Propofol

STOCKHOLM, April 25, 2024 /PRNewswire/ -- Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 1 phase III clinical trial in the United States. Concurrently, the identical INSPiRE-ICU 2 trial is nearing completion, with 23 of 235 randomized patients remaining. The company anticipates topline results from both trials in the second half of 2024, with a planned New Drug Application (NDA) submission in the first quarter of 2025. "The completion of the INSPiRE-ICU 1 study marks a true milestone for Sedana Medical. Launching the randomized controlled multicenter studies across the large and diverse US healthcare landscape, in mixed surgical and medical ICUs with a different staffing and workflow compared to Europe, has been exciting. There is a lot of enthusiasm and interest in using inhaled sedation in US practice, which we hope will be possible soon", said Peter Sackey, Chief Medical Officer of Sedana Medical. Peter Sackey further elaborated: "Once the 30-day follow-up of all patients is complete, we will enter into an intense phase of final monitoring, data cleaning and transfer to our statistician team for analysis. In parallel, the long-term outcomes at 3 and 6 months will be collected centrally by the Critical Illness, Brain Dysfunction, and Survivorship team at Vanderbilt Medical Center. With this parallel approach, we expect topline results in the autumn of this year and a swift regulatory submission in Q1, 2025". "Working on these trials from initial design to implementation and completion has been very rewarding and has brought together many experienced clinical researchers in critical care across the US. We, and the clinicians at the bedside, are eager to see inhaled sedation available also in the US", said Christopher Hughes, Professor of Anesthesiology at Vanderbilt University Medical Center and Senior Lead Investigator for the INSPiRE-ICU 1 study. Johannes Doll, President and CEO of Sedana Medical, expressed gratitude, stating: "I would like to sincerely thank all our clinical trial sites, partners, and the Sedana Medical team for this significant achievement. It makes me very proud that we have been able to convene this exceptional group of intensive care teams from some of the most prominent US hospitals. Their advice and support will be invaluable as we work towards making the benefits of inhaled sedation accessible to patients in the United States." INSPiRE-ICU 1 and 2 are two identical randomized phase III trials, aiming to confirm the efficacy and safety for sedation with isoflurane delivered via Sedana Medical's unique medical device Sedaconda ACD. The primary endpoint is the proportion of time spent at adequate depth of sedation, compared with intravenous sedation using propofol. In addition, several important secondary endpoints are being studied, including opioid use, time to wake-up, cognitive recovery and spontaneous breathing. The first patient was included in April 2022, and 31 highly reputed clinics in the United States are involved in the two trials. The design of the US studies is similar to the Sedaconda study (SED001) successfully performed in Europe in 2017–2019, which resulted in market approval in 2021. For additional information, please contact: Johannes Doll, CEO, +46 (0)76 303 66 66 Johan Spetz, CFO, +46 (0)730 36 37 89 [email protected] About Sedana Medical Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient's life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care. Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors. Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden. This information was brought to you by Cision The following files are available for download:

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。2024年4月23日，据NMPA官网公示，石家庄四药的4类仿制药利奈唑胺干混悬剂获批上市并视同过评。此前，国内市场上利奈唑胺干混悬剂仅有辉瑞的原研药获批进口，此次石四药获批，成功拿下国内首仿。截图来源：NMPA官网利奈唑胺是辉瑞子公司Pharmacia研发的恶唑烷酮类抗菌药（商品名为 Zyvox），主要用于治疗革兰氏阳性菌引起的感染。利奈唑胺是第一个恶唑烷酮类抗生素。于2000年经美国 FDA 批准上市。2014 年第二代恶唑烷酮类抗生素磷酸特地唑胺问世（商品名 Sivextro）。相较于第一代恶唑烷酮类抗生素利奈唑胺，磷酸特地唑胺对耐受甲氧西林的革兰阳性菌的抑制作用要高 4～16 倍，安全性在一定程度上也有所提高。 销售峰值超17亿元，石四药斩获新剂型首仿 此前国内生产的利奈唑胺仅利奈唑胺片和利奈唑胺葡萄糖注射液2种剂型。据药融云数据统计，在全国院内销售市场上，这2个品种峰值销售总额超17亿元，其抗菌谱广泛，市场应用前景乐观。截图来源：药融云全国医院销售数据库在院内市场，利奈唑胺葡萄糖注射液凭借其独特的疗效和广泛的应用领域，占据了高达81.66%的市场份额，稳坐市场领头羊的地位。与此同时，利奈唑胺片也凭借其便捷的使用方式和良好的治疗效果，在市场中分得了一杯羹，占据了18.34%的市场份额。两者共同构成了利奈唑胺在院内市场的完整版图，展现了其强大的市场影响力和竞争力。截图来源：药融云全国医院销售数据库-全局分析目前，利奈唑胺在国内获批生产的有三种剂型，包括注射剂、片剂和干混悬剂。其中，对于利奈唑胺干混悬剂，石家庄四药集团是较早开发和率先获批的药企。此前国内市场上利奈唑胺干混悬剂仅有辉瑞的原研药获批进口，此次石四药获批，成功拿下国内首仿。截图来源：药融云中国药品批文数据库 14款品种重磅获批，1类新药直击2大千亿市场 近年来，石四药以市场需求为导向，坚持仿创结合的模式，持续加大研发强度，不断完善产品梯度开发体系。据财报显示，石药集团2023年实现营收314.5亿元，同比增长1.7%；实现净利58.7亿元，同比减少3.6%。石四药在仿制药领域的表现卓越，2024年至今，已成功过评包括盐酸利多卡因注射液、硫酸镁注射液、丙泊酚中/长链脂肪乳注射液、头孢呋辛酯干混悬剂等在内的14个品种，其中有2款干混悬剂，利奈唑胺干混悬剂是今年首家过评品种，也是国内首个获批的品种。截图来源：药融云过评药品汇总数据库在创新药方面，石四药有2款1类新药申请并获批临床。NP-01片拟用于治疗胃癌、肺癌、肝癌等晚期实体瘤，全球尚无同靶点药物获批上市。值得一提的是，NP-01是石四药集团首个获批临床的创新药。SYN045是一种选择性长效PGI2受体激动剂，拟用于肺动脉高压。据了解，临床前研究表明，SYN045具有良好的靶点选择性、化合物活性、安全性。SYN045研发取得积极进展，为临床罕见疾病患者治疗带来了希望和福音，同时进一步彰显了该集团创新药物研发步入发展快车道。截图来源：药融云中国药品审评数据库据药融云数据统计，在全国院内市场抗肿瘤药和免疫机能调节药物、心脑血管与血液系统药物（含中药）的销售峰值均超1300亿元。END本文为原创文章，转载请留言获取授权 点击阅读原文，申请药融云企业版免费试用！