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 - 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]