Core Viewpoint - Far East Pharmaceutical announced the completion of patient enrollment for its innovative temperature-sensitive embolic agent GPN00289 in a clinical study for primary liver cancer in China, highlighting its potential to address the limitations of current treatment methods [1][2] Group 1: Product Development - GPN00289 is recognized as an innovative medical device by the National Medical Products Administration of China [1] - The product combines the advantages of liquid and solid embolization, allowing for effective drug delivery and embolization [1] - The product is expected to be used in conjunction with existing chemotherapy drugs and the company's internal radiotherapy drug, Yttrium-90 microspheres [1] Group 2: Market Strategy - The company aims to actively promote the global registration and development of GPN00289 [2] - There is a strategic focus on creating synergies between GPN00289 and Yttrium-90 microspheres to enhance the treatment of liver cancer [2] - The company is committed to deepening its technological innovation in the global liver cancer treatment field and expanding its nuclear medicine oncology diagnosis and treatment sector [2]

Core Viewpoint - The announcement highlights the completion of patient enrollment for the clinical study of GPN00289, a temperature-sensitive embolic agent for primary liver cancer, marking a significant R&D advancement for the company in the field of tumor intervention [2][3]. Product Development - GPN00289 has received innovative medical device certification from the National Medical Products Administration in China, indicating its potential in enhancing treatment options for liver cancer [2]. - The product combines the advantages of liquid and solid embolization, addressing the limitations of current transcatheter arterial chemoembolization (TACE) methods [2][3]. Clinical Features - GPN00289 features temperature responsiveness and high plasticity, allowing it to undergo phase transitions with temperature changes, enabling effective embolization of various blood vessel sizes and shapes [3]. - The product is biodegradable, providing opportunities for multiple treatments, and has drug-loading capabilities, which may allow for combination therapy with existing chemotherapy drugs and the company's radioactive treatment product, Yttrium-90 microspheres [3]. Strategic Positioning - The company holds global rights to GPN00289 and plans to actively pursue its global registration and development, aiming for strategic synergy with Yttrium-90 microspheres in both domestic and international markets [3]. - The company has established a leading position in the embolic agent sector, with a comprehensive product matrix, which could enhance its core competitiveness in liver cancer treatment if GPN00289 is successfully approved for market [3]. Industry Focus - Tumor intervention is a key strategic direction for the company, which has invested years in the nuclear medicine and anti-tumor diagnosis and treatment sector, achieving a comprehensive layout across R&D, production, distribution, and sales [4]. - The company has established a global nuclear medicine industry chain, with R&D bases in Boston and Chengdu, and production facilities in multiple international locations, supported by a sales network covering over 50 countries and regions [4].

Core Viewpoint - The company, Far East Pharmaceutical, has completed patient enrollment for its innovative temperature-sensitive embolic agent GPN00289 in a clinical study for primary liver cancer in China, aiming to assess its safety and efficacy [1] Group 1 - The clinical study is a registration trial for GPN00289, specifically targeting transarterial chemoembolization for primary liver cancer [1] - The completion of patient enrollment marks a significant milestone in the development of GPN00289 [1]

Core Viewpoint - The completion of patient enrollment for the clinical study of GPN00289, a temperature-sensitive embolic agent for primary liver cancer, marks a significant advancement in the company's research and development in the field of nuclear medicine for tumor treatment [1][4]. Group 1: Product Overview - GPN00289 is an innovative temperature-sensitive embolic material recognized by the National Medical Products Administration of China, designed for treating hypervascular benign and malignant tumors [2]. - The product exhibits temperature-responsive properties, allowing it to transition from liquid to solid state, effectively embolizing various blood vessels [2]. - GPN00289 combines the advantages of liquid and solid embolization, addressing the limitations of current transcatheter arterial chemoembolization (TACE) methods [3]. Group 2: Market Context - According to GLOBOCAN 2022, there are approximately 870,000 new liver cancer cases globally, with around 760,000 deaths, highlighting the critical need for effective treatment options [3]. - In China, liver cancer accounts for about 37% of global new cases and 32% of deaths, indicating a significant market opportunity for innovative treatments [3]. Group 3: Strategic Development - The company holds global rights to GPN00289 and aims to advance its global registration and development, particularly in collaboration with the innovative internal radiotherapy drug, Yttrium-90 microspheres [4]. - The company has established a comprehensive nuclear medicine industry chain, including research, production, distribution, and sales, with over 900 employees globally [4][8]. Group 4: Collaborative Efforts - The company collaborates with Sirtex Medical Pty Ltd and Telix Pharmaceutical Limited to develop an international standard tumor intervention research and development platform [5]. - The company has a pipeline of 15 innovative products in the registration phase, covering various radioactive isotopes and multiple cancer types [5]. Group 5: Infrastructure and Innovation - The company’s new radioactive drug research and production base in Chengdu, China, is the first of its kind globally, covering the entire nuclear medicine industry chain [8]. - The base aims to enhance the company's research and production capabilities, ensuring high-quality development in the nuclear medicine sector [8][9].

Core Viewpoint - YuanDa Pharmaceutical has made significant progress in the field of liver cancer treatment with its innovative temperature-sensitive embolization agent GPN00289, which has completed patient enrollment for a pivotal clinical study in China [1][4]. Group 1: Product Development and Clinical Progress - GPN00289 has received innovative medical device certification from the National Medical Products Administration in China, marking a major R&D advancement for the company in the tumor intervention sector [1]. - The product combines the advantages of liquid and solid embolization, addressing the limitations of current transcatheter arterial chemoembolization (TACE) methods, and is expected to be a superior option for liver cancer treatment [4][5]. - GPN00289 features temperature responsiveness and high plasticity, allowing it to effectively occlude various blood vessels and prevent collateral circulation, thus enhancing treatment efficacy [5]. Group 2: Market Potential and Competitive Landscape - According to statistics, the global embolization therapy market is projected to grow from approximately $4.097 billion in 2023 to about $6.536 billion by 2030, with a compound annual growth rate of around 7.0% [6]. - Despite the large market potential, the embolization agent sector remains underdeveloped, presenting a blue ocean market opportunity for YuanDa Pharmaceutical, which has established a leading position through strategic product development [6]. Group 3: Strategic Initiatives and Global Expansion - The company is committed to advancing GPN00289's global registration and development, aiming to create synergistic effects with its other innovative products, particularly the Yttrium-90 microsphere injection [5][10]. - YuanDa Pharmaceutical has built a comprehensive global nuclear medicine industry chain, with R&D and production bases in Boston, Frankfurt, Singapore, and Chengdu, and a sales network covering over 50 countries [7]. - The company has a robust pipeline of 15 innovative products in the nuclear medicine sector, targeting multiple cancer types, which positions it as a leader in integrated cancer treatment solutions [7][10].

Core Viewpoint - The company has completed patient enrollment for the registration clinical study of its innovative temperature-sensitive embolic agent GPN00289 in China, marking a significant advancement in its research and development in the field of nuclear medicine for cancer treatment [1][3]. Group 1: Product Overview - GPN00289 is an innovative medical device recognized by the National Medical Products Administration of China, designed for treating hypervascular benign and malignant tumors. It features temperature-responsive properties that allow it to transition from liquid to solid state, enabling effective embolization of various blood vessels [2]. - The product exhibits good flowability at room temperature and can be delivered to the target blood vessels via microcatheters. Upon reaching body temperature, it solidifies in situ, achieving complete embolization of the target tissue's peripheral blood vessels, effectively preventing collateral circulation and ensuring long-lasting arterial blood flow blockage [2]. Group 2: Clinical Development and Strategic Plans - The global rights for GPN00289 are held by the company, which has entered the registration clinical study phase in China as of July 2024, with the first patient enrollment expected to be completed by December 2024. The company aims to actively promote the global registration and development of GPN00289 [3]. - The company plans to synergize GPN00289 with its existing product, Yttrium-90 microsphere injection, to enhance the treatment of liver cancer and deepen its industrial layout in the nuclear medicine oncology sector [3].

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： ...

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。 全球創新溫度敏感性栓塞劑在中國的註冊性臨床研究 完成首例患者入組 本公告乃遠大醫藥集團有限公司（「本公司」，連同其附屬公司統稱「本集團」）之董事 會（「董事會」）自願刊發。 董事會欣然公告，本集團全球創新溫度敏感性栓塞劑產品 GPN00289 在中國開展的用 於原發性肝癌經動脈化療栓塞的註冊性臨床研究，於近日完成了首例患者入組。該研 究是一項前瞻性、多中心、隨機、平行對照臨床研究，旨在評估 GPN00289 用於原發 性肝癌經動脈化療栓塞的安全性和有效性。此次 GPN00289 的註冊性臨床研究完成首 例患者入組是本集團在核藥抗腫瘤診療領域在腫瘤介入方向上的又一次重大的研發進 展。 GPN00289 是一款獲得中國國家藥品監督管理局（「藥監局」）創新型醫療器械資質認 定的溫度敏感性栓塞材料，用於治療富血管的良性及惡性腫瘤。該產品具有溫度響應 且可塑高的特點，可隨溫度的變化發生液固相轉變，對大小不同、形狀各 ...