国家药监局：进一步提升监管效能推进生物制品分段生产试点 4月21日消息，近日，国家药监局党组成员、副局长黄果带队赴广东，走访部分医药企业、科研单位和 药品审评检查部门，围绕加强监管和服务高质量发展深入调研。黄果对广东省医药产业创新发展和质量 安全监管工作予以肯定，强调要落实全面深化药品监管改革要求，进一步提升监管效能，推进生物制品 分段生产试点；健全"一支队伍、一张网络和一套标准"，高质量实施药品补充申请改革试点；探索优化 前置服务，巩固提升跨国企业在华投资发展信心，支持引导骨干企业、国家重点实验室等加大创新药物 研发力度。 国家医保局：开展医保影像云索引上传试点工作 政策动向 国家卫健委：无资质机构严禁开展产前筛查 4月21日，国家卫健委发布《关于进一步加强产前筛查服务管理的通知》，明确医疗机构开展产前筛查 须经卫健行政部门许可，从业人员必须通过专业考核并取得相应资质证书。无资质机构及人员严禁开展 相关服务。 4月21日，国家医保局办公室发布关于开展医保影像云索引上传试点工作的通知。根据《放射检查类医 疗服务价格项目立项指南（试行）》中的影像资料上传和价格减收要求，征集有条件的地区开展医保影 像云索引上传试 ...

Core Insights - The company announced a significant breakthrough in the development of GPN02006, a global innovative radiolabeled drug conjugate (RDC) for diagnosing hepatocellular carcinoma (HCC) [1] - The clinical results of the investigator-initiated trial (IIT) were publicly presented at the Chengdu 2025 Future XDC New Drug Conference, marking a milestone in the company's oncology nuclear drug development efforts [1] - GPN02006 is expected to become the world's first RDC product targeting the GPC-3 marker for HCC diagnosis [1]

智通财经APP获悉，核药龙头再添重磅产品新进展！4月21日，远大医药(00512)公布其用于诊断肝细胞癌(HCC)的全球创新放射性核素偶联药物(RDC) GPN02006在中国开展的研究者发起的临床研究（IIT临床研究）取得了里程碑式突破，并于成都2025未来XDC新药大会中公开发表了临床结果—— GPN02006给药后30分钟即可实现高质量显像，其显像背景信号极低，可实现HCC病灶特异性高摄取，且拥有优异的诊断对比度，临床优势显著。 GPN02006可为临床医生制定个体化诊疗方案提供强有力的分子影像学依据，充分满足肝细胞癌临床快速诊断需求，并有望改善当前HCC患者早期诊断率不 足及复发转移监测困难的临床现状。 此次研究进展标志着远大医药在抗肿瘤核药研发领域再次取得重大突破，进一步巩固了公司在放射性诊疗一体化领域的领先地位。 前瞻性布局GPC-3靶点，积极临床结果体现产品潜力 根据公告，GPN02006是远大医药合作开发的全球创新、基于放射性核素-抗体偶联技术的靶向磷脂酰肌醇蛋白聚糖3 (GPC-3)的诊断型放射性药物，其对 GPC-3靶点具有高特异性和高亲和力，且安全性好，适用对HCC的精准诊断，GPC3在 ...

目前，临床上HCC诊断的金标准依旧是病理组织学和/或细胞学检查，但由于该方法为有创性检查，使 用受到诸多条件限制，因此一般不作为首选的初诊方式。目前主流的首选诊断方法主要是血清学肿瘤标 志物检测和常规的影像学检测，但是我国HCC患者大多伴随基础肝病，超过80%的HCC发生在肝硬化基 础上，不典型增生结节或肝硬化背景使肝脏占位鉴别诊断困难而"辨不准"，因此，HCC 的精准诊断仍 面临着较大的挑战。近年来，以核医学为代表的分子影像检测技术发展迅速，其应用放射性药物与疾病 发生发展过程中的生物标志物特异性结合或参与生物代谢，在分子水平实现无创可视和量化评价而用于 疾病诊断，最常用的是氟-18-氟代去氧葡萄糖(F-FDG)PET 显像，然而，F-FDG 并非肿瘤特异性显像 剂，且由于HCC细胞膜葡萄糖转运蛋白表达低，文献报告F-FDG PET显像对HCC诊断的灵敏度仅为 36%-70%，美国国立综合癌症网路(National Comprehensive Cancer Network，NCCN)发布的指南不推荐 F-FDG 用于HCC诊断和评估。因此，开发高靶向HCC特异性分子探针是HCC精准个体化诊疗的重要发 展趋势 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對 其準確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 自願性公告 董事會欣然公告，本集團與武漢睿迪輻生物科技有限公司、傑科（天津）生物醫藥有 限公司合作開發的用於診斷肝細胞癌（hepatocellular carcinoma，HCC）的全球創新 放射性核素偶聯藥物「( RDC」) GPN02006 在中國開展的研究者發起的臨床研究（IIT 臨床研究），近日取得了里程碑式突破，並於成都 2025 未來 XDC 新藥大會中公開 發表了臨床結果。該研究是一項前瞻性、單中心、診斷性的臨床研究，在超過 80 例 臨床懷疑或者確診的 HCC 患者中，使用 GPN02006 並進行正電子發射斷層成像/電 腦斷層掃描（PET/CT）或正電子發射斷層成像/磁共振成像（PET/MRI）顯像，以初 步評估該產品對 HCC 的診 ...

Investment Rating - The industry investment rating is "Outperform the Market" [1][50]. Core Insights - Eli Lilly's first oral small molecule GLP-1 drug, Orforglipron, has successfully completed Phase 3 clinical trials, which is expected to change the landscape of weight loss medications [3][4]. - The ACHIEVE-1 trial showed that Orforglipron significantly reduced HbA1c levels by 1.3% to 1.6% from a baseline of 8.0% after 40 weeks, with over 65% of patients achieving HbA1c levels ≤6.5% [3][4]. - Patients receiving the highest dose of Orforglipron lost an average of 7.3 kg, indicating potential for further weight loss [4]. - Eli Lilly plans to submit a global application for Orforglipron for weight management by the end of this year and for type 2 diabetes treatment in 2026 [4][5]. Summary by Sections Industry Overview - The successful Phase 3 trial of Orforglipron positions it as a potential second oral GLP-1 drug in the U.S., following Novo Nordisk's Rybelsus [5]. Investment Strategy - Focus on "innovation," "overseas expansion," "equipment upgrades," and "consumer recovery" as key investment themes [7]. - Recommended companies include innovative drug developers and those with strong overseas market potential [7]. Key Companies to Watch - **Nocera Health**: Expected to achieve over 1 billion yuan in revenue from its core product, with a projected 49% year-on-year growth [8]. - **Sihuan Pharmaceutical**: Strong fundamentals with a stable growth outlook, particularly in the ADC market [11]. - **China Biopharmaceutical**: Rapid revenue growth with a focus on innovative products [13]. - **Aier Eye Hospital**: Benefiting from increasing demand in ophthalmology and ongoing overseas expansion [22]. Market Performance - The pharmaceutical sector saw a decline of 0.36% last week, while the broader market index rose by 0.59% [25][36].

智通财经APP讯，近日，港股科技创新型医药企业远大医药(00512)传来利好，公司在放射性核素偶联药物(RDC)领域的重要战略合作伙伴Telix Pharmaceuticals Limited (ASX: TLX)公布了用于治疗胶质母细胞瘤(脑癌)的全球创新RDC产品TLX101的海外II期临床试验(IPAX-Linz研究)的初步结果，证实 了患者的获益。这是远大医药在核药抗肿瘤诊疗领域全球布局的一项重要进展。 TLX101产品潜力可观，已获FDA孤儿药认定 据悉，TLX101自由通过血脑屏障进入大脑，并靶向胶质母细胞瘤过度表达的L型氨基酸转运蛋白1 (LAT-1)精准辐射癌细胞并促使其凋亡以达到治疗效果。 该产品已获FDA孤儿药认定。目前，TLX101全球研发进展顺利，其中国I期临床已于2023年4月获批;海外方面，该产品有望于2025年上半年向美国FDA提交 新药临床试验(IND)，并在2025年下半年开启临床试验。 本次IPAX-Linz研究是一项研究者发起的II期临床研究，旨在评估TLX101联合外照射放射治疗(EBRT)在首次或第二次复发的高级别胶质瘤(HGG)患者(包括胶 质母细胞瘤)中的安全性、 ...

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical sector [1]. Core Insights - The commercialization of nuclear medicine is accelerating, with significant growth in diagnostic nuclear drugs and the potential for domestic nuclear drugs to reach a commercialization inflection point [3][17]. - The report highlights the successful commercialization of Pluvicto and Lutathera, which are expected to generate substantial revenues, with Pluvicto projected to exceed $5 billion in peak sales [3][12]. - The report emphasizes the similarities between Radioligand Therapy (RDC) and Antibody-Drug Conjugates (ADC), suggesting that RDC could replicate the success of ADC in the market [3][22]. Summary by Sections Part 1: Overseas Nuclear Drug Rapid Growth, Domestic Commercialization Period - Overseas nuclear drugs are experiencing rapid commercialization, with Pluvicto achieving $1.392 billion in revenue in 2024, a 42% increase, and Lutathera generating $724 million, a 20% increase [3][12]. - The combined revenue from these two drugs for Novartis reached $2.116 billion, indicating the ongoing value realization of nuclear drugs [3][12]. - The report notes that the domestic nuclear drug market is set to expand significantly, with five new nuclear drugs approved since 2020, including Yttrium-90 microspheres from Yuan Da Pharmaceutical, which is expected to generate nearly HKD 500 million in revenue in 2024, a growth rate exceeding 140% [3][20]. Part 2: RDC Expected to Replicate ADC Success Path - RDC shares structural and mechanistic similarities with ADC, consisting of a targeting ligand, a linker, and a radioactive nuclide [3][22]. - The report outlines that both RDC and ADC have followed similar validation timelines, with ADC gaining market traction after the success of Enhertu, while RDC is now gaining attention following the success of Pluvicto [3][22]. - The market for new nuclear drugs is projected to reach approximately $4-5 billion in 2024, comparable to the ADC market size around 2021 [3][22]. Part 3: Domestic Nuclear Drug Pipeline Overview - The report details the current pipeline of domestic nuclear drugs, with three products in the NDA stage, including Novartis's PSMA diagnostic and therapeutic drugs [3][49]. - The leading targets in domestic research remain PSMA, FAP, and SSTR, with companies like Yuan Da Pharmaceutical and Xiantong Pharmaceutical leading in clinical project numbers [3][53]. - The anticipated approval of Novartis's two PSMA-targeted products in Q2 2025 is expected to further stimulate the domestic nuclear medicine market [3][20].

Summary of Conference Call Notes Company and Industry Overview - The conference call involved **Yuan Da Pharmaceutical**, discussing its performance and strategies in the **pharmaceutical industry**, particularly focusing on **nuclear medicine** and **innovative drug development** [1][2][29]. Key Points and Arguments Financial Performance - **Total revenue** for the year reached **HKD 11.64 billion**, a **12.8%** increase year-over-year [2]. - The **Hoya segment** showed remarkable growth, achieving **HKD 590 million** in revenue, up **176.6%** year-over-year, indicating strong innovation and market demand [2]. - The company maintained a **dividend payout** of **HKD 910 million**, consistent with the previous year [2]. Product Development and Innovation - A total of **33 products** were launched last year, including **2 innovative products** and **21 major milestones** in clinical trials [3]. - The company has expanded its product lines in various segments, including cardiovascular devices and respiratory products, contributing to sustained revenue growth [3][4]. - The **nuclear medicine** sector is highlighted as a key growth area, with ongoing collaborations with international firms like **Telix** and **IPM** to enhance product offerings [6][38]. Market Strategy and Future Outlook - The company aims to launch **23 innovative products** by **2025**, focusing on high-demand areas such as interventional medicine and respiratory treatments [24][25]. - There is a strong emphasis on expanding the **nuclear medicine** market, with plans to enhance clinical trial submissions to the **FDA** and **CDE** [50][51]. - The company is positioning itself as a leader in the **nuclear medicine** field, with a focus on addressing unmet clinical needs and expanding its global footprint [41][42]. Challenges and Responses - The pharmaceutical industry is undergoing significant reforms, presenting both opportunities and challenges. The company is adapting by enhancing its product pipeline and focusing on innovative solutions [1][5]. - The management expressed confidence in navigating financial pressures and emphasized a proactive approach to product development and market expansion [30][32]. Additional Important Content - The company has established a **global supply network** for nuclear medicine, covering over **50 countries** and regions, which is crucial for its international growth strategy [9]. - There is a notable increase in the **academic promotion team**, with a **90%** growth in team members and an **80%** increase in trained surgeons, which is expected to drive product adoption [10]. - The company is committed to maintaining a strong pipeline of **generic drugs** while transitioning towards more innovative products, reflecting a strategic shift in its business model [29][32]. This summary encapsulates the key insights from the conference call, highlighting the company's financial performance, product innovation, market strategies, and future outlook within the pharmaceutical industry.

证券研究报告 | 2025年04月11日 远大医药（00512.HK） 优于大市 2024 年归母净利同比增长 31%，核药龙头杨帆启航 收入同比增长 10.6%，归母净利润同比增长 31.3%。2024 年公司实现收入 116.45 亿港币，同比增长 10.6%，扣除汇率变动影响同比增长约 12.8%；实 现归母溢利 24.68 亿港币，同比增长 31.3%；若扣除对 Telix 投资的公允价 值变动收益（7.08 亿港币），正常化归母溢利约 17.61 亿港币，同比增长约 2.5%，进一步扣除汇率变动的影响后同比增长约 4.6%，在较大的外部环境压 力下保持业绩的良好增长。 五官科和呼吸类产品表现亮眼，核药抗肿瘤板块持续高速放量。扣除汇率变 动影响，2024 年制药科技板块实现收入 73.18 亿港币，同比增长 9.6%，其 中呼吸及危重症业务收入 17.09 亿港币，同比增长约 26.9%，主要因为核心 产品切诺的临床需求持续增长以及新产品恩卓润、恩明润和布地奈德鼻喷雾 剂的快速放量；五官科业务收入 27.04 亿港币，同比增长 19.3%，主要是新 品销售带来增长；心脑血管急救业务收入 21.76 亿 ...