中证报中证网讯(王珞)远大医药9月23日晚公告称，公司用于治疗肺动脉高压(PAH)的产品曲前列尼尔注 射液的新规格(20ml:50mg)，近日获得国家药监局颁发的药品注册证书，该产品20ml:20mg的规格已于 2023年3月获批上市，两种规格将有助于临床医生根据患者的情况提供更加精准的治疗方案。 曲前列尼尔是一种人工合成的前列环素类似物，可以促进血管舒张，同时抑制血小板聚集，进而治疗 PAH的症状。曲前列尼尔注射液已是临床上治疗PAH的一线用药以及靶向药物联合治疗方案中的基础用 药。 心脑血管急救板块是远大医药制药科技领域重点布局的方向之一，作为"国家基本用药生产基地""国家 战备储备急救用药生产企业""国家小品种药(短缺药)集中生产基地建设单位"，目前公司在心脑血管急救 板块拥有近30个品种，其中，14个品种纳入了国家急抢救药品目录，16个品种纳入了短缺药品目录，产 品管线数量位居行业前列。 目前，远大医药心脑血管急救板块在研产品超过20款，其中，罕见病方面，除了此次曲前列尼尔注射液 新规格获批上市外，用于治疗成人或儿童由N-乙酰谷氨酸合成酶(NAGS)缺乏症、异戊酸血症(IVA)、甲 基丙二酸血症(MM ...

Core Viewpoint - The introduction of a new specification for the first-line treatment of pulmonary arterial hypertension (PAH) in China will provide rare disease patients with more clinical medication options [1][2]. Group 1: Product Development and Market Potential - The new specification of 20ml:50mg for the drug Treprostinil injection has been approved by the National Medical Products Administration, complementing the existing 20ml:20mg specification approved in March 2023 [1][7]. - 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% [5]. - Treprostinil, a synthetic prostacyclin analog, has shown significant efficacy and safety in clinical studies, with one-year and four-year survival rates of 88% and 70% respectively [5][6]. Group 2: Company Strategy and Collaborations - The company has entered into a strategic investment and product cooperation agreement with Shanghai Zhongqiang Pharmaceutical, acquiring exclusive commercialization rights for Treprostinil inhalation formulations and injection globally, excluding certain regions [7]. - The company is expanding its product matrix to address unmet clinical needs, focusing on both common and rare diseases, thereby enhancing its market position in the cardiovascular emergency sector [8][9]. Group 3: Clinical and Epidemiological Insights - PAH is characterized by high pulmonary vascular resistance and pressure, leading to severe symptoms and a poor prognosis, with a median survival of only 2.8 years in the absence of targeted therapies [2]. - The incidence of adult PAH is approximately 2.4 per million person-years, with a prevalence of about 15 per million, indicating a significant clinical need for effective treatments [2].

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]

智通财经APP讯，远大医药(00512)发布公告，本集团用于治疗肺动脉高压(pulmonary arterial hypertension，"PAH"，WHO 分类 1)的产品曲前列尼尔注射液的新规格(20ml : 50mg)，近日获得中国国 家药品监督管理局(中国药监局)颁发药品注册证书，本产品 20ml:20mg 的规格已于2023年3月获批上 市。本产品为医保目录产品，两种规格将有助于临床医生根据患者的情况提供更加精准的治疗方案，这 是本集团在心脑血管急救领域罕见病方向的重大进展。 心脑血管急救板块是本集团制药科技领域重点布局的方向之一，作为"国家基本用药生产基地"、"国家 战备储备急救用药生产企业"、"国家小品种药(短缺药)集中生产基地建设单位"，本集团心脑血管急救板 块拥有近 30 个品种，其中 14 个品种纳入了国家急抢救药品目录，16 个品种纳入了短缺药品目录，产 品管线数量位居行业前列。目前心脑血管急救板块在研产品超过 20 款，其中罕见病方面，除了此次曲 前列尼尔注射液新规格获批上市外，用于治疗成人或儿童由 N-乙酰谷氨酸合成酶(NAGS)缺乏症、异戊 酸血症(IVA)、甲基丙二酸血症(MM ...