远大医药(00512)发布公告，集团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。该研究是一项前瞻性、多中心、随 机、平行对照临床研究，旨在评估GPN00289用于原发性肝癌经动脉化疗栓塞的安全性和有效性。此次 GPN00289的注册性临床研究完成全部患者入组是集团在核药抗肿瘤诊疗领域在肿瘤介入方向上的又一 次重大的研发进展。 板块内创新产品全球研发工作顺利推进。中国方面，易甘泰钇[90Y]微球注射液于2022年1月顺利上市， 用于治疗结直肠癌肝转移，并于2025年5月获得中国药监局批准开展治疗不可切除HCC的II期注册性临 床试验;全球创新温度敏感性栓塞剂GPN00289于2024年12月完成了注册性临床研究的首例患者入组。海 外注册方面，SIR-Spheres钇[90Y]微球注射液(易甘泰)于2025年7月在美国提前正式获批新适应证，用于 治疗不可切除HCC，标志着SIR-Spheres钇[90Y]微球注射液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;于2025年9月 ...

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 ...

格隆汇10月9日丨远大医药(00512.HK)公告，集团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。该研究是一项前瞻 性、多中心、随机、平行对照临床研究，旨在评估GPN00289用于原发性肝癌经动脉化疗栓塞的安全性 和有效性。此次GPN00289的注册性临床研究完成全部患者入组是集团在核药抗肿瘤诊疗领域在肿瘤介 入方向上的又一次重大的研发进展。 集团拥有GPN00289的全球权益，该产品已于2024年7月在中国进入注册性临床研究阶段，并于于2024年 12月完成首例患者入组。未来，集团将积极推进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，进一步深化集团核药抗肿瘤诊疗板块的产业布局。 GPN00289是一款获得中国国家药品监督管理局(「药监局」)创新型医疗器械资质认定的温度敏感性栓 塞材料，用于治疗富血管的良性及恶性肿瘤。该产品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 ...

Core Viewpoint - The company reported record-high revenue of HKD 6.11 billion for the first half of 2025, with innovative and barrier products accounting for approximately 51% of total revenue, reflecting a nearly 15 percentage point increase year-on-year [1] Group 1: Financial Performance - The company's net profit for the period was HKD 1.17 billion [1] - Excluding the impact of centralized procurement and exchange rates, the company's revenue grew approximately 13% year-on-year [1] Group 2: Research and Development - The company invested a total of HKD 1.02 billion in research and project development during the period, achieving 38 significant milestone advancements [1] - The company currently has 42 innovative projects in its pipeline [1] Group 3: Product Performance - The nuclear medicine segment achieved a remarkable 106% year-on-year revenue increase, generating HKD 420 million [1] - The core product, Yttrium-90 microsphere injection, continues to demonstrate strong market potential with rapid growth [1] Group 4: Strategic Developments - The company’s global leading nuclear medicine R&D and production base in Chengdu has commenced operations, facilitating a strategic leap from R&D to industrial-scale production [2] - The innovative radioactive nuclide conjugated drug GPN02006 has made breakthrough progress in domestic IIT clinical research and has been approved for oral presentation at the 2025 SNMMI annual meeting [2] Group 5: Commercialization and Market Expansion - The innovative eye drug GPN01768 (TP-03) generated over USD 100 million in overseas revenue during the first half of the year, marking a nearly 152% year-on-year increase [2] - The company is advancing the global clinical development of its self-developed innovative product STC3141, which has received approval for seven clinical batches in five countries [2]

Core Viewpoint - The company reported strong mid-year results for 2025, with significant revenue growth driven by innovative products and strategic advancements in various therapeutic areas [1][2]. Group 1: Financial Performance - The company achieved revenue of approximately HKD 61.1 billion, with innovative and barrier products accounting for about 51% of total revenue, an increase of nearly 15 percentage points year-on-year [1]. - Net profit for the period was approximately HKD 11.7 billion [1]. - Excluding the impact of centralized procurement and exchange rates, revenue grew approximately 13% year-on-year [1]. Group 2: Research and Development - The company invested approximately HKD 10.2 billion in research and development, achieving 38 significant milestone advancements during the period [1]. - A total of 42 innovative projects are currently in the company's pipeline [1]. Group 3: Strategic Developments - The company has established a differentiated innovation pipeline in key strategic areas such as nuclear medicine for cancer treatment, respiratory and critical care, innovative ophthalmic drugs, and cardiovascular emergency care [1]. - The nuclear medicine segment reported a remarkable revenue growth of nearly 106% year-on-year, generating HKD 4.2 billion in revenue [1][2]. - The company’s global leading nuclear medicine R&D and production base in Chengdu has commenced operations, facilitating a strategic leap from R&D to industrial-scale production [2]. Group 4: Product Innovations - The company’s innovative product STC3141 for treating sepsis has successfully reached the endpoint of Phase II clinical trials in China, representing a potential breakthrough in sepsis treatment [2]. - Other innovative products, including nasal spray treatments for dry eye disease and various respiratory medications, are also advancing towards commercialization, contributing to steady growth in the pharmaceutical technology sector [2].

Group 1 - The company reported a record revenue of approximately HKD 6,107,320,000 for the six months ending June 30, 2025, representing a year-on-year increase of about 1.0% [1] - Revenue in RMB terms increased by approximately 2.0% year-on-year, and if excluding the impact of the tenth batch of centralized procurement price reductions, the revenue in RMB terms increased by approximately 13.0% [1] - Revenue from innovative and barrier products accounted for about 51.0% of total revenue, an increase of 14.9 percentage points compared to the same period last year [1] Group 2 - The profit attributable to the company's owners for the period was approximately HKD 1,169,020,000, a decrease of about 25.0% compared to the same period in 2024 [2] - Excluding the impact of RMB and HKD exchange rate fluctuations, the profit decreased by approximately 24.2% compared to 2024 [2] - The fair value change and disposal gains from the investment in Telix amounted to approximately HKD 151,730,000, a decrease of HKD 324,910,000 compared to the same period last year [2] Group 3 - The company continued to invest resources in the advancement of research projects and the introduction of innovative projects, with total investment in R&D and related expenditures amounting to approximately HKD 1,022,000,000 [2]

Core Viewpoint - The article highlights the significant milestone achieved by the leading nuclear medicine company, YuanDa Pharmaceutical, in expanding its innovative nuclear drug SIR-Spheres® Yttrium-90 microsphere injection (Yigan Tai®) for the treatment of unresectable hepatocellular carcinoma (HCC), marking a breakthrough in the global nuclear medicine market targeting a potential market size of 10 billion yuan [2][3]. Summary by Sections Product Approval and Clinical Significance - YuanDa Pharmaceutical's SIR-Spheres® Yttrium-90 microsphere injection has received FDA approval for a new indication to treat unresectable HCC, making it the first and only selective internal radiation therapy product approved for both unresectable HCC and colorectal cancer liver metastases [2][4]. - The product utilizes advanced interventional techniques to deliver high-energy beta radiation directly to tumor cells, showcasing its dual advantages as both a radiopharmaceutical and a precise interventional treatment [4]. Market Potential and Growth - The global liver cancer treatment market is projected to reach approximately $9.81 billion by 2030, indicating a substantial opportunity for innovative treatments like Yigan Tai® to address the high unmet medical need in liver cancer therapy [7]. - Since its approval in China, Yigan Tai® has rapidly gained traction, treating nearly 2,000 patients by the end of 2024, with sales revenue expected to reach nearly 500 million HKD, reflecting a year-on-year growth rate exceeding 140% [5]. Industry Position and Future Outlook - YuanDa Pharmaceutical has established a comprehensive nuclear medicine ecosystem through extensive international development and research investments, positioning itself as a leader in the nuclear medicine sector with a robust pipeline of 15 innovative products targeting various cancers [9][10]. - The company aims to enhance its nuclear medicine offerings by integrating diagnostic and therapeutic solutions, thereby solidifying its leadership position in the global nuclear oncology market [10].

Investment Rating - The report gives a "Buy" rating for the company, marking its first coverage [1][10]. Core Insights - The company is expected to experience significant growth in its nuclear medicine sector, with the STC3141 sepsis product projected to become a major global drug. The report emphasizes the potential of new products in various therapeutic areas, including respiratory, critical care, and ophthalmology [3][9]. - The company has a diversified product portfolio and a robust pipeline, with a focus on innovative therapies and strategic acquisitions to enhance its market position [9][18]. Summary by Sections 1. Company Overview - The company operates in three main segments: nuclear medicine, pharmaceutical technology, and biotechnology, with a strong emphasis on innovation and market expansion through acquisitions [9][18]. 2. Nuclear Medicine Sector - The nuclear medicine segment is rapidly growing, with a focus on the core product Yttrium-90 (Y[90]) and a pipeline of 12 innovative products targeting various cancers. The company has established partnerships with leading international firms to enhance its research and development capabilities [9][35][37]. 3. Pharmaceutical Technology - The pharmaceutical technology segment is expected to see growth from new products in the respiratory and critical care fields, as well as in ophthalmology. The company is well-positioned to capitalize on the market opportunities presented by these new therapies [3][9]. 4. Financial Projections - The company forecasts revenue growth from 116.45 billion HKD in 2024 to 146.63 billion HKD by 2027, with net profit expected to rise from 24.68 billion HKD to 27.64 billion HKD in the same period. The projected P/E ratios indicate that the company is undervalued compared to its peers [1][10][24]. 5. Market Potential - The global nuclear medicine market is projected to grow significantly, with estimates suggesting a rise from 10.7 billion USD in 2023 to 22.8 billion USD by 2030. The Chinese market for radiopharmaceuticals is also expected to expand rapidly, driven by increasing demand and regulatory support [36][38].

Core Viewpoint - The stock price of Yuan Da Pharmaceutical has surged nearly 50% in May, reaching a historical high of 9.20 HKD, driven by positive news regarding its innovative ophthalmic drug GPN01768, which has been approved for market in Macau [1][3]. Group 1: Product Development and Market Potential - GPN01768 is the first and only FDA-approved drug for treating Demodex blepharitis, with exclusive rights for development, production, and commercialization in Greater China [3]. - The approval of GPN01768 in Macau is expected to facilitate its future launch in the Guangdong-Hong Kong-Macau Greater Bay Area and further promote its entry into mainland China [3]. - The global prevalence of Demodex blepharitis is significant, with an estimated 468 million patients in 2021, projected to increase to approximately 506 million by 2030 [4][6]. - GPN01768 has shown strong market penetration in the U.S., generating $180 million in revenue in 2024 and achieving $78.3 million in sales in Q1 2025, reflecting an 18% increase from the previous quarter [6][7]. Group 2: Clinical Need and Competitive Advantage - There is currently no specific treatment for Demodex blepharitis, highlighting the urgent need for effective therapies, which GPN01768 aims to address [6]. - GPN01768 acts as a selective non-competitive antagonist of the GABA-Cl channel in Demodex mites, leading to their paralysis and death, thus providing a targeted treatment option [6]. - The domestic market for blepharitis treatment is estimated to be around 1.85 billion RMB in 2023, indicating substantial commercial potential for GPN01768 in China [7]. Group 3: Innovation and Strategic Positioning - Yuan Da Pharmaceutical has established a comprehensive innovation framework across multiple business segments, particularly in ophthalmology, positioning itself as a "hidden leader" in the domestic market [8]. - The company has a robust pipeline of innovative products targeting various eye conditions, with several expected to receive approval in the next three years [8]. - The company’s nuclear medicine division has also made significant advancements, with a new facility set to enhance its production capabilities and meet growing market demands [14][15]. Group 4: Market Sentiment and Future Outlook - The capital market has recognized the company's innovative transformation, with multiple research institutions raising the stock price expectations, including a target price increase to 9.6 HKD by CICC and 10.15 HKD by Huatai Securities [14]. - The ongoing development of innovative products across various segments is anticipated to drive sustained growth and performance for the company [15].

Group 1 - The company is advancing its innovative radiopharmaceuticals, including GPN02006 for diagnosing hepatocellular carcinoma (HCC), with results from clinical research expected to be presented at the 2025 SNMMI annual meeting [1] - GPN02006 is a targeted diagnostic radiopharmaceutical based on radiolabeled antibody technology, aiming to provide a new and more precise molecular imaging solution for HCC diagnosis [1] - The company has also made progress with TLX591 and TLX591-CDx, with TLX591 being a therapeutic radiopharmaceutical that has received acceptance for international multi-center Phase III clinical application [2] Group 2 - The company's nuclear medicine segment has entered a growth phase, achieving revenue of HKD 589 million in 2024, a significant increase of 177% year-on-year [3] - The core product, Yttrium-90 microsphere injection, has become a key driver of revenue growth, contributing HKD 500 million, with a year-on-year increase of over 140% [3] - The company has established a comprehensive industrial layout covering research, production, sales, and regulatory qualifications, with a global R&D and production base for radiopharmaceuticals in Chengdu [3]