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 曲前列尼爾注射液（20ml : 50mg）獲頒發藥品註冊證書 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，本集團用於治療肺動脈高壓（pulmonary arterial hypertension， 「PAH」，WHO 分類 1）的產品曲前列尼爾注射液的新規格（20ml : 50mg），近日獲 得中華人民共和國國家藥品監督管理局（中國藥監局）頒發藥品註冊證書，本產品 20ml:20mg 的規格已於二零二三年三月獲批上市。本產品爲醫保目錄產品，兩種規格 將有助於臨床醫生根據患者的情況提供更加精准的治療方案，這是本集團在心腦血管 急救領域罕見病方向的重大進展。 本集 ...

Investment Rating - The report maintains an "Outperform" rating for the biopharmaceutical industry [1] Core Viewpoints - The growth of healthcare expenses, which reached 9.06 trillion yuan in 2023, is outpacing GDP growth, indicating that commercial health insurance may provide a solution to the pressures faced by the medical insurance system [3][15] - The commercial health insurance sector is expected to grow significantly, with premiums projected to reach 97.74 billion yuan by 2024, driven by low penetration rates and the need for additional funding sources [20][24] - Policies are increasingly supportive of commercial health insurance, particularly in relation to innovative drugs, which are now being included in the commercial health insurance directory [71][76] Summary by Sections Part 1: Healthcare Financing System - The healthcare financing system in China consists of government, social, and personal contributions, with social contributions being the main driver for future growth [10][15] Part 2: Growth of Health Insurance - The commercial health insurance market is expected to fill a significant funding gap, with an estimated shortfall of over 1.7 trillion yuan by 2030 [21][22] - Medical insurance is the primary source of compensation within commercial health insurance, with a compensation rate of approximately 68.79% in 2022 [27][31] Part 3: Core Products of Medical Insurance - The report highlights the importance of medical insurance as a key focus area, noting that it directly compensates for medical expenses, unlike critical illness insurance [31][35] Part 4: Policy Support for Health Insurance Development - A series of policies since 2009 have aimed to promote the development of commercial health insurance, with specific targets for market size and coverage [71][72] Part 5: Investment Recommendations - The report suggests focusing on innovative drug companies with rich pipelines, DTP pharmacies, and companies in the TPA industry, as well as innovative medical devices and high-end medical service providers [77]

Core Insights - The recent clinical study of Yuan Da Pharmaceutical's product, Chen Nuo (Eucalyptus Oil Enteric Capsules), has been recognized by an international journal, marking a significant milestone in its evidence-based medical validation [1][3][10] - The study demonstrated the safety and efficacy of Chen Nuo in treating chronic rhinosinusitis over an 8-week period, reinforcing the company's research capabilities in the respiratory field [3][5][7] Product and Market Position - Chen Nuo is a core product in Yuan Da Pharmaceutical's respiratory and critical care segment, recognized for its mucolytic properties and has been included in China's national medical insurance and essential drug lists since 2017 and 2018 respectively [4][10] - The clinical trial involved over 300 patients across 13 hospitals, comparing the efficacy of Chen Nuo combined with Budesonide nasal spray against Budesonide alone [4][5] Clinical Study Results - Results indicated that the combination therapy group showed a statistically significant improvement in symptom control rates compared to the control group, particularly in nasal congestion and discharge by the 8th week [5][7] - The study also highlighted the advantages of the combination therapy for chronic rhinosinusitis patients with a history of smoking, showing greater improvement in CT Lund-Mackay scores [5][7] Future Market Potential - The research supports the inclusion of Chen Nuo in standardized treatment pathways for chronic rhinosinusitis, potentially benefiting over 100 million patients in China, especially those with smoking histories [7] - The global respiratory drug market is projected to reach approximately $99.9 billion by 2024, with the Chinese market expected to grow from about $11.6 billion to $13.8 billion by 2028, at a compound annual growth rate of 4.5% [7][8] Product Pipeline and Innovation - Yuan Da Pharmaceutical has developed a comprehensive product portfolio in the respiratory and critical care sectors, including treatments for various respiratory diseases and conditions [11][12] - The company is advancing multiple innovative products, including Ryaltris for allergic rhinitis and STC3141 for sepsis, which are expected to enhance its competitive position in the market [12][16] Strategic Development - The company emphasizes innovation and advanced technology in its R&D strategy, aiming to establish a full-cycle management product cluster for chronic respiratory diseases and critical care [16]

Core Viewpoint - The recent clinical study of Yuan Da Pharmaceutical's Cheno® (Eucalyptol enteric-coated capsules) for chronic rhinosinusitis has been recognized by an international journal, marking a significant milestone in the product's evidence-based medical validation [1][3]. Product and Clinical Research - Cheno® is a core product in Yuan Da Pharmaceutical's respiratory and critical care segment, recognized for its mucolytic properties and has been included in China's national medical insurance and essential drug lists since 2017 and 2018 respectively [4][5]. - The study involved over 300 chronic rhinosinusitis patients across 13 top-tier hospitals in China, comparing the efficacy and safety of Cheno® combined with Budesonide nasal spray against Budesonide alone [4][5]. Study Results - The results indicated that the combination therapy group showed a statistically significant improvement in major symptom scores and symptom control rates compared to the control group [5]. - Notably, the combination therapy was particularly effective for chronic rhinosinusitis patients with a smoking history, demonstrating superior improvement in CT Lund-Mackay scores [5][6]. - The safety profile of Cheno® was confirmed, with no significant difference in adverse event rates compared to the control group [5][6]. Market Position and Future Potential - The study reinforces Cheno®'s clinical value and supports its inclusion in standardized treatment pathways for chronic rhinosinusitis, potentially benefiting over 100 million patients in China, especially those with a smoking history [6]. - Cheno® is not only indicated for chronic rhinosinusitis but also has applications in various respiratory diseases, indicating a vast market potential [6]. - The global respiratory drug market is projected to reach approximately $99.9 billion by 2024, with the Chinese market expected to grow from $11.6 billion to $13.8 billion by 2028 at a CAGR of 4.5% [6]. Product Pipeline and Innovation - Yuan Da Pharmaceutical has developed a comprehensive product portfolio in the respiratory and critical care sectors, including innovative formulations for asthma and allergic rhinitis, with several products recently entering the national medical insurance list [11][12]. - The company is also advancing its pipeline with promising candidates for sepsis and other critical conditions, enhancing its competitive edge in the market [12][13]. - The strategic focus on innovation and global expansion aims to solidify the company's position in the respiratory disease management sector [16].

Core Viewpoint - Recent clinical research on Yuan Da Pharmaceutical's product Qino (Eucalyptol enteric-coated capsules) for chronic rhinosinusitis has been recognized by an international journal, marking a significant milestone in evidence-based medicine for the product [1][3]. Group 1: Clinical Research and Product Validation - The study, led by Professor Wang Dehui from Fudan University, involved over 300 patients across 13 major hospitals in China and demonstrated the safety and efficacy of Qino when used in conjunction with Budesonide nasal spray [4][5]. - Results indicated that the combination therapy significantly improved symptom scores and control rates compared to the control group, particularly in patients with a history of smoking [5][7]. - This research fills a gap in evidence for long-term combination therapy, supporting Qino's inclusion in standardized treatment pathways for chronic rhinosinusitis [7]. Group 2: Market Position and Growth Potential - Qino is a core product in Yuan Da Pharmaceutical's respiratory and critical care segment, recognized for its clinical significance and market leadership in cough and phlegm relief [4][10]. - The global respiratory drug market is projected to reach approximately $99.9 billion by 2024, with the Chinese market expected to grow from about $11.6 billion to $13.8 billion by 2028, at a compound annual growth rate of 4.5% [7]. - Yuan Da Pharmaceutical has a diverse product pipeline addressing various respiratory conditions, including asthma and chronic obstructive pulmonary disease, enhancing its competitive edge in the market [11][12]. Group 3: Future Development and Strategic Focus - The company emphasizes innovation and advanced technology in product development, aiming to create a comprehensive management product cluster for chronic respiratory diseases and critical care [16]. - Yuan Da Pharmaceutical's strategic focus on both domestic and international markets is expected to strengthen its industry position and drive valuation growth [15].

Core Viewpoint - YuanDa Pharmaceutical (00512) is deepening its strategy in urological diagnosis and treatment products, aiming to unlock a market potential worth billions through strategic investments in the urology field [1][3]. Group 1: Strategic Cooperation - The company has signed a cooperation agreement with Shanghai Yingte Weilu Medical Device Co., Ltd. to obtain global exclusive commercialization rights for the VTAS steam ablation product for treating benign prostatic hyperplasia (BPH) [1]. - This strategic cooperation aligns with YuanDa's dual focus on "products" and "technology," creating a new pattern of "channel expansion" and "innovation collaboration" [3]. - The partnership will accelerate market penetration post-product launch and enhance the research collaboration, solidifying YuanDa's global strategic layout in the urology diagnosis and treatment sector [3][12]. Group 2: Market Potential and Technology - BPH is a common urological condition among middle-aged and elderly men, with a prevalence rate of 60% in men over 60 and up to 90% in those aged 70-80, affecting over 100 million men in China [4]. - Traditional treatment methods include medication and invasive surgeries, which have limitations such as impact on sexual function and surgical risks [4][5]. - The steam ablation technology offers a minimally invasive solution, with advantages such as short operation time (under 10 minutes), low recurrence rates, and high safety, making it a promising alternative in the BPH treatment landscape [6][7]. Group 3: Product Features and Innovations - The VTAS steam ablation system is the only BPH steam ablation product in China with a core patent for steam generation and control, enhancing treatment efficacy and safety [6]. - VTAS features advanced energy control precision, stable steam output, and a unique puncture structure design ensuring 100% puncture success [6][7]. - The product is compatible with most bladder scopes and incorporates self-developed algorithms and AI-assisted functions for personalized treatment [7]. Group 4: Broader Product Ecosystem - YuanDa has developed a comprehensive product cluster in the urology field, covering various conditions including urinary tract cancer and prostate cancer, enhancing its market control [8]. - The company holds exclusive commercialization rights for several innovative products, including early detection tools for urinary tract cancer, which have received breakthrough device designation from the FDA [8][9]. - YuanDa's Go Global strategy aims to establish a global pharmaceutical brand, leveraging its full industry chain capabilities in the nuclear medicine and high-end medical device sectors [12].

Core Viewpoint - The company is deepening its strategic investment in urology treatment products, aiming to tap into a market potential worth billions through a partnership with Shanghai Yingtai Weilu Medical Device Co., Ltd. [1][3] Group 1: Strategic Partnership - The collaboration with Shanghai Yingtai Weilu Medical Device Co., Ltd. grants the company exclusive global commercialization rights for the VTAS steam ablation product, designed for treating benign prostatic hyperplasia (BPH) [1][3] - The partnership will establish a joint laboratory to enhance drug-device research and development, expanding the company's industrial ecosystem [1][3] Group 2: Market Potential and Treatment Landscape - BPH is a common urological condition among middle-aged and elderly men, with over 100 million men in China affected, and the prevalence increases with age [4][6] - Traditional treatment methods include medication and invasive surgeries, which have various drawbacks such as impact on sexual function and surgical risks [4][5] Group 3: Advantages of VTAS Technology - The VTAS steam ablation technology offers significant advantages, including a short operation time of under 10 minutes, minimal invasiveness, and a lower recurrence rate, making it a promising alternative to traditional treatments [6][7] - The product features unique technology with a patented steam generation and control method, ensuring high precision and stability in treatment [6][7] Group 4: Comprehensive Product Portfolio - The company has developed a diverse product portfolio in the urology field, covering various conditions including urinary tract cancer and prostate cancer, enhancing its market competitiveness [8][9] - The company holds exclusive commercialization rights for several innovative products, including early detection tools for urinary tract cancer, which have received breakthrough device designation from the FDA [9][10] Group 5: Global Expansion Strategy - The company is committed to a "Go Global" strategy, aiming to establish a global pharmaceutical brand by leveraging its comprehensive capabilities across the entire supply chain [10][13] - The establishment of a joint laboratory is expected to enhance the company's competitive edge in the urology product sector and drive long-term innovation [12][13]

Core Viewpoint - The Hong Kong International Biotechnology Forum and Exhibition (BIOHK) 2025 serves as a significant platform for industry leaders to discuss the future of biotechnology, with a focus on the global strategy of the pharmaceutical company YuanDa Pharmaceutical [1][3]. Group 1: Company Strategy and Globalization - YuanDa Pharmaceutical is recognized as a leading global player in nuclear medicine, sharing its global strategy at the BIOHK 2025 forum [3][6]. - The company is implementing a "Go Global" strategy, focusing on global research, production, and sales to enhance the value of innovative products [3][10]. - YuanDa has achieved significant milestones in its nuclear medicine development, with its product Yttrium-90 microsphere injection being used in over 150,000 patients across more than 50 countries [6][10]. Group 2: Product Development and Market Expansion - The company has received CE mark certification for new indications of its innovative product, expanding its treatment scope to include multiple types of liver cancer, which is expected to double its market potential [6][10]. - YuanDa is advancing its pipeline with 15 innovative products in development, covering various cancers and utilizing five types of radioactive isotopes [7][9]. - The company is actively pursuing a "dual filing" strategy in the U.S. and China, with several products entering international Phase III clinical trials [9][10]. Group 3: Research and Production Capabilities - YuanDa has established a comprehensive global network for nuclear medicine, with research and production bases in Boston and Chengdu, and a sales network covering over 50 countries [11][13]. - The company has built a state-of-the-art production facility in Chengdu, recognized as one of the most automated and comprehensive nuclear medicine factories globally [11][13]. - YuanDa's global innovation strategy includes five research platforms and eight research centers, with a robust pipeline of 133 projects in various stages of development [13].

Core Viewpoint - The Hong Kong International Biotechnology Forum and Exhibition (BIOHK) 2025 serves as a significant platform for industry leaders to discuss the future of biotechnology, with a focus on the global strategy of Yuan Da Pharmaceutical in nuclear medicine [1][3]. Group 1: Company Strategy - Yuan Da Pharmaceutical is recognized as a leading global nuclear medicine company, sharing its unique global development strategy at the forum [3][5]. - The company is implementing a "Go Global" strategy, focusing on global R&D, production, and sales to enhance the long-term value of innovative products [3][5][9]. Group 2: Market Expansion - The recognition of Chinese innovative drugs is increasing globally, with a notable rise in the number of oral presentations by Chinese pharmaceutical companies at the ASCO conference, from 25 in 2023 to 84 in 2025 [3]. - In the first half of 2025, the transaction value of innovative drug licensing exceeded the total for 2024, indicating strong innovation capabilities [3]. Group 3: Product Development - Yuan Da Pharmaceutical has achieved significant breakthroughs in nuclear medicine, with its innovative product, Yttrium-90 microsphere injection, being used in over 50 countries and for more than 150,000 patients [5]. - The product is the first and only FDA-approved treatment for unresectable hepatocellular carcinoma (HCC) and colorectal cancer liver metastases, recently receiving CE mark certification for additional indications [5]. Group 4: R&D Pipeline - The company has 15 innovative products in the R&D registration phase, utilizing five types of radioactive isotopes to target eight different cancers [6][8]. - Yuan Da is advancing its "dual filing" strategy in the U.S. and China, with several products entering international multi-center Phase III clinical trials [8]. Group 5: Global Infrastructure - Yuan Da Pharmaceutical has established a comprehensive global sales network covering over 50 countries, supported by R&D bases in Boston and Chengdu, and production facilities in multiple international locations [10][12]. - The company’s Chengdu facility is noted for being one of the most automated and comprehensive nuclear medicine production plants globally, ensuring high-quality product supply [10]. Group 6: Long-term Vision - The company aims to deepen its global market penetration and brand development through its ongoing "Go Global" strategy, addressing unmet medical needs worldwide [12].

Core Viewpoint - The approval of the Blue Whale TM intracranial aneurysm embolization support frame marks a significant advancement in treatment options for intracranial aneurysms in China, enhancing the company's position in the high-end medical device market [1] Group 1: Company Developments - The company has been deeply engaged in the high-end medical device sector for many years, focusing on "precision treatment" and has established a comprehensive layout around three main areas: pathway management, structural heart disease, and heart failure [1] - The company has over 30 products in its high-end medical device portfolio, with 23 products approved for market in China under the pathway management category and 1 product approved for structural heart disease [1] - The company is actively advancing clinical registration for other products in China, with plans for phased and tiered launches of innovative products to drive stable growth in this business segment [1] Group 2: Global Expansion - The company is also expanding its global footprint in the field of cardiovascular precision interventional diagnosis and treatment, having established technical collaborations with clinical centers or R&D platforms in multiple countries including the USA, Canada, Germany, Italy, and Switzerland [1] - The company has successfully built a comprehensive "passive + active" innovative device platform, which is expected to enhance its capabilities in the global market [1] - With the ongoing implementation of its "Go Global" strategy, the company aims to develop this segment into a leading global platform for cardiovascular precision interventional diagnosis and treatment, further enhancing its overall value [1]