TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first Apixaban oral dissolving film (ODF). The study confirmed that TAH3311 is bioequivalent to U.S. and European reference Apixaban tablets (Eliquis®) under fasting conditions, with Cmax and AUC values falling within the regulatory acceptance range (80-125%).

TAHO制药公司宣布了TAH3311关键研究的积极初步结果，这是全球首款阿哌沙班口服溶解膜（ODF）。研究表明，在空腹条件下，TAH3311与美国和欧洲的参考阿哌沙班片剂（Eliquis®）具有生物等效性，其Cmax和AUC值均在监管接受范围内（80-125%）。

The study enrolled 60 healthy volunteers with 48 completing the trial. These results meet the criteria previously discussed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a basis for filing a New Drug Application (NDA) and a Marketing Authorization Application (MAA), respectively, marking a significant milestone in the regulatory development..

该研究招募了60名健康志愿者，其中48人完成了试验。这些结果符合此前与美国食品药品监督管理局 (FDA) 和欧洲药品管理局 (EMA) 讨论的标准，分别作为提交新药申请 (NDA) 和上市许可申请 (MAA) 的依据，标志着监管开发方面的一个重要里程碑。

Globally, 15 million people suffer from strokes each year. Nearly half of hospitalized stroke patients experience swallowing difficulties, and approximately 13% develop long-term dysphagia. Conventional anticoagulants often require crushing tablets and mixing with liquids for patients with swallowing difficulties, which can lead to dosing inaccuracies and significant patient inconvenience.

全球每年有1500万人罹患中风，近半数住院中风患者存在吞咽困难，其中约13%的患者会发展为长期吞咽障碍。常规抗凝药物常需要压碎药片并混入液体给吞咽困难患者服用，这可能导致剂量不准和患者不便。

TAH3311 dissolves rapidly in the mouth without water, providing a more convenient alternative to tablets. Dr. Howard Lee, Chairman and CEO of TAHO Pharmaceuticals, stated, 'This pivotal study underscores our commitment to patient-centric innovation. TAH3311 is especially valuable for stroke patients, the elderly, children or others who have swallowing difficulties and require anticoagulant therapy twice daily.

TAH3311在口腔中无需水即可快速溶解，为片剂提供了更便捷的替代方案。TAHO制药公司董事长兼首席执行官李霍华德博士表示：“这项关键研究强调了我们以患者为中心的创新承诺。TAH3311对中风患者、老年人、儿童或有吞咽困难且需要每日两次抗凝治疗的其他人群尤其有价值。

We believe this novel formulation can improve patient outcomes and reduce the risk of aspiration pneumonia caused by choking when swallowing medication with water.'.

我们相信，这种新型配方可以改善患者的治疗效果，并降低因吞咽药物时呛水而导致的吸入性肺炎的风险。

U.S. Apixaban sales reached $26.1 billion in 2024*, and the global anticoagulant market continues to expand. Given these trends, TAH3311 is well positioned as a safer and more accessible treatment option. TAHO Pharmaceuticals plans to file regulatory submissions in both the United States and Europe in Q3 2025.

美国阿哌沙班（Apixaban）的销售额在2024年达到261亿美元*，全球抗凝剂市场持续扩大。鉴于这些趋势，TAH3311作为一种更安全且更易获取的治疗选择，具备良好的市场定位。TAHO制药计划于2025年第三季度在美国和欧洲提交监管申请。

At the same time, the company is actively pursuing strategic collaboration opportunities with international partners to accelerate TAH3311's global launch..

同时，该公司正在积极寻求与国际伙伴的战略合作机会，以加速TAH3311的全球上市。

*Source: IQVIA 2024

*来源：IQVIA 2024

About Apixaban

关于阿哌沙班

Apixaban (co-developed by BMS and Pfizer under the brand name Eliquis®) is a direct factor Xa inhibitor and has been approved for clinical use in several thromboembolic disorders, including stroke prevention in non-valvular atrial fibrillation, thromboprophylaxis after hip/knee replacement, and the treatment and prevention of deep vein thrombosis or pulmonary embolism.

阿哌沙班（由百时美施贵宝和辉瑞共同开发，商品名为艾乐妥®）是一种直接Xa因子抑制剂，已被批准用于多种血栓栓塞性疾病的临床治疗，包括非瓣膜性心房颤动患者的卒中预防、髋/膝关节置换术后的血栓预防，以及深静脉血栓或肺栓塞的治疗和预防。

With notable safety advantages, it is the leading novel oral anticoagulant (NOAC)..

具有显著的安全性优势，是领先的新型口服抗凝药（NOAC）。

About TAHO Pharmaceuticals Ltd.

关于塔霍制药有限公司

Founded in 2010, TAHO Pharmaceuticals Ltd. leverages its proprietary Transepithelial Delivery System (TDS) to overcome the limitations of existing drugs and develop innovative dosage forms for niche markets. The TDS platform combines advanced transdermal and transmucosal delivery technologies, enabling the development of unique dosage forms such as transdermal patches, ODF, and buccal films.

成立于2010年的TAHO制药有限公司利用其专有的跨上皮递送系统（TDS）克服现有药物的局限性，为利基市场开发创新的剂型。TDS平台结合了先进的透皮和跨黏膜递送技术，能够开发独特的剂型，如透皮贴剂、ODF和颊膜。

TAHO's diverse product portfolio spans a variety of therapeutic areas, including antithrombotic agents, opioid overdose antidotes, addiction treatments, pediatric ADHD, and chemotherapy-induced antiemetics. Among its notable achievements, TAH4411, an ODF for chemotherapy-induced nausea and vomiting, became the first product of its kind to receive regulatory approval and be commercialized in Japan..

TAHO多样化的产品组合横跨多个治疗领域，包括抗血栓药物、阿片类药物过量解毒剂、成瘾治疗、儿童多动症（ADHD）以及化疗引起的止吐药。其中，值得一提的是，用于化疗引起的恶心和呕吐的ODF产品TAH4411成为了日本首个获得监管批准并商业化的此类产品。

Media Contact:

媒体联系人：

TAHO Pharmaceuticals

塔霍制药

Website: https://www.tahopharma.com/en/

网站: https://www.tahopharma.com/en/

+886-2-2659-8515

+886-2-2659-8515

ir@tahopharma.com

ir@tahopharma.com

Source: prnewswire.com

来源：prnewswire.com