Core Viewpoint - The approval of the new specification (20ml: 50mg) for the drug Treprostinil by the National Medical Products Administration enhances treatment options for pulmonary arterial hypertension (PAH) patients, providing more precise dosing for clinicians [1][4] Group 1: Product Approval and Market Position - The new specification of Treprostinil injection received its drug registration certificate on September 22, 2023, and is a key medication for treating PAH, being the only prostacyclin analog available for subcutaneous and intravenous administration in China [1] - Treprostinil has demonstrated a stable market performance with annual sales exceeding $100 million, achieving approximately $517 million in global sales in 2020 [2] - The sales of Treprostinil injection in Chinese public medical institutions saw a significant year-on-year increase of 186.89% in 2021 [2] Group 2: Strategic Partnerships and Future Prospects - In November 2024, the company entered into a strategic investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical, acquiring approximately 14.42% equity and exclusive commercialization rights for Treprostinil inhalation formulations in Greater China [3] - The agreement also includes global exclusive commercialization rights for Treprostinil injection (excluding UAE, Ireland, and Russia) and its raw materials, as well as for sapropterin tablets for treating phenylketonuria [3] - The global registration process for Treprostinil inhalation and sapropterin tablets is progressing smoothly [3] Group 3: Clinical Impact - The new 20ml: 50mg specification of Treprostinil injection will provide clinicians with greater flexibility in dosing adjustments, better meeting the individualized treatment needs of patients at different stages of the disease [4]

Group 1: Product Development and Regulatory Approvals - The company has received a drug registration certificate from the National Medical Products Administration of China for a new specification (20ml:50mg) of its product, Treprostinil injection, used for treating pulmonary arterial hypertension (PAH) [1] - The existing specification (20ml:20mg) was approved for market launch in March 2023, and both specifications are included in the medical insurance catalog, allowing for more precise treatment options for clinicians [1] - The company has reached an equity investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical Co., Ltd., which includes acquiring approximately 14.42% equity and exclusive commercialization rights for Treprostinil inhalation formulation in Greater China [2] Group 2: Market Potential and Epidemiology - PAH is a rare cardiovascular disease with an incidence rate of approximately 2.4 per million person-years and a prevalence of about 15 per million, leading to high mortality and disability rates [3] - The global PAH market is projected to reach approximately $8.06 billion in 2024, with a compound annual growth rate (CAGR) of 5.3%, and the Asia-Pacific region expected to grow at a CAGR of 13.3% [3] Group 3: Clinical Efficacy and Treatment Landscape - Treprostinil is a synthetic prostacyclin analog that promotes vasodilation and inhibits platelet aggregation, with clinical studies showing significant long-term efficacy and safety [4] - The one-year and four-year survival rates for patients on Treprostinil monotherapy are 88% and 70%, respectively, indicating a substantial improvement in patient prognosis [4] - The approval of Treprostinil injection has altered the market landscape by reducing the monopoly of single products in the domestic market, potentially lowering the medical burden on PAH patients [4] Group 4: Commitment to Rare Diseases and Innovation - The company is focused on developing treatments for rare diseases, with over 20 products in the pipeline, including those for conditions like N-acetylglutamate synthase deficiency and hyperammonemia [5] - The company aims to address the clinical needs in the rare disease sector, responding to government and societal calls, and is committed to increasing the development of effective treatments for rare diseases [5] - The company emphasizes innovation and advanced technology in product development, aiming to create a global sales network and enhance its international presence [6][7]

Core Viewpoint - The company has made significant progress in the treatment of pulmonary arterial hypertension (PAH) with the approval of a new specification for its drug, which will enhance treatment options for patients [1][4]. Group 1: Product Development and Approval - The company received a drug registration certificate from the National Medical Products Administration for a new specification (20ml: 50mg) of its drug for PAH treatment, complementing the previously approved 20ml: 20mg specification [1]. - The new specifications will allow clinicians to provide more precise treatment plans based on patient needs, marking a major advancement in the rare disease sector of cardiovascular emergency care [1]. - The company has also entered into an equity investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical, acquiring approximately 14.42% equity and exclusive commercialization rights for various formulations of its PAH treatment [2]. Group 2: Market Potential and Epidemiology - PAH is a rare cardiovascular disease with an incidence rate of approximately 2.4 per million person-years and a prevalence of about 15 per million, indicating a significant unmet medical need [3]. - The global PAH market is projected to reach approximately $8.06 billion in 2024, with a compound annual growth rate (CAGR) of 5.3%, and the Asia-Pacific region expected to grow at a CAGR of 13.3% [3]. Group 3: Clinical Efficacy and Treatment Landscape - The drug, a synthetic prostacyclin analog, has demonstrated long-term efficacy and safety in clinical studies, with survival rates of 88% and 70% at one and four years, respectively [4]. - The approval of the injection solution has altered the market dynamics, potentially reducing the financial burden on PAH patients [4]. Group 4: Commitment to Rare Diseases - The company is focused on developing treatments for rare diseases, with over 20 products in the pipeline, including those for conditions like N-acetylglutamate synthase deficiency and Cushing's disease [5]. - The company aims to address the significant challenges faced by rare disease patients, where only 5% of such diseases have effective treatments available [5]. Group 5: Innovation and Global Strategy - The company emphasizes innovation and advanced technology in product development, aiming to meet unmet clinical needs and enhance its product pipeline [6][7]. - A strategy of global operational layout and dual-circulation development is being adopted to promote domestic and international growth [6][7].

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 ...