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 ...

集团联合Sirtex Medical Pty Ltd并与Telix Pharmaceutical Limited (ASX: TLX; NASDAQ: TLX)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RDC药物研发 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Ga、Lu、I、 Y、Zr在内的 5种放射性核素，覆盖了肝癌、前列腺癌、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。 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[Y]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[Y]微球注射液(易甘泰)于 ...

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 全球創新溫度敏感性栓塞劑在中國的註冊性臨床研究 完成全部患者入組 -1- 不良反應，安全性高，且可即時顯影，滿足手術精准操作需求。 根據 GLOBOCAN 2022 年的數據，肝癌全球新發病例約 87 萬，位居腫瘤第六位；死亡 病例約 76 萬，居第三位。中國國家癌症中心 2024 年全國癌症報告顯示，2022 年中國 新發肝癌約 37 萬例（占全球 42.5%），居腫瘤第四位；死亡病例約 32 萬例（占全球 42.1%)，居第二位；佔比均居全球首位。手術切除是治療早期肝癌的首選方法，但由 於肝癌發病隱匿，早期症狀不明顯或不典型，早診困難，不足 30%的肝癌患者在初診 時適合根治性治療，治療棘手，因此預後較差，發病率與死亡率之比高達 1： ...

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 recent announcement of the "Early Screening and Diagnosis Project for Urothelial Carcinoma" by the company at a major academic conference has positively impacted its stock performance, reflecting strong market interest in its innovative capabilities and growth strategy [1][2]. Group 1: Company Performance - The company's stock price increased by 4.45%, reaching HKD 9.38, with a trading volume of HKD 72.96 million [1]. - For the first half of 2025, the company reported a revenue of HKD 6.107 billion, representing a year-on-year growth of 1.0%, and a 2.0% increase when excluding foreign exchange effects [2]. - The net profit attributable to the parent company was HKD 1.169 billion, exceeding market expectations primarily due to higher-than-expected revenue [2]. Group 2: Product Development and Innovation - The company's nuclear medicine oncology segment generated revenue of HKD 422 million, showing a significant year-on-year increase of 105.5% when excluding foreign exchange effects, driven by the rapid market uptake of Yigantai [2]. - Yigantai received FDA approval for use in primary liver cancer, marking it as the first product globally approved for both primary liver cancer and colorectal cancer liver metastases in internal radiation therapy [2]. - The company is advancing its clinical pipeline, with TLX-591CDx completing Phase III clinical enrollment and other products like TLX591 and ITM-11 entering international multi-center Phase III trials [2].

Core Viewpoint - The recent announcement of the "Urothelial Carcinoma Early Screening and Diagnosis Project" by the company at a major academic conference has positively impacted its stock price, reflecting strong market interest in its innovative capabilities and strategic direction [1]. Group 1: Financial Performance - For the first half of 2025, the company's revenue reached HKD 6.107 billion, representing a year-on-year increase of 1.0%, and a 2.0% increase when excluding foreign exchange effects [2]. - The net profit attributable to the parent company was HKD 1.169 billion, exceeding expectations primarily due to higher-than-expected revenue [2]. - The company's nuclear medicine oncology segment generated revenue of HKD 422 million, showing a significant year-on-year increase of 105.5% when excluding foreign exchange effects, driven by the rapid market uptake of Yigantai [2]. Group 2: Product Development and Innovation - Yigantai received FDA approval for use in primary liver cancer, marking it as the first product globally approved for both primary liver cancer and colorectal cancer liver metastases in internal radiation therapy [2]. - The company is making steady progress in its clinical trials, with TLX-591CDx completing Phase III clinical enrollment, and products like TLX591 and ITM-11 entering international multi-center Phase III clinical trials [2]. - The self-developed innovative nuclear medicine product GPN02006 was showcased at an international conference, highlighting the company's commitment to research and development in this field [2].

Core Viewpoint - The report from CICC indicates that the performance of Wande Pharmaceutical (00512) in 1H25 demonstrates strong anti-risk capabilities, leading to an upward revision of the net profit forecast for 2025 and 2026 by 3.3% and 3.4% to HKD 1.91 billion and HKD 2.10 billion respectively. The current stock price corresponds to a P/E ratio of 18.0x for 2025 and 16.4x for 2026. Given the continuous realization of the company's innovative pipeline, the firm maintains an outperform rating and raises the target price by 21.9% to HKD 11.7, implying a potential upside of 20.6% from the current stock price [1]. Group 1 - The 1H25 performance exceeded expectations, with revenue reaching HKD 6.107 billion, a year-on-year increase of 1.0%, and a net profit of HKD 1.169 billion, surpassing forecasts primarily due to higher-than-expected revenue [2]. - The company demonstrated solid operational performance supported by the growth of innovative and barrier products, which accounted for approximately 51% of total revenue in 1H25, up from 36.1% in the same period last year. Excluding the impact of the tenth batch of centralized procurement, revenue in RMB terms grew by about 13.0% year-on-year, indicating sustainable growth [3]. Group 2 - The nuclear medicine segment continued its doubling growth trend, with revenue of HKD 422 million in 1H25, reflecting a year-on-year increase of 105.5% after excluding currency effects, primarily driven by the rapid growth of Yigan Tai. Additionally, Yigan Tai received FDA approval for use in primary liver cancer, becoming the first product approved for this indication globally [4]. - The company is making significant progress in its innovative radiolabeled drug conjugate (RDC) pipeline, with TLX-591CDx completing Phase III clinical enrollment and other products entering international multi-center Phase III trials, while the self-developed innovative nuclear drug GPN02006 was showcased at an international conference [4]. Group 3 - The company is advancing the development of STC3141, a potential first-in-class treatment for sepsis, which has completed Phase II clinical trials in both overseas and China, laying the groundwork for global pivotal registration studies. The company is actively exploring various efficient global collaboration models to accelerate the product's market entry [5].

Core Viewpoint - CICC has raised the profit forecast for Far East Pharmaceutical (00512) for 2025 and 2026 by 3.3% and 3.4% to HKD 1.91 billion and HKD 2.10 billion respectively, citing strong performance in 1H25 and good risk resilience [1][2] Group 1: Financial Performance - The company reported 1H25 revenue of HKD 6.107 billion, a year-on-year increase of 1.0%, and a 2.0% increase when excluding exchange rate effects [2] - The net profit attributable to shareholders for 1H25 was HKD 1.169 billion, exceeding expectations primarily due to higher-than-expected revenue [2] - The revenue from innovative and barrier products accounted for approximately 51% of total revenue, up from 36.1% in the same period last year [2] Group 2: Product Development - The nuclear medicine segment continued to show strong growth, with revenue of HKD 422 million in 1H25, reflecting a 105.5% year-on-year increase when excluding exchange rate effects [3] - The product 易甘泰 received FDA approval for use in primary liver cancer, marking it as the first approved treatment for both primary liver cancer and colorectal cancer liver metastases [3] - The company is advancing its innovative radiopharmaceutical drug conjugate (RDC) pipeline, with TLX-591CDx completing Phase III clinical trial enrollment [3] Group 3: R&D Focus - The company is making progress in the development of STC3141 for sepsis, having completed Phase II clinical trials in both overseas and China [4] - There is potential for STC3141 to become a first-in-class treatment, and the company is exploring various global collaboration opportunities to expedite the product's market entry [4]

Core Viewpoint - The company reported a slight increase in revenue but a significant decline in profit, indicating challenges in maintaining profitability amid rising costs and increased spending on new product launches [1][2]. Group 1: Financial Performance - The company achieved a revenue of 6.107 billion HKD for the first half of 2025, representing a year-on-year increase of 0.99% [1]. - Shareholder profit was reported at 1.169 billion HKD, down 24.96% year-on-year, while normalized profit (excluding the impact of Telix investment) was 1.017 billion HKD, a decrease of 5.92% [1]. - Gross margin for the first half of 2025 was 58.95%, a decline of 0.44 percentage points year-on-year [1]. - The net profit margin for the first half of 2025 was 19.22%, down 7.03 percentage points year-on-year [1]. Group 2: Business Segments - The nuclear medicine and cardiovascular intervention segment generated revenue of 5.78 billion HKD, with nuclear medicine alone contributing 4.22 billion HKD, reflecting a year-on-year increase of 105.5% [2]. - The pharmaceutical technology segment reported revenue of 38.45 billion HKD, with respiratory and critical care products generating 10.47 billion HKD, up 9.9% year-on-year [2]. - The biotechnology segment's revenue was 16.84 billion HKD, down 11.9% year-on-year, with amino acid products contributing 13.47 billion HKD, a decrease of 9.5% [2]. Group 3: Pipeline and Innovation - The nuclear medicine pipeline is advancing, with the Yttrium-90 microsphere receiving FDA approval for inoperable HCC indications, and domestic Phase II clinical trials approved [2]. - The company is making significant progress in various clinical trials, including the completion of Phase III enrollment for TLX591-CDx for prostate cancer and the initiation of international multi-center Phase III trials for other treatments [2]. - The respiratory department completed Phase II clinical trials for STC3141 targeting sepsis and plans to apply for breakthrough therapy designation [2]. Group 4: Future Outlook - The company expects revenues of 12.291 billion HKD, 13.762 billion HKD, and 15.262 billion HKD for 2025, 2026, and 2027 respectively, with shareholder profits projected at 2.039 billion HKD, 2.466 billion HKD, and 2.863 billion HKD for the same years [3]. - The company is rated as a "buy" based on its diverse core business across nuclear medicine, cardiovascular intervention, pharmaceutical technology, and biotechnology [3].