国际多中心III期临床试验，自研创新核 药GPN02006亮相国际会议。 消息面上，近日，浦江泌尿肿瘤学术大会暨上海市抗癌协会泌尿肿瘤专委会年会在上海举行，国内外泌 尿肿瘤领域顶尖专家齐聚一堂，远大医药在会上重磅发布"尿路上皮癌早筛早诊项目"，并带来专题报告 《尿路上皮癌精准诊疗与泌尿肿瘤核药研发进展》，集中展示公司在早筛早诊、精准诊疗与核药创新的 系统布局与科研实力。近年来，远大医药持续践行科技创新，已构筑雄厚的创新研发实力及兼具广度与 ...

智通财经APP获悉，远大医药(00512)盘中涨超4%，截至发稿，涨4.45%，报9.38港元，成交额7296.02万 港元。 消息面上，近日，浦江泌尿肿瘤学术大会暨上海市抗癌协会泌尿肿瘤专委会年会在上海举行，国内外泌 尿肿瘤领域顶尖专家齐聚一堂，远大医药在会上重磅发布"尿路上皮癌早筛早诊项目"，并带来专题报告 《尿路上皮癌精准诊疗与泌尿肿瘤核药研发进展》，集中展示公司在早筛早诊、精准诊疗与核药创新的 系统布局与科研实力。近年来，远大医药持续践行科技创新，已构筑雄厚的创新研发实力及兼具广度与 深度的创新布局，并已进入创新业务兑现期，公司"Go Global"创新战略发展势头正盛。 中金指出，25H1远大医药收入61.07亿港币，同比+1.0%，剔除汇率影响同比+2.0%；归母净利润11.69亿 港币，超该行预期，主要由于收入超预期。公司核药抗肿瘤板块收入4.22亿港币，剔除汇率影响同比 +105.5%，主要由于国内易甘泰快速放量。此外，报告期内易甘泰获FDA批准用于原发性肝细胞癌，成 为全球首个获批原发性肝细胞癌和结直肠癌肝转移的内放射治疗产品。RDC方面公司临床推进顺利， TLX-591CDx完成三期临床入 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 呈交日期: 2025年9月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00512 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | | 增加 / 減少 (-) | | | | | | HKD | | | | 本月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | 本月底法定/註冊股本總額： HKD 1,000,000,000 第 1 頁 共 10 頁 v 1.1 ...

Core Viewpoint - The company is strategically focusing on the nuclear medicine sector, with a comprehensive and diversified product layout, aiming to capture market share in a rapidly growing market projected to reach $21.9 billion by 2029, with a CAGR of 16.4% from 2024 to 2029 [1] Group 1: Nuclear Medicine Sector - The company has established a global full industry chain layout in targeted anti-tumor drugs, with its core product, Yttrium-90 microsphere injection (Egan Tai), being the first nuclear medicine for liver cancer treatment in China, having treated nearly 2,000 patients [1] - The company’s domestic sales revenue for the core product is expected to reach HKD 500 million in 2024, representing a year-on-year increase of 140% [1] - The company has formed a pipeline of 12 clinical registrations through acquisitions and independent research, covering various cancers, with 4 domestic pipelines entering clinical phase III [1] Group 2: Respiratory and Critical Care Business - The revenue from the respiratory and critical care segment increased by 26.9% year-on-year [2] - The company’s innovative sepsis drug STC3141 has shown significant efficacy in clinical trials, with a notable reduction in SOFA scores in the treatment group compared to the placebo group, indicating a potential breakthrough in sepsis treatment [2] - The successful launch of STC3141 is expected to enhance the company’s international competitiveness in critical care treatment [2] Group 3: Traditional Pharmaceutical Sector - The traditional pharmaceutical sector remains solid, with a focus on nuclear medicine, cardiovascular precision intervention, pharmaceutical technology, and biotechnology [2] - In the first half of 2025, the company achieved revenue of HKD 6.11 billion, a year-on-year increase of 1.0%, and a net profit of HKD 1.17 billion, a year-on-year decrease of 26.1% [2] - The pharmaceutical technology segment accounted for 63.0% of total revenue, with key products in various therapeutic areas [2] Group 4: Valuation and Growth Potential - The company is positioned as a domestic leader in nuclear medicine and high-end formulations, with a comprehensive pipeline covering multiple cancer indications [3] - The company is valued at a PE of 17 times for 2025, which is lower than the average PE of comparable companies at 22 times [3] - Projected net profits for the company are expected to reach HKD 2.021 billion, HKD 2.347 billion, and HKD 2.756 billion for 2025, 2026, and 2027 respectively, with corresponding PEs of 17, 14, and 12 times [3]

Investment Rating - The report initiates coverage with a "Buy" rating for Grand Pharmaceutical (0512.HK) [7]. Core Views - Grand Pharmaceutical is positioned as a leading player in the nuclear medicine and high-end formulation sectors, with a comprehensive pipeline and a focus on innovative drug development. The company is expected to achieve significant growth driven by its nuclear medicine products and a robust traditional pharmaceutical segment [6][7]. Summary by Sections 1. Innovation Leading Nuclear Medicine Development - The company has established a comprehensive industrial chain covering research, production, and commercialization in nuclear medicine and precision intervention fields [11]. - Grand Pharmaceutical's core product, Yttrium-90 microsphere injection (易甘泰®), is the first approved nuclear medicine for liver cancer treatment in China, with a significant market presence [11][14]. - The nuclear medicine segment is expected to grow rapidly, with projected sales of 500 million HKD in 2024, reflecting a year-on-year increase of 140% [6]. 2. Nuclear Medicine Pipeline Entering Harvest Phase - The global nuclear medicine market is projected to grow at a compound annual growth rate (CAGR) of 16.4%, reaching 21.9 billion USD by 2029 [6][25]. - The company has a rich pipeline with 12 clinical candidates, including four in Phase III trials, targeting various cancers such as prostate and kidney cancer [6][11]. - The report highlights the potential of STC3141, a novel treatment for sepsis, which has shown significant efficacy in clinical trials [6][7]. 3. Financial Performance and Forecast - The company achieved a revenue of 61.1 billion HKD in the first half of 2025, with a year-on-year growth of 1.0%, while the net profit was 11.7 billion HKD, down 26.1% year-on-year [14][18]. - The report forecasts net profits of 20.21 billion HKD, 23.47 billion HKD, and 27.56 billion HKD for 2025, 2026, and 2027, respectively, with corresponding price-to-earnings (P/E) ratios of 17, 14, and 12 [7][14]. - The traditional pharmaceutical segment remains stable, contributing 63% of total revenue, with key products in respiratory and critical care showing solid growth [18][20]. 4. Competitive Positioning - Grand Pharmaceutical's valuation is attractive, with a 2025 P/E ratio of 17, lower than the average of comparable companies at 22 [7]. - The company has established a global sales network covering over 50 countries, demonstrating its international competitiveness [22][24]. - The report emphasizes the strategic acquisitions and partnerships that have strengthened the company's market position and product offerings [11][22].