Core Viewpoint - The company, Far East Pharmaceutical (00512.HK), has received a drug registration certificate from the National Medical Products Administration for its innovative global drug Ryaltris, a compound nasal spray for treating allergic rhinitis in adults and children, achieving approval without any supplementary information requests during the review process [1] Group 1 - The drug Ryaltris is specifically indicated for the treatment of allergic rhinitis (AR) in both adults and children [1] - The approval process for Ryaltris was completed without any requests for additional documentation, indicating a smooth regulatory review [1] - The receipt of the drug registration certificate marks a significant milestone for the company in its product development and market entry strategy [1]

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 - The approval of Ryaltris (GSP301NS) by the National Medical Products Administration (NMPA) marks a significant milestone for the company in the respiratory and critical care sector, providing a new treatment option for allergic rhinitis in China [1][2] Group 1: Product Development and Approval - Ryaltris is a novel combination nasal spray that combines an antihistamine and a corticosteroid, approved for treating moderate to severe seasonal allergic rhinitis in adults and children aged 6 and above [1] - The product received FDA approval in January 2022 and has been successfully launched in multiple countries, demonstrating strong sales performance and market potential [1] - The Phase III clinical trial (GSP301-308) involved 535 patients and showed that Ryaltris outperformed single-agent controls in efficacy, safety, and pharmacokinetics [2] Group 2: Market Opportunity - China has one of the highest prevalence rates of allergic rhinitis globally, with approximately 17.6% of adults affected, translating to nearly 250 million people, including around 130 million with moderate to severe persistent allergic rhinitis [3] - Current treatment options in China primarily consist of single-agent formulations, indicating a significant unmet clinical need and a vast market opportunity for combination therapies like Ryaltris [3] Group 3: Strategic Focus - The respiratory and critical care sector is a core strategic area for the company, with a comprehensive product portfolio addressing various respiratory conditions [4] - The company is committed to innovation and has several products in development targeting unmet clinical needs, including sepsis and acute respiratory distress syndrome [4] - The company aims to enhance its product pipeline and industry position through a combination of independent research and global expansion strategies [5]

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 Viewpoint - Yuan Da Pharmaceutical has received a drug registration certificate from the National Medical Products Administration of China for Ryaltris® nasal spray, marking a significant advancement in its respiratory and critical care research [1] Group 1: Product Development - Ryaltris® is a novel combination nasal spray that includes an antihistamine and a corticosteroid, designed for the symptomatic treatment of moderate to severe allergic rhinitis in adults and children aged 6 and above [1] - The product has achieved a "zero supplementary information" approval process, indicating a streamlined regulatory pathway [1] Group 2: Market Potential - Ryaltris® has already been approved by the FDA in January 2022 and has seen strong sales performance in various countries including Australia, Russia, South Korea, the UK, and the EU, highlighting its significant market potential [1] - The product aims to improve patient compliance by providing a more convenient and effective treatment option for allergic rhinitis patients in China [1] Group 3: Strategic Partnerships - The company entered into an exclusive licensing agreement with Glenmark in February 2019, securing the exclusive commercialization rights for Ryaltris® in China [1]

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 全球創新產品萊特靈®(Ryaltris®)複方鼻噴劑在中國獲批上市 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，由 Glenmark Specialty S.A. (「Glenmark」)研發的全球創新藥 Ryaltris® 複方鼻噴劑(「GSP 301 NS」或「萊特靈® 」)近日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，用於治療成人和兒童的過敏性鼻炎(「AR」)， 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，這是本集團在呼 吸及危重症領域的又一項重大研發進展。本集團於二零一九年二月與 Glenmark 訂立了 ...

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10月31日 狀態: 新提交 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: 2025年11月3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 | 本月底法定/註冊股本總額： HK ...