Core Viewpoint - The approval of Ryaltris® nasal spray by the National Medical Products Administration of China marks a significant advancement for the company in the respiratory and critical care sector, providing a new treatment option for allergic rhinitis patients in China [1][3]. 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, as well as perennial allergic rhinitis in adults and children aged 12 and above [2][3]. - The product received FDA approval in January 2022 and has been successfully launched in multiple countries, including Australia, Russia, South Korea, the UK, and the EU, demonstrating strong sales performance and significant market potential [2][3]. - The clinical trial for Ryaltris® (GSP 301-308) involved 535 patients and showed that its efficacy ratings surpassed those of the single-agent control treatments, confirming its safety and pharmacokinetic characteristics [3]. 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 individuals, including around 130 million with moderate to severe persistent allergic rhinitis [4]. - Current treatment options in China primarily consist of single-agent formulations, indicating a pressing clinical need and a substantial market opportunity for combination therapies like Ryaltris® [4]. Group 3: Strategic Focus and Future Plans - The respiratory and critical care sector is a core strategic area for the company, with a comprehensive product portfolio addressing various respiratory conditions, including asthma and chronic obstructive pulmonary disease [5]. - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and expand its product pipeline through a global operational strategy [6].

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]

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 ...