当前，全球核药抗肿瘤诊疗领域正以前所未有的速度迈向"诊疗一体化"时代。 作为全球仅有的四家成功实现创新核药全球商业化应用的制药企业之一，远大医药（00512）近期在核药抗肿瘤诊疗 板块接连取得里程碑式进展，标志着其全球化商业布局进一步加速： 公司自主研发的重磅全球创新放射性核素偶联药物GPN01530，近日获得美国FDA批准开展用于诊断实体瘤的I/II期临 床研究，实现了自研产品的"硬核出海"；同时，用于前列腺癌诊断的TLX591-CDx中国III期临床试验也取得了积极的 顶线结果，并成功达到了主要临床终点。 除核药领域的绝对优势外，远大医药在多个优势领域的差异化创新发展同样捷报频传： 公司近期布局的全球首款用于紧急治疗I型过敏反应的肾上腺素鼻喷雾剂Neffy （优敏速 ）近期在国内获批上市，填补 了国内院外急救市场的空白；此外，公司1.1类中药创新药GPN01360国内II期临床研究成功达到临床终点，在抑郁症 治疗中展现出显著的疗效与安全性优势，为抑郁症治疗提供了"中国方案"。 这一系列突破，不仅验证了远大医药在多赛道上的先发优势，更揭示了其以核药板块为代表的"Go Global"全球化创新 发展下更深层的 ...

当前，全球核药抗肿瘤诊疗领域正以前所未有的速度迈向"诊疗一体化"时代。 作为全球仅有的四家成功实现创新核药全球商业化应用的制药企业之一，远大医药（00512）近期在核药抗肿瘤诊疗 板块接连取得里程碑式进展，标志着其全球化商业布局进一步加速： 公司自主研发的重磅全球创新放射性核素偶联药物GPN01530，近日获得美国FDA批准开展用于诊断实体瘤的I/II期临 床研究，实现了自研产品的"硬核出海"；同时，用于前列腺癌诊断的TLX591-CDx中国III期临床试验也取得了积极的 顶线结果，并成功达到了主要临床终点。 除核药领域的绝对优势外，远大医药在多个优势领域的差异化创新发展同样捷报频传： 公司近期布局的全球首款用于紧急治疗I型过敏反应的肾上腺素鼻喷雾剂Neffy®（优敏速®）近期在国内获批上市，填 补了国内院外急救市场的空白；此外，公司1.1类中药创新药GPN01360国内II期临床研究成功达到临床终点，在抑郁 症治疗中展现出显著的疗效与安全性优势，为抑郁症治疗提供了"中国方案"。 这一系列突破，不仅验证了远大医药在多赛道上的先发优势，更揭示了其以核药板块为代表的"Go Global"全球化创新 发展下更深层的 ...

Core Viewpoint - The company, YuanDa Pharmaceutical, is experiencing significant advancements in its nuclear medicine pipeline, particularly with the innovative radiopharmaceutical TLX591-CDx for prostate cancer diagnosis, which has shown promising results in clinical trials and is approaching the new drug application stage [1][4]. Group 1: Clinical Trial Results - TLX591-CDx has demonstrated a high diagnostic rate with a positive predictive value (PPV) of 94.8% overall, and a PPV of 100.0% for recurrent tumors in the prostate bed and non-bone metastatic tumors [4][5]. - The product's PET imaging has shown significant clinical implications for early diagnosis in suspected biochemical recurrence of prostate cancer, potentially providing critical treatment time windows for patients [4]. Group 2: Market Potential - TLX591-CDx has already been approved in multiple countries, including the US, Australia, and Canada, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a growth of over 25% [6][7]. - The success of TLX591-CDx in clinical trials in China marks a crucial step in building a comprehensive prostate cancer nuclear medicine product portfolio for the company [7]. Group 3: Product Pipeline and Industry Position - The company has a robust pipeline with 16 innovative products in the research and registration phase, covering various radioactive isotopes and multiple cancer types, indicating a strong commitment to integrated cancer diagnosis and treatment [11]. - YuanDa Pharmaceutical has established a full industry chain layout in nuclear medicine, encompassing research, production, and sales, which enhances its global competitiveness and operational efficiency [11][15]. Group 4: Future Outlook - The company aims to leverage its first-mover advantage and comprehensive industry capabilities to expand its market share in the global nuclear medicine sector, contributing to the advancement of China's nuclear medicine industry on the international stage [16].

TLX591-CDx在中国Ⅲ期临床试验的成功，也意味着远大医药在构建"诊疗一体化"的前列腺癌核药产品组合上迈出了关键 一步。在前列腺癌治疗方面，公司另一创新RDC产品TLX591已在中国获批加入国际多中心Ⅲ期临床研究。未来，两款产品组 合，有望为中国前列腺癌患者带来更为精准、高效的诊疗方案，并将在商业上形成强大的协同效应，释放巨大的市场价值，巩 固远大医药在核药领域的综合优势。 据悉，前列腺癌是我国男性群体中常见的癌症类型，且随着人口老龄化加剧等原因，我国前列腺癌患者的发病率和病死率 呈明显上升趋势。据弗若斯特沙利文数据，到2030年我国前列腺癌发病率或将超过16.5万例，同期我国前列腺癌药物市场规模 有望达到约376亿元。 本报讯 （记者张敏）12月21日，港股上市公司远大医药集团有限公司（以下简称"远大医药"）发布的公告显示，公司用于 诊断前列腺癌的创新RDC药物TLX591-CDx（Illuccix®，gallium Ga68 PSMA-11）在中国进行的Ⅲ期临床试验已取得积极的顶 线结果，并成功达到了主要临床终点。 根据公告，TLX591-CDx是一款全球创新、基于放射性核素-小分子偶联技术的靶向前列 ...

智通财经APP获悉，近日，中国医药创新领域迎来一项具有标杆意义的进展——远大医药(00512)自主研发的全球创新放射 性核素偶联药物(RDC)GPN01530正式获得FDA批准在美国开展用于诊断实体瘤的I/II期临床研究。 此举不仅意味着远大医药在成纤维细胞活化蛋白(FAP)这一明星靶点上的布局取得国际认可，更体现了公司在国际化临床开 发与注册申报上的综合实力，这也将成为公司后续推进其他创新药全球化布局的重要里程碑。未来若GPN01530开发顺利， 该产品有望成为破解实体瘤诊疗困境的重要突破口，凭借显著的产品优势重塑实体瘤诊疗格局，抢占全球领先的市场地 位，并为全球患者带来新的希望。 布局十亿美元级靶点，BIC惠及全球超千万患者 远大医药GPN01530并非寻常意义上的又一款创新核药，其特殊性源于产品靶点背后的泛实体瘤应用前景、所突破的技术瓶 颈以及所承载的"诊疗一体化"愿景，这也使得该产品成为企业在核药领域差异化竞争的核心抓手，更有望成为中国创新核 药出海的标杆范例。 公告显示，GPN01530优化了FAP配体的结构，提高了其在肿瘤组织中的摄取，同时降低其在正常组织中的摄取。临床前研 究结果显示，与其它FA ...

Core Viewpoint - The strategic cooperation agreement between Shengxiang Biotechnology Co., Ltd. and BeiGene (Guangzhou) Innovation Technology Co., Ltd. marks a significant acceleration of Shengxiang's "integrated diagnosis and treatment" strategy [1] Group 1: Cooperation Goals - The collaboration aims to achieve full-link synergy in early screening, precise drug selection, efficacy monitoring, and safety assessment in key areas such as oncology, metabolism, immune inflammation, and children's growth and development [3] - The partnership will leverage large-scale population sample studies to identify suitable intervention targets and optimal timing, enhancing treatment levels in metabolism and immune inflammation while addressing health management challenges related to children's growth and development [3] Group 2: Technological Synergy - The core support for aligning innovative therapies with patient needs lies in precise diagnostic and treatment technologies, which will enhance innovation efficiency and ensure solutions are more aligned with clinical realities [3] - Shengxiang has initiated the construction of an integrated diagnosis and treatment ecosystem, with Shengxiang Haiji serving as the core platform in biopharmaceuticals, facilitating a strong collaboration with BeiGene's innovative research capabilities [3] Group 3: Implementation Framework - The BeiGene Biopharmaceutical Innovation Center will act as the central hub for collaboration, utilizing existing research support, clinical resources, and industrial incubation capabilities to create a comprehensive cooperation chain from technology exploration to clinical validation and practical application [4] - The partnership extends beyond technical collaboration to include joint exploration in children's health and metabolism, as well as coordinated resource layout in the industry, with the potential to expand global cooperation and promote innovative outcomes to more countries and regions [4]

觅小卫®荣膺「阳光」大奖，其无创早筛技术获行业认可。 在临床价值与市场需求层面，觅小卫®的问世意义重大。胃癌是我国高发癌症之一，全球每年新增病例 中中国占比达43%，但当前我国胃癌早期诊断率不足20%，5年生存率仅35.1%，远低于早期胃癌治疗后 的90%生存率。传统胃镜作为侵入性检查，受医师资源、成本及人群接受度限制，难以实现大规模筛 查。而觅小卫®凭借无创、便捷的优势，大幅提升人群接受度，可覆盖超5亿符合指南定义的胃癌高风 险人群，构建起"无创初筛-内镜精查"的高效筛查体系，既有助于提升早期胃癌检出率，又能降低大规 模筛查的成本与资源消耗，完美契合《"健康中国2030"规划纲要》的癌症防控目标。 持续多维度创新 近日，2025年第九届21世纪大健康产业竞争力研究「阳光」案例评选结果正式揭晓，港股上市企业 Mirxes觅瑞（股票代码：2629.HK）核心产品觅小卫®（英文名：GASTROClear™）凭借突破性技术创 新与重大临床价值，成功斩获"创新药械产品类——「阳光」年度优秀新获批创新医疗器械"大奖，彰显 其在无创胃癌早筛领域的标杆地位。 hi 第 九 届 2 1 世 纪 大健康产业竞争力 11 研究 ...

Major Events - Chuangsheng Group-B (06628) announced updated efficacy data for osemitamab triple therapy in first-line treatment of gastric or gastroesophageal junction adenocarcinoma at ESMO Asia [1] - Strength Development (01277) plans to acquire 100% equity of Taiyuan Shidi for approximately 384 million yuan and acquire Dongzhimen property for a total of 86.33 million yuan [1] - Innovent Biologics (01801) completed a global strategic collaboration with Takeda Pharmaceutical and issued 6.9138 million shares under general authorization [1] - Ascentage Pharma-B (06855) received FDA and EMA approval for global registration of the III phase clinical study of Nilotinib in first-line treatment of Ph+ ALL [1] - Baiao Saitou-B (02315) announced that its business partner IDEAYA received IND approval from the FDA for IDE034 [1] - Jinfang Pharma-B (02595) initiated a registration clinical trial for GFH375 in metastatic pancreatic cancer, marking the first global oral KRAS G12D inhibitor monotherapy controlled chemotherapy III phase study [1] - Xixiangfeng Group (02473) subsidiary signed a business cooperation agreement with Hello Car Rental to develop car rental business in designated cities under a "co-branded store" model [1] - International Commercial Settlement (00147) signed a computer chip sales agreement with Hong Kong Antarctic Light to seize growth opportunities in the IC chip market [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval in the U.S. for GLP-1/GIP receptor dual agonist peptide injection [1] - MIRXES-B (02629) plans to collaborate with Jingtai Technology to build an AI-enabled integrated "diagnosis and treatment" research and industrialization platform [1] - Zhengtong Automotive (01728) plans to invest approximately 816 million yuan to acquire Xiamen Xinda 4S dealership and automotive sales and export business [1] - Guorui Life (00108) intends to acquire 78.3% of Beijing Chunyu Tianxia Software for 269 million yuan [1] - Innovent Biologics (01801) announced that seven innovative products, including new indications, were successfully included in the 2025 National Medical Insurance Drug List [1] - Peijia Medical-B (09996) had its registration application for the TaurusNXT® "non-aldehyde cross-linked" transcatheter aortic valve replacement system accepted by the National Medical Products Administration [1] - Fosun Pharma (02196) had new drugs included in the National Medical Insurance Directory and commercial insurance innovative drug directory [1] - Junshi Biosciences (01877) had Tuoyi® new indications and Junshida® included in the National Medical Insurance Directory [1] - Valiant Biopharma-B (09887) clinical data for LBL-034 was presented at the 67th ASH Annual Meeting [1] - Canfite BioPharma (09926) had all approved indications for five marketed drugs successfully included in the latest National Medical Insurance Drug List [1] - Fuhong Hanlin (02696) had Fuzhuoning® (Citrus Aurantium Extract Capsules) included in the National Medical Insurance Drug List [1] - Green Leaf Pharmaceutical (02186) had five new products successfully included in the 2025 National Medical Insurance Drug List or commercial insurance innovative drug directory [1] - Yinnuo Pharmaceutical-B (02591) core products were included in the National Medical Insurance Drug List [1] Operating Performance - Poly Real Estate Group (00119) reported contract sales of approximately 47.7 billion yuan in the first 11 months, a year-on-year decrease of 8.45% [2] - GAC Group (02238) reported November automobile sales of approximately 179,700 units, a year-on-year decline of 9.72% [2] - Xiehe New Energy (00182) reported November equity power generation of 697.23 GWh, a year-on-year increase of 7.77% [2]

Core Viewpoint - The strategic collaboration between Mirxes and Jingtai Technology aims to integrate their strengths in early cancer detection and drug development, creating a comprehensive "diagnosis and treatment integration" solution for high-incidence cancers in Asia [1] Collaboration Model - The partnership focuses on building a closed-loop ecosystem of "detection + research" [2] - Mirxes will act as a "frontline detection and risk assessment expert" utilizing its leading position in blood-based miRNA cancer screening [3] - Jingtai Technology will serve as an "intelligent drug discovery engine" leveraging quantum physics, AI, and robotic experimentation [3] - Both companies plan to create a disease database focused on the Asian population to drive the discovery of new diagnostic markers and therapeutic targets [3] Strategic Intent - This collaboration signifies Mirxes' strategic shift from solely "early diagnosis" to a broader "diagnosis and treatment integration" approach [4] - By closely aligning with upstream drug development platforms, the company aims to participate in higher-value treatment segments, enhancing its competitive barriers and customer loyalty [5] Fundamental Support - Mirxes' strategic advancement is backed by improving fundamentals [6] - Recent business expansions include inclusion in the Hang Seng Composite Index, endorsement from Malaysia's sovereign fund, and obtaining key market access qualifications [7] - The company reported a revenue of $10.5 million in the first half of the year, with core early screening business revenue growing by 50% year-over-year [7] - Gross margin improved significantly from 49% to 67.6%, indicating strong product capability and cost control [7] - Cash reserves reached $108 million, providing financial flexibility for R&D collaboration and market expansion [7] Investment Perspective - Mirxes currently exhibits strong growth in core business and a clear long-term strategy [8] - Short-term certainty is based on the commercial progress of its gastric cancer screening and the effectiveness of its high-margin business model [9] - Long-term potential is enhanced by collaborations with major players like Watson and Jingtai, which open avenues for extending from diagnostic data to treatment [9] Conclusion - The strategic partnership between Mirxes and Jingtai Technology represents a forward-looking move to break through the limitations of the early screening industry and tap into the larger precision medicine market [11] - The company is at a critical juncture of "performance realization" and "model transition," necessitating attention to both existing business growth and the potential value creation from the new ecosystem [12]

谅解备忘录项下的合作符合公司与晶泰科技推进早期检测、早期干预以协助每个人活出健康生活的长期 目标，预示着公司从早期检测延伸到早期干预及精准医疗的重要拓展。透过发挥公司与晶泰科技的互补 优势，此项合作将创造协同效应，结合公司积累多年的高质量癌症生物组学数据、其在癌症诊断领域构 建的资源，及在亚太区域的运营优势，以及晶泰科技在生物医药领域深耕多年的AI研发平台、在药物 研发╱消费健康方面的研发经验，以及其多年构建的生物医药大数据收集、清洗、开发的能力，继而共 同研究与产业化一个AI赋能的、创新的，针对亚洲高发癌种，特别是消化道癌的早诊早治解决方案。 MIRXES-B(02629)发布公告，公司近期与晶泰控股有限公司(晶泰科技)订立了一份谅解备忘录，据此， 双方同意整合公司在基因组学技术及其庞大的、以亚洲人群为中心的疾病数据库方面的核心优势，与晶 泰科技领先的AI+机器人的药物发现和研究平台，针对亚洲高发癌种，特别是消化道癌的早期发现与干 预，共建一个AI赋能的、创新的"诊疗一体化"研究及产业化平台，结合诊断与治疗，合作开发早诊早治 解决方案。谅解备忘录自签署之日起生效，有效期为两年，自签署之日起算。 ...