来源：环球网 据远大医药公告，公司曲前列尼尔注射液的新规格（20ml：50mg）已于9月22日获国家药监局颁发药品 注册证书。据悉，曲前列尼尔注射液是医保目录产品，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，且是国内唯一可用于治疗PAH的皮下和静脉给药前列环素类药物。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。 图片来源：《The evolution of survival of pulmonary arterial hypertension over 15 years》 对患者而言，一旦确诊PAH则需终生服药，这也意味着该疾病存在着巨大的市场需求。第三方研究显 示，2024年全球PAH市场规模约为80.6亿美元，其中前列环素类市场份额占比达45%，预计到2034年全 球PAH市场规模将达约135亿美元，年复合增长率达到5.3%，其中亚太地区的年复合增长率预计可达 13.3%，市场前景巨大。 肺动脉高压是一种罕见的心血管疾病，由多种异源性疾病（病因）和不同发病机制所致肺血管结构或功 能改变，引起肺血管阻力和 ...

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 ...

国家医疗保障局开展真实世界医保综合价值评价试点工作 这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 9月23日，国家医疗保障局办公室发布《关于开展真实世界医保综合价值评价试点工作的通知》。通知 提出，试点先行地区要在国家医保局统一部署下，按照"顶层设计、实践验证、决策应用"的工作思路， 通过在评价规范标准、技术方法、应用场景的实践探索以及相关数据、人才支撑体系拓展建设，到2027 年底，推进十个选题的研究落地，形成一套以价值为导向、基于真实世界研究的医保综合价值评价体 系，并在全国范围推广。 21点评：这是一场涉及理念、技术和制度的系统性变革。通过构建科学的评价体系、优化数据治理、深 化三医联动等，试点将推动医保从"被动支付"向"主动购买价值"转型，提高医保基金使用效率，赋能医 药行业高质量发展。 药械审批 恒瑞医药：阿得贝利单抗注射液新适应症上市许可申请获国家药监局受理 9月23日，恒瑞医药(600276.SH)公告称，公司子公司上海盛迪医药有限公司收到国家药监局下发的《受 理通知书》，公司阿得贝利单抗注射液新适应症的药品上市许可申请获国家药监局受理。 ...

Major Developments - Weimob Group (02013) has established Weimob Overseas and become the exclusive strategic partner of Genstore.ai in China [1] - Postal Savings Bank of China (01658) plans to absorb and merge its wholly-owned subsidiary Postal Huijia Bank [1] - Xixiang Group (02473) has reached a strategic cooperation intention with Smart Donkey to jointly create high-value urban delivery solutions [1] - Jiufang Zhitu Holdings (09636) has subscribed to shares of EXIO Group Limited to accelerate the layout and market expansion of overseas digital asset business [1] - Fubo Group (03738) plans to issue zero-coupon convertible bonds worth HKD 1.6 billion due in 2026 to enhance AIGC and RWA business [1] - Tencent Holdings (00700) has completed the issuance of HKD 9 billion notes [1] - Yuan Da Pharmaceutical (00512) has received a drug registration certificate for Quqianlian Injection (20ml: 50mg) [1] - Cathay Pacific Airways (00293) reported a 28% year-on-year increase in passenger volume for the first eight months [1] Buybacks and Shareholding Changes - Tencent Holdings (00700) repurchased 867,000 shares for HKD 550 million on September 23 [1] - Midea Group (00300) repurchased 2.72 million A-shares for HKD 200 million on September 23 [1] - Anta Sports (02020) repurchased 2.12 million shares for HKD 200 million on September 23 [1] - SF Holding (06936) spent approximately HKD 80.8 million to repurchase 202,000 A-shares on September 23 [1] - Wanka Yilian (01762) saw major shareholders Gao Dinan and Jiang Yu each increase their holdings by 200,000 shares [1] - China Software International (00354) received an increase of 1.5 million shares from major shareholder Chen Yuhong [1] - Zhejiang Shibao (01057) saw its controlling shareholder Shibao Holdings reduce its stake in the company by 1.5% [1]

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]

Core Viewpoint - The announcement highlights the approval of a new specification for the drug Treprostinil Injection by the National Medical Products Administration, indicating a significant development for the company and its product line in the treatment of pulmonary arterial hypertension (PAH) [1] Group 1: Product Approval - The new specification of Treprostinil Injection (20ml:50mg) received its drug registration certificate on September 22 [1] - The existing specification (20ml:20mg) was approved for market launch in March 2023 [1] Group 2: Market Position - Treprostinil Injection is listed in the medical insurance catalog and serves as a first-line treatment for PAH [1] - It is the only drug in China that can be administered subcutaneously and intravenously for the treatment of PAH, positioning the company uniquely in the market [1]

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].

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。多项临床研究已经证实曲前列尼尔长期应用的有效性和安全性，单药治疗1年和4年的生存 率分别是88%和70%，患者预后得到显着改善。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，且是国内唯一可用于治疗PAH的皮下和静脉给药前列环素类药 物。集团曲前列尼尔注射液的获批上市，成功改变了该产品国内市场单品垄断的市场格局，有望进一步 降低PAH患者的医疗负担。 格隆汇9月23日丨远大医药(00512.HK)公告，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)，近日获得中华人民共和国国家 药品监督管理局颁发药品注册证书，产品20ml:20mg的规格已于2023年3月获批上市。产品为医保目录 产品，两种规格将有助临床医生根据患者的情况提供更加精准的治疗方案，这是集团在心脑血管急救领 域罕见病方向的重大进展。 ...

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 ...