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) 補充及澄清公告 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 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。 茲提述本公司於二零二五年十二月三十一日刊發有關股份購買協議項下擬進行交易之關連 交易之公告（「該公告」）。除另有說明外，本補充公告所用詞彙與該公告所界定者具 有相同涵義。 誠如公告所披露，本次交易之代價人民幣 316,000,000 元乃經買方與賣方參考下列因素後， 經公平磋商釐定：(i)目標公司之財務表現、業務增長及前景（包括現有資產、研發進程中 之技術專長及研發項目之未來前景）； (ii) 獨立合資格估值師根據市場法編製之估值報告， 據此，於扣除建議向賣方分派之利潤人民幣 134,000,000元後，目標公司 100%股權於 2025 年 9 月 30 ...

Market Performance - The Hong Kong stock market experienced a decline, with the Hang Seng Index falling by 0.29% to 26,487.51 points, the Hang Seng Tech Index down 1.16% to 5,683.44 points, and the National Enterprises Index decreasing by 0.43% to 9,094.76 points [1] - Major technology stocks generally declined, with Alibaba down 0.44%, Tencent down 1.48%, and Xiaomi down 2.74%, while JD.com saw a slight increase of 0.09% [1] - New consumption concept stocks performed well, with Pop Mart rising by 9% and Naixue's Tea increasing by over 4% [1] Corporate News - Codex-B (02487.HK) reported positive top-line results from a Phase III clinical trial for CU-20101, an injectable botulinum toxin type A for moderate to severe glabellar lines [2] - Saint Bella (02508.HK) entered a strategic cooperation framework agreement with Cloudwise Technology to explore the integration of AI and robotics in high-demand home care scenarios [2] Profit Forecasts - China Taiping (00966.HK) expects a net profit increase of approximately 215% to 225% in 2025, compared to 8.432 billion HKD in the previous year [3] - TCL Electronics (01070.HK) anticipates an adjusted net profit of approximately 2.33 billion to 2.57 billion HKD in 2025, representing a growth of 45% to 60% [3] - Jihong Co. (02603.HK) forecasts a net profit of approximately 273 million to 291 million RMB in 2025, a year-on-year increase of 50% to 60% [3] - Guolian Minsheng (01456.HK) expects a net profit of 2.008 billion RMB in 2025, a growth of around 406% [3] - China Railway (00390.HK) reported a new contract amount of 1,165.98 billion RMB in Q4 2025, with a cumulative new contract amount of 2,750.9 billion RMB, a year-on-year growth of 1.3% [3] Sales and Revenue - Shenzhen Holdings (00604.HK) anticipates a total contract sales amount of approximately 13.311 billion RMB in 2025, a decrease of 21.55% [4] - SF Holding (06936.HK) reported a total revenue of 27.339 billion RMB in December from its logistics, supply chain, and international businesses, reflecting a year-on-year growth of 3.41% [5] Institutional Insights - Dongwu Securities noted that the Hong Kong market is in a long-term upward trend but faces short-term challenges, with strong consensus on domestic fundamentals but mixed views on overseas factors [9] - Huaxia Fund emphasized the high sensitivity of the Hong Kong market to corporate earnings and macroeconomic data, suggesting that positive economic surprises could significantly boost market expectations [10] - Tianfeng Securities highlighted that the Hong Kong market has the foundation for a rebound due to valuation recovery and sentiment improvement, but upward momentum may be constrained by high overseas interest rates [10] - Huaxi Securities pointed out that the "AI+" logic is catalyzing valuation optimization in the Hong Kong market, with a focus on internet, technology, and emerging consumption sectors [10]

Core Viewpoint - The announcement by Yuan Da Pharmaceutical regarding the acceptance of its new drug application for the innovative radiopharmaceutical conjugate drug TLX591-CDx marks a significant advancement in the field of nuclear medicine for cancer diagnosis, particularly for prostate cancer patients in China [1]. Company Summary - Yuan Da Pharmaceutical has submitted a new drug application (NDA) for TLX591-CDx to the National Medical Products Administration, which has been accepted [1]. - This development is expected to enhance the company's product pipeline in the nuclear medicine sector, specifically targeting tumor diagnosis [1]. Industry Summary - The acceptance of TLX591-CDx signifies the introduction of a globally leading precision diagnostic tool for prostate cancer, which could facilitate early detection, precise classification, and optimization of treatment plans for patients [1].

Group 1: Major Developments - 康耐特光学 (02276) and 歌尔光学 plan to establish a joint venture to expand the application market for customized lenses in AI/AR/VR/MR glasses [1] - 圣贝拉 (02508) and 云迹科技 signed a strategic cooperation framework agreement to explore the deep integration and application of artificial intelligence and robotics in high-demand home care scenarios [1] - KKCG Maritime intends to initiate a voluntary conditional partial public acquisition offer to acquire 15.4% of 法拉帝 (09638) shares [1] - 远大医药 (00512) announced that the new drug application for the innovative radiolabeled drug TLX591-CDx has been accepted by the China National Medical Products Administration [1] - 艾美疫苗 (06660) received approval to conduct clinical trials for a 20-valent pneumococcal polysaccharide conjugate vaccine [1] - 中国东方航空股份 (00670) sold the 凯迪克大厦 in Shanghai and related assets to 东航置业 for approximately 134 million yuan [1] - 佑驾创新 (02431) signed a memorandum of understanding with India's leading automotive parts manufacturer STL [1] - 南山铝业国际 (02610) plans to develop electrolytic aluminum and related raw materials and supporting businesses [1] Group 2: Financial Performance - 顺丰控股 (06936) reported a total revenue of 27.339 billion yuan from its express logistics, supply chain, and international businesses in December, representing a year-on-year increase of 3.41% [2] - 美丽田园医疗健康 (02373) issued a profit warning, expecting adjusted net profit for 2025 to be no less than 380 million yuan, a year-on-year increase of at least 40% [2] - 中国太平 (00966) issued a profit warning, anticipating a year-on-year increase of approximately 215% to 225% in shareholder profit for the 2025 fiscal year [2] - 吉宏股份 (02603) issued a profit warning, expecting a net profit attributable to shareholders of approximately 273 million to 291 million yuan for 2025, a year-on-year increase of 50% to 60% [2] - 兖煤澳大利亚 (03668) reported a fourth-quarter coal sales volume of 10.8 million tons, a year-on-year increase of 4% [2] - 兖矿能源 (01171) reported a fourth-quarter commodity coal production of 46.51 million tons, a year-on-year increase of 4.4% [2] - 深圳控股 (00604) projected a total contract sales amount of approximately 13.311 billion yuan for 2025, a year-on-year decrease of 21.55% [2] - 上海石油化工股份 (00338) issued a profit warning, expecting a net loss attributable to shareholders of approximately 1.289 billion to 1.576 billion yuan for 2025, indicating a shift from profit to loss [2] - 上海石油化工股份 (00338) reported gasoline sales revenue of 24.656 billion yuan for 2025 [2]

Core Viewpoint - The acceptance of the new drug application (NDA) for TLX591-CDx by the National Medical Products Administration marks a significant advancement for the company in the field of nuclear medicine for cancer diagnosis [1][2]. Group 1: Product Development and Market Potential - TLX591-CDx is a diagnostic radiopharmaceutical targeting prostate-specific membrane antigen (PSMA), suitable for diagnosing both newly diagnosed and recurrent prostate cancer [1]. - The NDA application includes data from a clinical study conducted in China, which is a Phase III open-label study involving over 100 patients with biochemical recurrence of prostate cancer [1]. - The incidence of prostate cancer in China is on the rise, with projections indicating nearly 200,000 new cases by 2030 according to Frost & Sullivan data [1]. Group 2: Commercial Performance and Expansion - TLX591-CDx has been approved for commercialization in 24 countries, including Australia, the USA, and several European nations, demonstrating strong commercial performance with sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting a year-on-year growth of over 25% [2]. - The acceptance of the NDA is a crucial step in the company's strategy to build an integrated diagnostic and therapeutic product portfolio for prostate cancer, with the complementary therapeutic product TLX591 already approved for international Phase III clinical studies in China [2]. Group 3: Strategic Positioning and Future Outlook - The company has established a comprehensive layout in the nuclear medicine sector, covering research and development, production, distribution, and sales [2]. - The ongoing "Go Global" strategy and the anticipated launch of TLX591-CDx and other innovative products are expected to enhance the company's core competitiveness in the nuclear medicine field [2].

Core Viewpoint - YuanDa Pharmaceutical has submitted a new drug application for TLX591-CDx, a novel radiopharmaceutical for diagnosing prostate cancer, to the National Medical Products Administration of China, which has been accepted [1] Group 1: Company Developments - TLX591-CDx is a globally innovative diagnostic radiopharmaceutical based on radiolabeled small molecule conjugate technology [1] - The drug targets prostate-specific membrane antigen and is suitable for diagnosing both newly diagnosed and recurrent prostate cancer [1]

Core Viewpoint - The acceptance of the new drug application (NDA) for TLX591-CDx by the National Medical Products Administration marks a significant advancement for the company in the nuclear medicine field, particularly for prostate cancer diagnosis, providing a leading-edge tool for early detection and treatment optimization [1][12]. Group 1: Market Potential and Clinical Data - Prostate cancer is increasingly prevalent in China, with an expected 200,000 new cases by 2030 and a market size projected to grow at a compound annual growth rate (CAGR) of approximately 21.8% to nearly 50.6 billion RMB [2][4]. - The overall positive predictive value (PPV) of TLX591-CDx in detecting tumors is reported at 94.8%, demonstrating its effectiveness compared to non-Chinese patient studies [9]. - Over 67.2% of patients had their treatment plans adjusted after undergoing PET imaging with TLX591-CDx, indicating its significant impact on clinical decision-making [9]. Group 2: Product Advantages and Technology - TLX591-CDx features a unique design with the PSMA-11 targeting agent, which binds specifically to PSMA expressed in prostate cancer, ensuring high diagnostic precision and safety [10][11]. - The product's characteristics include precise targeting, efficient imaging, and reliable safety, fulfilling clinical needs for early diagnosis and monitoring of prostate cancer [11]. Group 3: Strategic Development and Global Positioning - The acceptance of TLX591-CDx's NDA is a crucial step in the company's strategy to build an integrated diagnostic and therapeutic nuclear medicine product portfolio for prostate cancer [12]. - The company has established a comprehensive global layout in the nuclear medicine sector, with R&D and production bases in Boston and Chengdu, and a sales network covering over 50 countries [13]. - The company has a pipeline of 16 innovative products, including both diagnostic and therapeutic nuclear medicine options, aimed at various cancer types, enhancing its competitive edge [13]. Group 4: Future Outlook and Expansion - The successful international approval of the company's innovative small molecule RDC drug GPN01530 for clinical research signifies its strong clinical development capabilities and potential for future cancer imaging standards [16]. - The Chengdu production base, equipped with 14 high-standard GMP production lines, enables the company to meet diverse production needs and reduce reliance on imports, enhancing its operational efficiency [16]. - The ongoing "Go Global" strategy and the launch of innovative products like TLX591-CDx are expected to strengthen the company's competitive position in the global nuclear medicine market [17].

Core Insights - The submission of the New Drug Application (NDA) for TLX591-CDx by YuanDa Pharmaceutical marks a significant advancement in the field of nuclear medicine for prostate cancer diagnosis, indicating the potential for a leading global diagnostic tool for early detection and treatment optimization [1][12] Industry Overview - Prostate cancer is one of the most common cancers among men in China, with increasing incidence and mortality rates due to factors such as population aging. The number of new cases is projected to reach nearly 200,000 by 2030, with the drug market expected to grow at a compound annual growth rate (CAGR) of approximately 21.8%, reaching nearly 50.6 billion RMB [2][4] - The early detection rate of prostate cancer in China is low, with only 30% diagnosed at an early stage, leading to significantly lower five-year survival rates compared to the US and Japan [6] Product Advantages - TLX591-CDx has demonstrated a high positive predictive value (PPV) of 94.8% in clinical trials, confirming its diagnostic efficacy comparable to studies conducted on non-Chinese patients. The product maintains high diagnostic accuracy across various lesion types, even in patients with low PSA levels [9][10] - Over 67.2% of patients had their treatment plans adjusted based on TLX591-CDx PET imaging results, highlighting its significant impact on clinical decision-making [9] Technological Edge - The product's unique design features a targeted agent, PSMA-11, which binds specifically to PSMA expressed in prostate cancer, offering advantages such as high affinity, biological stability, and effective tumor penetration [10][11] - TLX591-CDx's characteristics of "precise targeting, efficient imaging, and safety" meet clinical needs for prostate cancer diagnosis and monitoring, providing strong evidence for its market application [11] Market Potential - TLX591-CDx has been approved for commercialization in 24 countries, including the US, Australia, and Canada, achieving impressive sales figures of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting over 25% year-on-year growth [11] - The acceptance of the NDA for TLX591-CDx is a crucial step in YuanDa Pharmaceutical's strategy to build an integrated diagnostic and therapeutic nuclear medicine product portfolio for prostate cancer [12] Strategic Development - YuanDa Pharmaceutical has established a comprehensive global layout in the nuclear medicine sector, with R&D and production bases in Boston and Chengdu, and a sales network covering over 50 countries [13] - The company has a pipeline of 16 innovative products targeting various cancers, including prostate cancer, and aims to provide integrated treatment options through its diagnostic and therapeutic products [13][17] Future Outlook - The successful NDA submission and ongoing development of TLX591-CDx and other innovative products are expected to enhance YuanDa Pharmaceutical's competitive edge in the global nuclear medicine market, contributing to improved treatment options for cancer patients worldwide [17]

Core Viewpoint - The company has made significant progress in the development of innovative radiopharmaceuticals for prostate cancer diagnosis and treatment, with the recent submission of a New Drug Application (NDA) for TLX591-CDx to the National Medical Products Administration of China, marking a key milestone in its oncology pipeline [1][2]. Group 1: Product Development and Clinical Trials - TLX591-CDx has shown a positive predictive value (PPV) of 94.8% in a clinical study involving over 100 prostate cancer patients, indicating its effectiveness in diagnosing the disease [2]. - The NDA submission includes data from a clinical study that demonstrated the impact of TLX591-CDx on treatment decisions, with 67.2% of patients experiencing changes in their treatment plans based on PET imaging results [2]. - The company has a total of six innovative RDC products approved for clinical research, with four currently in Phase III trials, including TLX591-CDx and TLX591 [8]. Group 2: Strategic Partnerships and Collaborations - The company signed a strategic cooperation agreement with Telix Pharmaceutical Limited in November 2020, securing exclusive rights to several innovative RDC products in Greater China [3]. - Collaborations with Sirtex Medical Pty Ltd and ITM Isotope Technologies Munich SE have established a world-class tumor intervention research and development platform [5]. Group 3: Market Expansion and Sales Performance - TLX591-CDx has been approved in multiple countries, including Australia, the United States, and Canada, with projected sales of approximately $517 million in 2024 and $461 million in the first three quarters of 2025, reflecting over 25% year-on-year growth [4]. - The company has established a global sales network covering over 50 countries, enhancing its market presence in the oncology sector [4]. Group 4: Infrastructure and Production Capabilities - The company’s radiopharmaceutical research and production base in Chengdu, China, is the first of its kind to cover the entire nuclear medicine supply chain, from isotope preparation to commercialization [9]. - The facility is designed to meet international standards with advanced automation and safety measures, ensuring high-quality production and operational efficiency [9]. Group 5: Commitment to Innovation and Future Development - The company emphasizes innovation and advanced technology development, focusing on unmet clinical needs and expanding its product pipeline [10]. - Plans are in place to strengthen the research and development of its oncology products, aiming to solidify its position as a leader in the global radiopharmaceutical market [9][10].

智通财经APP讯，远大医药(00512)发布公告，本集团用于诊断前列腺癌的创新在研放射性核素偶联药物 (RDC) TLX591-CDx (Illuccix®, gallium Ga 68 PSMA-11)近日正式向中华人民共和国国家药品监督管理局 (药监局)递交了新药上市申请(NDA)并获得了受理，这是本集团在核药抗肿瘤诊疗领域的重要研发进 展。此外，本集团用于治疗前列腺癌的 RDC 产品 TLX591 已在中国获批加入国际多中心III期临床研 究，未来，两款产品组合蓄势待发，有望为中国前列腺癌患者带来更为精准、高效的诊疗方案。 本次NDA申请包含了TLX591-CDx中国临床研究的数据，该研究于2025年12月公布了积极的初步结果， 该研究是一项单臂、开放标签的III期临床研究，在超过100例前列腺癌生化复发患者中使用 TLX591- CDx 并进行正电子发射断层成像/电脑断层扫描(PET/CT)或正电子发射断层成像/磁共振成像(PET/MRI) 检测，以评估产品的诊断有效性，同时评估产品在中国人群中的安全性和耐受性。根据临床顶线结果， TLX591 CDx 检测肿瘤的总体阳性预测值(PPV)达94.8%( ...