智通财经APP讯，远大医药(00512)发布公告，集团自主研发的全球创新放射性核素偶联药物(RDC) GPN01530 近日获得美国食品药品监督管理局(FDA)正式批准开展用于诊断实体瘤的 I/II 期临床研究， 这标志着集团在核药抗肿瘤诊疗领域的全球化布局上又迈出坚实一步。作为集团首款获得 FDA 批准开 展临床研究的自研 RDC 产品，GPN01530 临床研究的成功获批为集团核药产品管线的国际化开发提供 了重要范式，是集团核药抗肿瘤诊疗板块全球化研发与注册进程中的重要里程碑，充分体现了集团在前 沿核药技术平台建设、国际化临床开发与注册申报等方面的综合实力。集团将依托"中美双报"的国际化 注册路径，持续推进 GPN01530 的全球研发与注册工作，并以此为基础，进一步深化该板块的全球化发 展战略，积极推动更多自主研发的创新核药产品的国际临床研究与注册申报工作，不断提升集团在核药 抗肿瘤诊疗领域的核心竞争力与国际影响力。 ...

Core Viewpoint - The approval of GPN01530 by the FDA for clinical research marks a significant milestone in the company's global strategy for nuclear medicine in oncology, enhancing its competitive edge and international influence in the field [1]. Group 1: Product Development - GPN01530 is a small molecule RDC drug targeting Fibroblast Activation Protein (FAP), a key marker in cancer-associated fibroblasts, which plays a role in tumor growth and invasion [2]. - The drug has shown improved tumor targeting and pharmacokinetic properties compared to other FAP ligands, indicating its potential for better diagnostic efficacy in various malignancies [2][3]. Group 2: Clinical Research and Efficacy - Initial human studies indicate that GPN01530 has good safety profiles, with rapid background clearance and strong, sustained tumor uptake, outperforming traditional imaging agents like F-FDG in clinical image contrast and accuracy of positive lesion detection [3]. - The product's development is expected to provide a new diagnostic solution for a wide range of solid tumor patients, significantly enhancing the diagnostic capabilities of FAP-targeted RDC drugs [3].

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 ...

Group 1: Industry Developments - China's medical isotope self-sufficiency has made significant progress, with the establishment of a complete eco-friendly autonomous industrial chain for iodine-131 production, including precursor preparation, reactor irradiation, and nuclear drug development [1] - The global nuclear medicine market is projected to reach nearly $39 billion by 2032, indicating strong growth potential in the sector [1] - The number of approved radiotherapy devices in China has exceeded 90, with over 70% being domestically produced, marking a shift from reliance on imports [2] Group 2: Company Updates - China National Nuclear Corporation's subsidiary, Atomic High-Tech Co., has signed a commercial cooperation agreement with Novartis for the radioligand therapy drug, which is the first approved targeted PSMA therapy for advanced prostate cancer in China [3] - Yuan Da Pharmaceutical has 15 innovative nuclear drugs in the R&D registration phase, with a significant revenue increase in its nuclear medicine segment, achieving approximately HKD 420 million in revenue, a year-on-year growth of nearly 106% [3] - Sillod Medical has completed the first patient dosing in a study for its radiolabeled drug, 177Lu-PSMA-3D1015, aimed at treating metastatic castration-resistant prostate cancer, positioning it as a potential best-in-class product [4]

Group 1: Medical Isotope Production - China National Nuclear Corporation (CNNC) has successfully developed a complete technology chain for the irradiation preparation of iodine-131, enhancing the self-sufficiency of medical isotopes in China [1] - The technology includes the preparation of precursor isotopes, reactor irradiation, and nuclear drug development, forming an environmentally friendly and autonomous industrial chain [1] - The successful production of high-purity tellurium-130 isotopes with over 99% abundance fills a gap in the domestic large-scale preparation of high-purity enriched tellurium isotopes [1] Group 2: Radiation Therapy Equipment and Drug Development - As of 2024, over 90 radiotherapy devices have been approved by the National Medical Products Administration, with more than 70% being domestic brands, significantly reducing reliance on imported equipment [2] - The development of new radiopharmaceuticals has accelerated, with over 200 pipelines entering clinical trials, introducing new isotopes like lutetium-177 and yttrium-90 for more precise cancer treatment options [2] Group 3: Corporate Transactions and Financial Updates - WuXi AppTec has completed the sale of its subsidiary, expecting a post-tax net profit of approximately 960 million yuan, which accounts for over 10% of the company's latest audited net profit attributable to shareholders [5][6] - Guolian Minsheng has terminated a 480 million yuan fund establishment transaction, with no adverse effects on the company's finances or shareholder rights [7] - Morning Paper Industry plans to sell all shares of a target company for 3.336 billion yuan [10] Group 4: New Technologies and Innovations - GAC Group's flying car, GOVY AirCab, has entered the airworthiness certification stage and is expected to be mass-produced by 2026, aiming to create a new mode of transportation that integrates air and ground travel [17] - China Tongyuan has signed a commercial cooperation agreement with Novartis for the radiopharmaceutical product, providing a new treatment option for advanced prostate cancer patients [18]

Core Viewpoint - Company Yuanda Pharmaceutical (00512) is experiencing continuous revenue growth driven by the gradual launch of innovative products and efficient management, with a target price of HKD 11.88, representing a 45.23% upside potential based on an 18x PE for 2026 [1] Revenue Growth - In the first half of 2025, the company achieved total revenue of HKD 6.11 billion, with a year-on-year growth of 2.0% in RMB terms; normalized profit was HKD 1.02 billion, down 5.0% in RMB terms [2] - The pharmaceutical technology segment contributed the most, generating revenue of HKD 3.845 billion, with a year-on-year increase of 2.9% in RMB terms [2] - Revenue from nuclear medicine for tumor diagnosis and treatment reached HKD 420 million, showing a significant year-on-year growth of 105.5%, primarily driven by the approval of SIR-Spheres Yttrium-90 microspheres for treating unresectable HCC [2] Innovative Drug Pipeline - The company has five major technology platforms and eight R&D centers, with R&D and project investment of HKD 1.02 billion in the first half of 2025 [3] - The focus is on innovative nuclear medicine, with a leading global pipeline that includes radiolabeled drug conjugates (RDC) and interventional oncology products, with 27 innovative drug candidates currently in development [3] - The innovative drug STC3141 for treating sepsis has reached clinical endpoints in Phase II trials in China, showing significant improvement in SOFA scores compared to the placebo group [3] Profit Forecast - Future revenue growth is expected, with projected revenues of HKD 12.35 billion, HKD 13.39 billion, and HKD 14.79 billion for 2024 to 2026, respectively; EPS is forecasted to be HKD 0.59, HKD 0.66, and HKD 0.77 [4]

Core Viewpoint - Yuan Da Pharmaceutical (00512) is experiencing continuous revenue growth driven by the gradual launch of innovative products and efficient management, with a target price of HKD 11.88, indicating a potential upside of 45.23% from the current price, maintaining a buy rating [1] Group 1: Revenue Growth - The company achieved total revenue of HKD 6.11 billion in the first half of 2025, representing a year-on-year increase of 2.0% in RMB terms; normalized profit was HKD 1.02 billion, down 5.0% year-on-year in RMB terms [2] - The pharmaceutical technology segment contributed the most to revenue, generating HKD 3.845 billion, with a year-on-year increase of 2.9% in RMB terms [2] - Revenue from nuclear medicine for tumor diagnosis and treatment reached HKD 420 million, showing a significant year-on-year growth of 105.5%, primarily driven by the approval of SIR-Spheres Yttrium-90 microspheres for unresectable HCC [2] Group 2: Innovative Drug Pipeline - The company has five major technology platforms and eight R&D centers, with R&D and project investment of HKD 1.02 billion in the first half of 2025 [3] - The focus is on innovative nuclear medicine, with a leading global pipeline that includes radiolabeled drug conjugates (RDC) and interventional oncology products, with 27 innovative drug candidates currently in development [3] - The innovative drug STC3141 for treating sepsis has reached clinical endpoints in Phase II trials in China, showing significant improvement in SOFA scores compared to the placebo group [3] Group 3: Profit Forecast - Future revenue growth is expected, with projected revenues of HKD 12.35 billion, HKD 13.39 billion, and HKD 14.79 billion for 2024 to 2026, respectively; EPS is forecasted to be HKD 0.59, HKD 0.66, and HKD 0.77 for the same period [4]

Core Insights - The pharmaceutical and biotechnology index experienced a decline of 0.64% during the week, underperforming the Shanghai Composite Index by 1.34 percentage points, ending a two-week upward trend [4] - The National Healthcare Security Administration released the 2025 National Basic Medical Insurance Drug List, which included 114 products, achieving a success rate of 88% in negotiations, the highest in recent years [5] - The launch of the commercial health insurance innovative drug list included 19 drugs, complementing the basic medical insurance list and indicating a shift towards a multi-tiered healthcare system in China [5][19] Weekly Market Performance - The A-share market saw significant gains for Haiwang Bio, which rose by 71.20%, while Zhongsheng Pharmaceutical increased by 15.56% [2] - In the Hong Kong market, Jinxin Reproductive Medicine and Boan Biotechnology saw increases of 7.53% and 8.62%, respectively [2] Clinical Trials and Innovations - Kangfang Biopharma's dual-antibody drug, Kadunilumab, has initiated a Phase II clinical trial for esophageal squamous cell carcinoma, a prevalent cancer type in China [13][14] - A clinical trial for a gout treatment, polyethylene glycol-uricase injection (HZBio1), has also commenced, targeting patients with poorly controlled uric acid levels [17][18] New Drug Developments - Baoyi Pharmaceutical's stock surged nearly 140% on its first trading day, with a market capitalization of HKD 20.5 billion, despite a significant net loss of CNY 183 million in the first half of 2025 [6][7] - The company has 12 self-developed products, with SJ02 being the first long-acting FSH-CTP product approved in China [7] Industry Trends - The trend of "innovation + internationalization" remains a core direction for the pharmaceutical sector, supported by policies and increasing global competitiveness [5] - The demand for more effective and safer uric acid-lowering drugs is rising due to the increasing prevalence of gout, particularly among younger populations in China [18]

每经AI快讯，远大医药(00512.HK)盘中一度涨超3%，截至发稿涨2.59%，报8.32港元，成交额3337.37万 港元。 ...

Core Viewpoint - Yuan Da Pharmaceutical (00512) has seen a stock price increase of over 3% during trading, currently up 2.59% at HKD 8.32, with a trading volume of HKD 33.37 million. The company recently announced that its innovative traditional Chinese medicine GPN01360 for treating depression has reached clinical endpoints in a Phase II clinical study in China [1]. Group 1: Clinical Research and Product Development - GPN01360 is a Class 1 innovative traditional Chinese medicine designed to treat depression (specifically liver qi stagnation and spleen deficiency syndrome), based on the ancient formula "Xiao Yao San" [1]. - The formulation consists of 12 traditional Chinese medicinal ingredients, including Chai Hu, Yu Jin, and Fo Shou, which are believed to have effects such as soothing the liver, strengthening the spleen, and calming the mind [1]. - Positive clinical research data is expected to lay a foundation for the further development of GPN01360, potentially addressing the issue of poor patient compliance associated with side effects of existing Western medications [1]. Group 2: Market Implications and Evidence - The innovative approach of GPN01360 may enhance the sustainability and effectiveness of long-term treatment for depression, contributing to improved clinical cure rates [1]. - GPN01360 is anticipated to provide robust evidence for the efficacy of traditional Chinese medicine in treating mental health disorders, validating the unique advantages and scientific value of traditional Chinese formulations [1].