易甘泰钇[90Y]微球注射液

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远大医药:创新温度敏感性栓塞剂在中国的注册性临床研究完成全部患者入组
Zhong Zheng Wang· 2025-10-09 13:28
中证报中证网讯(王珞)远大医药10月9日晚公告称,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,于近日完成了全部患者入组。GPN00289 是一款获得国家药监局创新型医疗器械资质认定的温度敏感性栓塞材料。 手术切除是治疗早期肝癌的首选方法,但由于肝癌发病隐匿,早期症状不明显或不典型,早诊困难,不 足30%的肝癌患者在初诊时适合根治性治疗,治疗棘手,因此预后较差。 GPN00289结合了液体栓塞和固体栓塞的优势,集载药和栓塞为一体,可弥补现有TACE治疗手段的缺 陷同时,基于GPN00289的载药特性,该产品除了可以与现有化疗药物进行联用外,还有望与公司的内 放射性治疗药物易甘泰钇[90Y]微球注射液进行联用。 远大医药表示,未来将积极推进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, 进一步深化公司核药抗肿瘤诊疗板块的产业布局。 公告显示,临床上针对中晚期肝癌患者最经典的治疗手段是经导管动脉化疗栓塞术(TACE),常规TACE 主要 ...
远大医药:全球创新温度敏感性栓塞剂在中国的注册性临床研究完成全部患者入组
Zhi Tong Cai Jing· 2025-10-09 10:45
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 ...
远大医药亮相BIOHK2025 Go Global战略打开全球创新药市场
Zhi Tong Cai Jing· 2025-09-11 13:09
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].
远大医药绩后涨超4% 上半年收入创历史新高 易甘泰有望引领公司业绩高增
Zhi Tong Cai Jing· 2025-08-20 06:57
Core Viewpoint - The company, Yuan Da Pharmaceutical, has demonstrated robust growth in its mid-year performance, achieving a record revenue of approximately 6.11 billion HKD, with significant contributions from innovative and barrier products [1] Financial Performance - The company reported a revenue of approximately 6.11 billion HKD for the first half of the year, marking a historical high [1] - Revenue from innovative and barrier products accounted for about 51% of total revenue, an increase of nearly 15 percentage points year-on-year [1] - Excluding the impact of centralized procurement and exchange rates, the company's revenue grew approximately 13% year-on-year [1] - The net profit for the period was recorded at approximately 1.17 billion HKD [1] Product Development - On July 7, the Yttrium-90 microsphere injection received early formal approval from the FDA for a new indication for unresectable hepatocellular carcinoma (HCC), with no restrictions on tumor diameter [1] - The product, Yigan Tai, is the first and only selective internal radiation therapy product approved by the FDA for both unresectable HCC and colorectal cancer liver metastases [1] - Since its approval in China, the Yttrium-90 microsphere injection has rapidly gained traction, treating nearly 2,000 patients by the end of 2024, with projected sales revenue of nearly 500 million HKD for 2024, reflecting a year-on-year growth rate exceeding 140% [1]
港股异动 | 远大医药(00512)绩后涨超4% 上半年收入创历史新高 易甘泰有望引领公司业绩高增
智通财经网· 2025-08-20 06:54
值得注意的是,7月7日,钇[90Y]微球注射液获美国FDA提前正式批准新适应症用于不可切除肝细胞癌 (HCC),且未限制肿瘤直径大小,由此易甘泰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。据悉,易甘泰钇[90Y]微球注射液自中国获批上 市后快速放量,截至2024年末,已累计治疗近2,000例患者,2024年该产品实现近5亿港币销售收入,同 比增速超140%。 智通财经APP获悉,远大医药(00512)绩后涨超4%,截至发稿,涨4.26%,报9.3港元,成交额3.39亿港 元。 消息面上,8月19日,远大医药发布中期业绩,上半年公司再度延续稳健发展态势,取得约61.1亿港元 收入的历史新高,其中创新和壁垒产品收入占比约51%,同比提升近15个百分点,若剔除集采及汇率影 响,公司收入同比增长约13%;期内公司净利润录得约11.7亿港元。 ...
远大医药:上半年实现营收61.1亿港元 核药板块收入同比增长106%
Zhong Zheng Wang· 2025-08-20 01:40
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]
远大医药上半年营收再创新高,创新驱动构筑多元业务板块护城河,Go Global战略铺就长期增长路径
Zhi Tong Cai Jing· 2025-08-19 12:28
Core Viewpoint - The company, Yuan Da Pharmaceutical, reported a strong performance in its 2025 interim financial results, achieving a record revenue of approximately HKD 61.1 billion, with innovative and barrier products contributing about 51% of the revenue, reflecting a year-on-year increase of nearly 15 percentage points [1][2]. Financial Performance - The company recorded a net profit of approximately HKD 11.7 billion for the first half of 2025 [1]. - Excluding the impact of centralized procurement and exchange rates, the company's revenue grew by approximately 13% year-on-year [1]. Product Development and Innovation - The company achieved 38 significant milestones in the first half of the year, including 16 innovative products, and successfully launched the world's first closed-loop nuclear medicine R&D and production base [1][17]. - The STC3141 product, aimed at treating sepsis, reached the endpoint of its domestic Phase II clinical study, showcasing the company's strong R&D capabilities [3]. Market Potential - The global sepsis treatment market is projected to reach USD 12.54 billion by 2032, with a compound annual growth rate (CAGR) of 5.58% [3]. - The company is well-positioned to capture a significant share of the eye care market, which is expected to reach RMB 116.6 billion by 2030 [5][7]. International Expansion - The company is accelerating its "Go Global" strategy, establishing a solid foundation for creating a global pharmaceutical brand [2][15]. - The nuclear medicine sector has become a key area for the company's growth, with revenues in this segment reaching approximately HKD 4.2 billion, reflecting a year-on-year increase of 106% [8][11]. Competitive Advantage - The company has developed a comprehensive product pipeline in nuclear medicine, with 15 innovative products in the R&D registration phase, positioning it as a leader in the field [8][14]. - The successful commercialization of products like the OC-01 nasal spray and GPN01768 has demonstrated the company's ability to penetrate international markets effectively [7][11]. Future Outlook - The company is expected to leverage its strong R&D capabilities and established international presence to enhance its market share in the global nuclear medicine market, projected to reach nearly USD 39 billion by 2032 [15][18]. - With a focus on innovation and global expansion, the company is poised for significant growth, driven by both domestic and international markets [17][18].
远大医药发布中期业绩 收益取得历史新高 达61.07亿港元
Zhi Tong Cai Jing· 2025-08-19 12:22
Core Viewpoint - The company reported a revenue of HKD 6.107 billion for the first half of 2025, reflecting a year-on-year increase of 0.99%, despite facing significant challenges due to price reductions from centralized procurement [1] Group 1: Financial Performance - Gross profit reached HKD 3.6 billion, up 0.25% year-on-year [1] - Shareholders' profit amounted to HKD 1.169 billion, with basic earnings per share at HKD 0.3338 [1] - The company achieved a compound annual growth rate (CAGR) of 12.1% in revenue over the past five years [1] Group 2: Product and Market Performance - The company’s innovative and barrier products accounted for approximately 51.0% of total revenue, an increase of 14.9 percentage points year-on-year [1] - The nuclear medicine oncology segment saw significant growth, with products like Yttrium-90 microsphere injection and LavaTM liquid embolic agent driving revenue to double [2] - The cardiovascular emergency segment benefited from successful commercialization of products like Coenzyme Q10 tablets, contributing to substantial growth from the acquisition of Tianjin Tianbian Pharmaceutical [2] Group 3: Innovation and R&D - The company maintains high R&D investment, establishing eight major research platforms across three global regions, focusing on cutting-edge technologies such as nuclear medicine and mRNA [3] - The innovation pipeline spans the entire R&D process from early development to clinical trials and regulatory submissions, with projects expanding from China to major global markets [3]
远大医药公布2025中期业绩:61.1亿港元收入再创新高,多款创新产品放量尽显发展韧性
Zhi Tong Cai Jing· 2025-08-19 12:16
Core Viewpoint - The company reported record revenue of approximately HKD 6.11 billion for the first half of 2025, with innovative and barrier products accounting for about 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 approximately HKD 1.17 billion [1] - Excluding the impact of centralized procurement and exchange rates, the company's revenue grew by about 13% year-on-year [1] Group 2: Research and Development - The company invested approximately HKD 1.02 billion in research and development during the period, achieving 38 significant milestone advancements [1] - The company currently has 42 innovative projects in its pipeline [1] Group 3: Strategic Focus Areas - 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 achieved a remarkable revenue growth of nearly 106% year-on-year, generating HKD 420 million [1][2] Group 4: Product Development and Market Expansion - The company’s product, Yttrium-90 microsphere injection, continues to demonstrate strong market potential with rapid growth [1] - The FDA granted early approval for the product Yigan Tai for the treatment of unresectable hepatocellular carcinoma (HCC), marking it as the first and only selective internal radiation therapy product approved for both HCC and colorectal cancer liver metastases [2] - The company’s innovative radiopharmaceutical GPN02006 for diagnosing HCC has shown breakthrough results in clinical research, enhancing its global development prospects [2] Group 5: Other Core Strategic Areas - The company’s innovative product STC3141 for treating sepsis has successfully reached the endpoint of its Phase II clinical trial in China [3] - The company is advancing its global clinical development for STC3141, having received approvals for clinical trials in five countries across three continents [3] - In the respiratory and critical care sectors, the company is launching several innovative products that are expected to enhance revenue growth [4]
远大医药尾盘涨超7% 今日盘后将发中期业绩 机构看好公司进入加速发展阶段
Zhi Tong Cai Jing· 2025-08-19 08:03
Core Viewpoint - The stock price of Yuan Da Pharmaceutical (00512) surged over 7% ahead of its earnings announcement, reflecting positive market sentiment driven by recent FDA approval of its radioactive product for treating unresectable hepatocellular carcinoma (HCC) [1] Company Developments - Yuan Da Pharmaceutical plans to hold a board meeting on August 19 to approve its interim results [1] - The company announced that its yttrium-90 microsphere injection has received FDA approval for a new indication, making it the first and only selective internal radiation therapy product approved for both unresectable HCC and colorectal cancer liver metastases [1] - The company has established a complete industrial chain in the nuclear medicine sector, with its core product, Yttrium-90 microsphere injection, rapidly gaining market traction since its domestic approval in 2022 [1] Market Performance - As of the report, Yuan Da Pharmaceutical's stock rose by 6.92%, trading at HKD 8.96, with a transaction volume of HKD 283 million [1] - Tianfeng Securities projected that by the end of 2024, the product will have treated nearly 2,000 patients and is expected to generate nearly 500 million yuan in sales revenue [1] Strategic Focus - The company aims to build a comprehensive layout in tumor interventional therapy and the RDC platform, actively advancing multiple nuclear medicine products in clinical research [1] - The outlook for the company is positive as it enters an accelerated development phase [1]