自願性公告 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) 此外，超過三分之二（67.2%）的患者在 TLX591-CDx 的 PET 成像檢測後，其治療方案 較基線時的初始方案發生了調整。這表明 TLX591-CDx 的 PET 成像檢測對臨床決策具 有重要影響，可優化疑似生化復發的前列腺癌患者的臨床治療策略。 此前，本集團於二零二零年十一月與 Telix Pharmaceutical Limited (ASX: TLX; NASDAQ: TLX，與其全球子公司統稱「Telix」)簽署了產品戰略合作協議，並獲得其開發的包括 TLX591、TLX591-CDx、TLX250-CDx 在內的多款創新 RDC 產品在大中華區（中國大 陸、中國香港特別行政區、中國澳門特別行政區、中國台灣地區）的獨家權益。 ...

Core Insights - The company has achieved significant breakthroughs in the field of nuclear medicine, particularly with the successful completion of the Phase I clinical trial of TLX250-CDx for diagnosing clear cell renal cell carcinoma (ccRCC) in China, which has been published in a leading international journal [1][6] - TLX250-CDx is expected to provide a non-invasive and accurate diagnostic option for millions of suspected ccRCC patients in China, enhancing the diagnostic landscape [1][6] Group 1: Clinical Research and Results - The ZIRDOSE-CP clinical study is a single-arm, open-label, prospective Phase I trial assessing the safety, tolerability, and pharmacokinetics of TLX250-CDx in 10 Chinese patients with uncertain renal masses or suspected recurrence of ccRCC [2] - The study demonstrated good safety and tolerability of TLX250-CDx in Chinese patients, with organ and tumor dosimetry similar to previous reports in other populations, supporting its clinical value [6][10] Group 2: Market Potential and Growth - The ccRCC market is expanding, with the number of patients in China increasing from 66,000 in 2015 to 81,000 in 2023, reflecting a compound annual growth rate (CAGR) of 2.0%, and projected to reach 93,000 by 2030 [2] - The global renal cancer diagnostic market is expected to grow from USD 5.37 billion in 2024 to USD 8.36 billion by 2035, with a CAGR of 4.11%, indicating a strong demand for more precise diagnostic methods [5] Group 3: Company Capabilities and Innovations - The company has established a comprehensive nuclear medicine industry chain, covering research, production, distribution, and sales, with over 900 employees globally [7][14] - The company has a robust pipeline with 16 innovative products in the registration phase, including five key radioactive isotopes, and aims to provide integrated treatment options for various cancers [7][10] - The company’s production facility in Chengdu is the world's first closed-loop platform for nuclear medicine, ensuring 100% self-production and addressing import dependency issues [12][14]

Core Insights - The company, YuanDa Pharmaceutical, has achieved significant breakthroughs in the field of nuclear medicine for cancer diagnosis, particularly with the successful completion of the Phase I clinical trial of TLX250-CDx for diagnosing clear cell renal cell carcinoma (ccRCC) in China [1][6]. Group 1: Clinical Research and Results - TLX250-CDx has demonstrated good safety and tolerability in Chinese patients, with organ and tumor dosimetry similar to previous reports in other populations, supporting its safety and efficacy for future registration and market launch in China [1][6]. - The ZIRDOSE-CP clinical study, a single-arm, open-label, prospective Phase I trial, evaluated the safety, tolerability, and pharmacokinetics of TLX250-CDx in 10 Chinese patients with uncertain renal masses or suspected recurrence of ccRCC [2][5]. - The sensitivity and specificity of TLX250-CDx for detecting ccRCC were reported at 85.5% and 87%, respectively, indicating its potential as a new clinical diagnostic standard [5][6]. Group 2: Market Potential and Growth - The ccRCC patient population is growing, with the incidence in China increasing from 66,000 in 2015 to 81,000 in 2023, reflecting a compound annual growth rate (CAGR) of 2.0%, and projected to reach 93,000 by 2030 [2]. - The global renal cancer diagnostic market is expected to grow from USD 5.37 billion in 2024 to USD 8.36 billion by 2035, with a CAGR of 4.11%, highlighting the demand for more precise and efficient diagnostic methods [5]. Group 3: Company Capabilities and Innovations - YuanDa Pharmaceutical has established a comprehensive nuclear medicine industry chain, covering research, production, distribution, and sales, with over 900 employees globally [7][14]. - The company has a strong pipeline of 16 innovative products in the registration phase, including five key radioactive isotopes, and aims to provide integrated treatment options for various cancers [7][10]. - The company’s production facility in Chengdu is the world's first closed-loop platform for nuclear medicine, ensuring 100% self-sufficiency in production and addressing import dependency issues [12][14].

Core Viewpoint - The company, YuanDa Pharmaceutical, has made significant advancements in innovative products, showcasing its "self-research + introduction" strategy in the fields of nuclear medicine, traditional Chinese medicine for depression, and emergency treatments, indicating a strong potential for sustainable growth in the innovative drug sector [1][16]. Group 1: Innovative Product Developments - The company achieved success in its Phase II clinical trial for an innovative traditional Chinese medicine for depression [1]. - The FDA approved the company's self-researched FAP-targeted nuclear medicine for clinical research, while an introduced prostate cancer diagnostic nuclear medicine reached the end of its Phase III clinical trial in China, indicating imminent commercialization [1][2]. - The company launched the world's first epinephrine nasal spray for emergency treatment of type I allergic reactions in China, enhancing its cardiovascular emergency product line [1][14]. Group 2: Nuclear Medicine Advancements - The GPN01530 nuclear medicine, targeting FAP, has shown superior performance compared to current cancer diagnostic products, with a sensitivity of 80%-90% for certain cancers, potentially replacing the mainstream product 18F-FDG [2][3]. - TLX591-CDx, a prostate cancer diagnostic nuclear medicine, achieved a positive top-line result in its Phase III clinical trial, demonstrating a 100% positive predictive value for recurrent prostate cancer [4][5]. - The company has a robust pipeline with 16 innovative products in the registration phase, covering various radioactive isotopes and cancer types, indicating a comprehensive approach to nuclear medicine [7]. Group 3: Strategic Initiatives - The company employs a dual strategy of "self-research + global introduction," enhancing its innovation capabilities and product offerings in the nuclear medicine sector [6][10]. - The establishment of a comprehensive global industrial network, including R&D and production bases in Boston and Chengdu, supports the company's competitive edge in the nuclear medicine market [10][13]. - The company's proactive "China-US dual reporting" strategy accelerates drug approvals in major markets, enhancing the international market value of its products [10]. Group 4: Financial Performance and Market Outlook - The company reported a significant increase in revenue from innovative and barrier products, accounting for approximately 51% of total revenue, reflecting a year-on-year increase of 14.9 percentage points [16]. - The global nuclear medicine market is projected to grow from approximately $10.65 billion in 2023 to $31.44 billion by 2033, with a compound annual growth rate of about 11.45%, positioning the company to benefit from this market expansion [13]. - The company's market capitalization has doubled since the beginning of the year, indicating strong market recognition of its innovative strategy and growth potential [16].

Investment Rating - The industry investment rating is "Outperform the Market," indicating an expected performance that exceeds the market by more than 5% over the next six months [29]. Core Insights - The report highlights that the national government will continue to support the renewal of medical equipment in 2026, which is expected to drive demand in the medical device sector. The focus is on high-end equipment and companies with significant performance improvements and international expansion, such as Mindray Medical, United Imaging, Aohua Endoscopy, and Kaili Medical [3]. - The report emphasizes the optimization of application conditions and review processes for equipment renewal projects, aiming to lower investment thresholds and enhance support for small and medium-sized enterprises [3]. - The ongoing policy for equipment renewal is anticipated to sustain a favorable bidding environment for medical devices, with a gradual improvement in performance as inventory clears [3]. Summary by Sections Industry Overview - The report discusses the government's announcement on December 30, 2025, regarding large-scale equipment renewal and the inclusion of various sectors, including healthcare, in the support framework for 2026 [3]. - It outlines the measures to improve the application process for equipment renewal, including stricter requirements for equipment depreciation and minimum usage periods [3]. Investment Opportunities - The report suggests focusing on companies that are expected to show significant performance improvements and have a leading international presence in the medical device sector [3]. - Specific companies recommended for investment include Mindray Medical, United Imaging, Aohua Endoscopy, and Kaili Medical, which are well-positioned to benefit from the anticipated demand for high-end medical equipment [3]. Market Performance - The medical sector has experienced a decline, with a reported drop of 2.06% in the last week, ranking 25th among 28 industries [8][18]. - The report notes that the medical device market is under pressure in the short term due to policy impacts, but improvements are expected as companies innovate and expand internationally [5].

致：香港交易及結算所有限公司 公司名稱: 遠大醫藥集團有限公司 呈交日期: 2026年1月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00512 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | | 增加 / 減少 (-) | | | | | | HKD | | | | 本月底結存 | | | 100,000,000,000 | HKD | | 0.01 HKD | | 1,000,000,000 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 本月底法定/註冊股本總額： HKD ...

Group 1 - The core point of the article is that Yuan Da Pharmaceutical is strategically expanding its biotechnology sector by acquiring Hebei Yuan Da Jiu Fu Biotechnology Co., thereby enhancing its amino acid industry chain layout [1] - The acquisition will improve the stability of upstream amino acid raw material supply, enrich the midstream product pipeline, and accelerate market penetration of downstream health products, achieving synergistic development of the industry chain [1][6] - This move is expected to strengthen the company's competitive edge and global market influence, laying a solid foundation for its diversified development strategy in the biotechnology field [1][4] Group 2 - The amino acid industry is experiencing significant growth, with the global market size reaching approximately $26.19 billion in 2021 and projected to grow at a compound annual growth rate of about 7.5% to approximately $49.42 billion by 2030 [2] - China holds a dominant position in the global amino acid market, accounting for 32.23% of the market share in 2020, making it the largest producer and consumer of amino acids [2][4] - Yuan Da Pharmaceutical has over 20 years of experience in the amino acid sector, with a diverse product matrix and strong technical advantages, including nearly 50 types of amino acids and the highest number of registered amino acid raw material numbers in China [4][5] Group 3 - The company has established a comprehensive sales network, serving high-quality clients, including Fortune 500 companies, with approximately 40% of its business coming from overseas markets [5] - In the first half of 2025, the amino acid segment (including taurine) generated revenue of HKD 1.347 billion, solidifying the company's leading position in the amino acid industry [5] - The acquisition will allow Yuan Da Pharmaceutical to quickly gain advanced production technologies, quality customer resources, and mature sales channels, enhancing efficiency in raw material procurement, production collaboration, and market expansion [7][8] Group 4 - The acquired company possesses unique technical advantages and a diverse product pipeline in the amino acid field, contributing to a complete industry chain from raw materials to end health products [6][8] - The integration of the acquired company's mature technologies in fermentation and enzyme engineering with Yuan Da's synthetic biology technology platform will further strengthen technical barriers [8] - The company aims to focus on high-value areas such as high-end parenteral nutrition formulations, innovative peptide drugs, and health-related products, continuously enhancing its core competitiveness in high-quality amino acids [8]

Core Viewpoint - The company, Yuan Da Pharmaceutical (00512.HK), announced the acquisition of two companies for a total consideration of RMB 316 million, which will enhance its portfolio in the amino acid and thiol product sectors [1] Group 1: Acquisition Details - The acquisition involves Hubei Yuan Da, a subsidiary in which the company holds a 99.84% indirect non-wholly owned interest, as the buyer [1] - The sellers are China Yuan Da Group Co., Ltd. and Wuhan Jiu Xiang Biotechnology Partnership (Limited Partnership) [1] - The target companies include Hebei Yuan Da Jiu Fu Biotechnology Co., Ltd., established in 2004, focusing on the production and sales of amino acid products, and Baoding Jia He Fine Chemical Co., Ltd., established in 2005, specializing in the processing, manufacturing, and sales of thiol products [1]

Core Viewpoint - The acquisition of Hebei Yuanda Jiufu Biotechnology Co., Ltd. by Yuanda Pharmaceutical marks a significant strategic expansion in the biotechnology sector, particularly in the amino acid segment, enhancing the company's supply chain stability and market penetration capabilities [1] Group 1: Company Strategy and Expansion - The acquisition integrates the entire supply chain of the amino acid sector, allowing for improved production technology and market channel consolidation [1] - This strategic move aims to strengthen the company's competitive edge and global market influence, laying a solid foundation for diversified development in the biotechnology field [1][6] Group 2: Industry Overview - The global amino acid market reached approximately $26.19 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of about 7.5%, reaching around $49.42 billion by 2030 [2] - China holds a significant position in the global amino acid industry, accounting for 32.23% of the market share in 2020, making it the largest producer and consumer of amino acids [2] Group 3: Company Position and Product Offering - Yuanda Pharmaceutical has over 20 years of experience in the amino acid sector, with a diverse product matrix of nearly 50 types of amino acids and the highest number of registered amino acid raw material numbers in China [4] - The company has developed advanced production technologies, including synthetic biology and fermentation engineering, establishing a unique technical advantage in the industry [4][8] Group 4: Market and Sales Channels - The company has a well-established sales network, serving high-quality clients, including Fortune 500 companies, with approximately 40% of its business coming from overseas markets [5] - In the first half of 2025, the amino acid segment generated revenue of HKD 1.347 billion, reinforcing the company's leading position in the industry [5] Group 5: Future Outlook and Innovation - The acquisition will enable Yuanda Pharmaceutical to enhance its production efficiency, reduce operational costs, and improve market share through the integration of advanced technologies and customer resources [7][8] - The company plans to focus on high-value areas such as high-end parenteral nutrition formulations, innovative peptide drugs, and health-related products, further solidifying its leadership in the amino acid sector [8]

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。 ( 於百慕達註冊成立之有限公司 ) (股份代號: 00512) 關連交易 收購河北遠大九孚生物科技有限公司及 保定加合精細化工有限公司全部股權 於二零二五年十二月三十一日，湖北遠大作為買方與兩位賣方訂立了股權購買協議，據 此賣方同意出售及湖北遠大同意收購目標公司的 100%，總代價為人民幣 316,000,000 元。待完成股權購買協議後，目標公司將會成為本公司之間接非全資附屬公司。 於本公告日期，賣方 I 為中國遠大 (為本公司主要股東，持有本公司 53.42%股權)。因 此，根據上市規則 14A 章賣方 I 為本公司之關連人士，而根據上市規則 14A 章交易事項 構成本公司之關連交易。 因為交易事項之一個或多個適用百分比率(定義見上市規則 14.07 條)超過 0.1%但所有適 用比率少於 5%，交易事項需遵循上市規則 14A 章之報告及公告要求，但獲豁免通函及 獨立股東批准之要求。 Grand Ph ...