自願性公告 本集團自主研發的重磅全球創新放射性核素偶聯藥物 GPN01530 在美國獲批開展臨床研究 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，本集團自主研發的全球創新放射性核素偶聯藥物(「RDC」) GPN01530 近日獲得美國食品藥品監督管理局(「FDA」)正式批准開展用於診斷實體瘤的 I/II 期臨 床研究，這標誌著本集團在核藥抗腫瘤診療領域的全球化佈局上又邁出堅實一步。作為 本集團首款獲得 FDA 批准開展臨床研究的自研 RDC 產品，GPN01530 臨床研究的成功 獲批為本集團核藥產品管線的國際化開發提供了重要範式，是本集團核藥抗腫瘤診療板 塊全球化研發與註冊進程中的重要里程碑，充分體現了本集團在前沿核藥技術平台建設、 國際化臨床開發與註冊申報等方面的綜合實力。本集團將依託「中美雙報」的國際化註 冊路徑，持續推進 GPN01530 的全球研發與註冊工作，並以此為基礎，進一步深化該板 塊的全球化發展戰略，積極推動更多自主研發的創新核藥產品的國際臨床研究與註冊申 報工作，不斷提升本集團在核藥抗腫瘤診療領域的核心競爭力與 ...

Core Insights - ITM Isotope Technologies Munich SE has appointed Annette Breunig as Chief People Officer to enhance its human resources strategy and support organizational growth [1][2] - Breunig has over 25 years of HR leadership experience in international pharmaceutical and technology companies, including Siemens AG and Sanofi [1][2] - The company aims to improve outcomes for cancer patients through innovative radiopharmaceuticals, with a focus on employee empowerment and company culture [2][3] Company Overview - ITM is a leading radiopharmaceutical biotech company dedicated to developing therapeutics and diagnostics for hard-to-treat tumors [4] - The company is advancing a precision oncology pipeline, including multiple Phase 3 studies, to provide more effective targeted treatments [4] - ITM leverages two decades of expertise and a global network to improve clinical outcomes and quality of life for patients [4]

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].

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 - Cellectar Biosciences and ITM Isotope Technologies Munich have entered a supply agreement for Actinium-225 to support the clinical development of Cellectar's CLR 121225, a novel radiopharmaceutical for treating solid tumors, including pancreatic cancer [1][2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate delivery platform [5] - ITM Isotope Technologies Munich SE specializes in radiopharmaceuticals and aims to provide innovative therapeutics and diagnostics for hard-to-treat tumors, leveraging over two decades of expertise in medical isotope manufacturing [9] Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and CLR 121225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [6][7] - CLR 121225 is designed to selectively target and eradicate cancer cells using a proprietary PLE delivery platform [2][6] Strategic Partnership - The agreement between Cellectar and ITM ensures a continuous, high-quality supply of Actinium-225, which is crucial for advancing Cellectar's pipeline candidates and exploring the benefits of targeted alpha therapy for cancer patients [3][4] - ITM's joint venture, Actineer, is dedicated to advancing Ac-225 technologies and aims to meet the growing global demand for this critical isotope [10] Market Context - The scarcity of high-quality Ac-225 has hindered the development of Ac-225 based programs, prompting Cellectar to establish a network of suppliers to ensure sufficient access [3][4] - The partnership reflects a strategic commitment to enhancing global access to radiopharmaceuticals and improving patient outcomes through innovative therapies [4]

Core Insights - Radiopharm Theranostics is advancing its clinical pipeline with significant milestones, including FDA Fast Track Designation for RAD101 and clearance for higher dosing of RAD204 [3][5][6] - The company confirmed a cash runway extending through mid-2026, with a year-end cash balance of $29.12 million, up from $18.58 million the previous year [10][12] Program and Business Updates - RAD204, a nanobody targeting PD-L1, is on track for higher dosing at 60mCi of Lu177, with enrollment for the second cohort expected to complete soon [6] - RAD202, targeting HER2, has initiated its Phase 1 HEAT trial, with preliminary data anticipated by the end of 2025 [6] - The company has established supply agreements for key radioisotopes, enhancing its clinical trial capabilities [3][12] Financial Update - For the fiscal year ending June 30, 2025, net cash outflows from operating activities totaled $36.67 million, primarily due to research and development expenditures [10][12] - The company received $4.58 million for research and development tax incentives for the 2024 financial year [12]

Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* 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。 本集團全球創新放射性產品 SIR-Spheres®釔[ 90Y]微球注射液 提前正式獲得 FDA 批准新增適應症 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。 ( 於百慕達註冊成立之有限公司 ) (股份代號：00512) 自願性公告 SIR-Spheres®釔[ 90Y]微球注射液，是一款針對肝臟惡性腫瘤的選擇性內放射治療產品， 採用全球領先的介入技術將釔[ 90Y]樹脂微球注入肝臟腫瘤血管，釋放高能量 β 放射線 殺滅腫瘤細胞，兼具了放射性藥物和精准介入治療的雙重優勢。本次新適應症的獲批是 基於一項前瞻性、多中心、開放標籤的臨床試驗（「DOORwaY90」）的中期結果。該 試驗中期數據顯示，DOORwaY90 成功達到預先設定的共同主要終點：經獨立中 ...

Core Insights - ITM Isotope Technologies Munich SE and Radiopharm Theranostics have signed a supply agreement for non-carrier-added Lutetium-177 (n.c.a. Lu) to support Radiopharm's clinical and potential commercial development of Lu-based molecules [1][2] Company Overview - ITM is a leading radiopharmaceutical biotech company focused on developing therapeutics and diagnostics for hard-to-treat tumors, with a commitment to improving patient outcomes through high-quality radioisotopes [4] - Radiopharm Theranostics is a clinical-stage company developing innovative radiopharmaceutical products for diagnostic and therapeutic applications, with a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors [5] Agreement Details - The supply agreement allows Radiopharm to utilize ITM's n.c.a. Lu in key clinical programs, including RAD 204, RAD 202, and RV01, aimed at treating solid tumors [2][3] - ITM's n.c.a. Lu is a highly pure beta-emitting radioisotope that can be linked to tumor-specific targeting molecules, enhancing the precision of cancer treatment [3] Strategic Importance - The agreement is seen as a critical step for Radiopharm to ensure the quality and reliability of its clinical development plans, particularly for its advanced assets [3] - ITM emphasizes its commitment to supplying high-quality medical radioisotopes to both its partners and its own pipeline, reflecting a shared dedication to improving cancer treatment options [4]

Core Viewpoint - The company has made significant progress in the development of its innovative radiopharmaceutical TLX591-CDx for diagnosing prostate cancer, with plans to submit a new drug application in China within the year [1][4]. Group 1: Product Development and Clinical Trials - TLX591-CDx is a targeted diagnostic radiopharmaceutical that specifically binds to PSMA, which is highly expressed in prostate cancer, and has several advantageous characteristics [2]. - The Phase III clinical trial in China has successfully completed patient enrollment, which is expected to accelerate the product's market entry in China [4]. - The product has received regulatory approvals in multiple countries, including Australia, the United States, and Canada, with significant sales growth reported [3]. Group 2: Market Position and Pipeline - The company has a robust pipeline with 15 innovative products in the nuclear medicine oncology sector, covering various cancers and offering both diagnostic and therapeutic options [5]. - The company is recognized for having the largest reserve of RDC innovative drugs in Phase III clinical research in China, positioning itself as a leader in the nuclear medicine oncology field [5]. Group 3: Research and Development Infrastructure - The company has established a comprehensive nuclear medicine oncology platform, including R&D, production, and regulatory capabilities, supported by international collaborations [6]. - The establishment of the Faraday Medical-Shandong University Radiopharmaceutical Research Institute marks a significant step in building an early-stage R&D platform for radiopharmaceuticals [6].

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 本集團全球創新放射性核素偶聯藥物 TLX591 加入國際多中心 III 期臨床試驗的申請已獲中國藥監局受理 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，本集團用於治療前列腺癌的全球創新放射性核素偶聯藥物(「RDC」) TLX591 (177Lu- HuJ591)加入國際多中心 III 期臨床試驗的申請，近日已獲得中華人民共 和國國家藥品監督管理局(「中國藥監局」)正式受理，這是本集團在核藥抗腫瘤診療領 域的重要研發進展。本集團高度重視核藥產業全球化發展戰略，積極推進創新核藥產品 的全球化開發及註冊進程，並將持續深化本集團核藥產品管線的全球化拓展。 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。 該研究是一項前 ...