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，本集團引進的用於治療蠕形蟎瞼緣炎的全球創新眼科藥物 GPN01768 [TP-03，(洛替拉納滴眼液) 0.25%]近日正式獲得中華人民共和國國家藥品監督管理局 (「藥監局」)頒發的藥品註冊證書，且在藥品審評過程中未收到補充資料通知，實現「零 發補」獲批上市。本集團於二零二四年三月與 Tarsus Pharmaceuticals, Inc. (「Tarsus Pharmaceuticals」，TP-03 的開發者)達成產品引進戰略合作協議，獲得在大中華區（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）的獨家開發、生 產及商業化權益。此次該產品獲批上市是本集團在五官科板塊眼科創新藥方向上的又一 項重要進展。 蠕形蟎是導致蠕形蟎瞼緣炎的根本原因，GPN01768 是一 ...

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 Viewpoint - The approval of Ryaltris® by the National Medical Products Administration marks a significant milestone for the company, introducing a new combination nasal spray for allergic rhinitis in China, which is expected to meet the clinical needs of a large patient population and reshape the market landscape dominated by foreign products [1][4][10] Market Opportunity - Allergic rhinitis is a chronic condition affecting approximately 10% to 20% of the global population, with China having a prevalence rate of about 17.6%, translating to nearly 250 million affected individuals [1][4] - The market for allergic rhinitis medications in China is projected to grow from 43.275 billion RMB in 2024 to 50.090 billion RMB in 2028, with a compound annual growth rate of approximately 3.72% [4] Product Details - Ryaltris® is a novel combination nasal spray that provides symptomatic relief for moderate to severe seasonal allergic rhinitis in adults and children aged 6 and above, and for perennial allergic rhinitis in adults and children aged 12 and above [5] - Clinical data from Phase III trials indicate that Ryaltris® outperformed two existing single-agent nasal sprays, demonstrating superior efficacy and safety [5] Competitive Landscape - Prior to Ryaltris®'s approval, the Chinese market primarily featured single-agent formulations, predominantly from foreign companies, with no approved combination nasal sprays [4][5] - The introduction of Ryaltris® is expected to fill a significant clinical gap and challenge the current market dominance of foreign products [4][5] Company Strategy - The company has a diversified pipeline in the respiratory and critical care sectors, including multiple high-potential products aimed at addressing various respiratory conditions [6][7] - The company plans to continue its focus on innovation and global expansion, aiming to develop a comprehensive product portfolio for chronic airway diseases and critical care [10]

Core Insights - The approval of Ryaltris® (GSP 301 NS) by the National Medical Products Administration marks a significant advancement in the treatment of allergic rhinitis in China, introducing a new combination therapy for patients [1][6] - The market for allergic rhinitis treatments in China is projected to grow significantly, with an estimated increase from 43.275 billion RMB in 2024 to 50.09 billion RMB by 2028, reflecting a compound annual growth rate of approximately 3.72% [5] - Ryaltris® is the first innovative combination nasal spray for allergic rhinitis in China, addressing a clinical need and potentially altering the current market landscape dominated by foreign products [6][7] Market Demand and Patient Demographics - Allergic rhinitis is a chronic condition affecting a large population, with approximately 17.6% of adults in China suffering from it, translating to nearly 250 million individuals, including 130 million with moderate to severe persistent symptoms [2][5] - The prevalence of allergic rhinitis in China is expected to rise, with projections indicating nearly 270 million patients by 2033 [2] Product and Clinical Efficacy - Ryaltris® combines an antihistamine and a corticosteroid, providing a more effective treatment option for moderate to severe seasonal and perennial allergic rhinitis, which has shown superior efficacy compared to existing single-agent treatments [6][8] - Clinical data from Phase III trials indicate that Ryaltris® outperformed two existing single-agent nasal sprays, demonstrating its potential for better patient outcomes [6] Company Strategy and Product Pipeline - The company has a diverse product pipeline in the respiratory and critical care sectors, including multiple high-potential products aimed at addressing various respiratory conditions [8][11] - The successful launch of Ryaltris® is expected to enhance the company's market position in the allergic rhinitis segment and contribute to overall revenue growth [7][8] - The company is committed to ongoing innovation and development of new therapies, with a focus on unmet clinical needs in respiratory diseases [11]

Core Viewpoint - The approval of Ryaltris (GSP301NS) by the National Medical Products Administration marks a significant milestone for the company, introducing a new treatment option for allergic rhinitis in China and leading the way into a new era of combination therapies in the market [1][11]. Market Opportunity - Allergic rhinitis is a chronic condition affecting approximately 10% to 20% of the global population, with China having a notably high prevalence rate of about 17.6%, translating to nearly 250 million affected individuals [2][5]. - The market for allergic rhinitis medications in China is projected to grow from 43.275 billion RMB in 2024 to 50.090 billion RMB in 2028, with a compound annual growth rate (CAGR) of approximately 3.72% [5]. Product Details - Ryaltris is a novel combination nasal spray that combines an antihistamine and a corticosteroid, designed for the symptomatic treatment of moderate to severe seasonal allergic rhinitis in adults and children aged 6 and above, as well as perennial allergic rhinitis in adults and children aged 12 and above [6]. - Clinical data from Phase III trials indicate that Ryaltris outperformed two existing single-agent nasal sprays, demonstrating superior efficacy and safety profiles [6]. Competitive Landscape - The approval of Ryaltris fills a significant gap in the Chinese market, which has been dominated by foreign single-agent nasal sprays, and is expected to enhance the treatment options available for patients suffering from allergic rhinitis [5][6]. - The company has also developed multiple high-potential products in the allergic rhinitis space, including two first-generic products that have already been launched, indicating a strong pipeline and market presence [7]. Strategic Focus - The respiratory and critical care segment is a core strategic area for the company, which has established a comprehensive product portfolio addressing various respiratory conditions [8]. - The company aims to continue its focus on innovation and global expansion, developing a range of products for chronic airway diseases and critical care, thereby solidifying its position in the industry [11].

Core Viewpoint - Huaxi Securities has initiated coverage on Yuan Da Pharmaceutical, highlighting significant upside potential in the company's valuation due to its robust barriers in the nuclear medicine sector and the rollout of innovative drugs [1] Group 1: Financial Projections - The company is projected to achieve total revenues of HKD 12.27 billion, HKD 13.46 billion, and HKD 14.70 billion for the years 2025, 2026, and 2027 respectively [1] - Corresponding net profits for the parent company are expected to be HKD 2.01 billion, HKD 2.25 billion, and HKD 2.56 billion for the same years, with EPS estimates of HKD 0.57, HKD 0.63, and HKD 0.72 [1] Group 2: Product Development and Market Potential - The company has successfully completed Phase II clinical trials for its globally first drug STC3141, showing significant improvement in SOFA scores in the high-dose group compared to the baseline [1] - STC3141 targets the core of immune dysregulation in sepsis through an innovative mechanism, potentially filling a 40-year gap in targeted drug options and opening a market worth over HKD 10 billion [1] - The company is advised to monitor the subsequent Phase III clinical data and global registration plans for STC3141 [1] Group 3: Business Stability and Growth - The company maintains a solid foundation with over 260 medical insurance products, with core respiratory products like Cheno expected to drive nearly 27% growth in 2024 [2] - The revenue share from innovative and barrier products has rapidly increased to 51% in the first half of 2025, up from 36.1% in the same period last year, indicating significant transformation [2] - The company is positioned for a value reassessment cycle, supported by the growth of nuclear medicine, the launch of innovative drugs, and stable traditional business [2]

Core Viewpoint - Huaxi Securities has initiated coverage on Yuan Da Pharmaceutical (00512) with an "Accumulate" rating, highlighting significant upside potential in the company's valuation due to its robust barriers in the nuclear medicine sector and the rollout of innovative drugs [1] Group 1: Financial Projections - The company is projected to achieve total revenues of HKD 12.27 billion, HKD 13.46 billion, and HKD 14.70 billion for the years 2025, 2026, and 2027 respectively [1] - Corresponding net profits for the parent company are expected to be HKD 2.01 billion, HKD 2.25 billion, and HKD 2.56 billion for the same years, with EPS estimates of HKD 0.57, HKD 0.63, and HKD 0.72 [1] Group 2: Product Development and Market Potential - The company has successfully completed Phase II clinical trials for its globally pioneering drug STC3141, showing significant improvement in SOFA scores in the high-dose group compared to the baseline, with a p-value of less than 0.05 [1] - STC3141 targets the core of immune dysregulation in sepsis through an innovative mechanism, potentially filling a 40-year gap in targeted drug therapies, and is expected to open a market worth over HKD 10 billion [1] - The company has a solid foundation with over 260 medical insurance products, and core respiratory products like Cheno are projected to drive nearly 27% growth in 2024 [2] Group 3: Business Transformation and Growth - The revenue share from innovative and barrier products has rapidly increased to 51% in the first half of 2025, up from 36.1% in the same period last year, indicating significant transformation [2] - Star products such as Yigan Tai®, Enzhuo Run®/Enming Run® (asthma inhalation preparations), LavaTM, and Nengqilang® are accelerating in market release, creating a favorable dynamic of stable growth in traditional business and explosive growth in innovative business [2] - The company is expected to enter a value reassessment cycle as nuclear medicine expands, innovative drugs are launched, and traditional business remains stable [2]

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].