Phytonadione

MUNICH--( BUSINESS WIRE )--Daiichi Sankyo Europe, (hereafter, Daiichi Sankyo) today announced its reinforced commitment to addressing key unmet needs and barriers in cardiovascular (CV) care, by shining a light on inequalities in treatment and outcomes experienced by various patient groups. The announcement follows the presentation of data from sub-analyses of the SANTORINI observational study and ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) study programme, at the European Society of Cardiology (ESC) Congress 2024. Gender inequalities in CV disease treatment and LDL-C goal attainment Raised low-density lipoprotein cholesterol (LDL-C) is a key modifiable contributor to risk of cardiovascular major events. It has been shown that for every 1 mmol/L reduction in LDL-C, there is a 22% reduction in major cardiovascular events after 1 year. 7,8 Female patients in Europe who are at high or very high CV risk were undertreated and less achieved guideline-recommended LDL-C levels, according to data from the observational SANTORINI study. 1 As part of its efforts to expand medical knowledge to help protect people from CV disease (CVD), Daiichi Sankyo funds and designs studies, such as SANTORINI, that investigate the underlying causes behind the burden of CVD in Europe. Data from a new sub-analysis of SANTORINI, based on 5,197 male patients with a mean age of 65 years, and 2,013 females with a mean age of 66 years, showed that female patients were undertreated compared to men as fewer achieved guideline-recommended LDL-C levels within the study. 1 While the proportion of patients reaching LDL-C goals improved from baseline to 1-year follow up, it was greater in males (22.9% and 33.3%, respectively) than in females (16.9% and 24.6%,). 1 Despite similar guideline recommendations, more females received no lipid-lowering therapies at baseline and 1-year follow up (23.9% to 3.9%, respectively) than males (20.7% to 2.7%). 1 “We know that the severity of cardiovascular disease for women is as high as it is with men, and patients of both sexes remain undertreated. 9,10 But this new sub-analysis of the SANTORINI study further suggests that in clinical practice, women as a group were being disproportionally undertreated and do not always reach recommended LDL-C level goals,” said Professor David Nanchen, University of Lausanne, Center for Primary Care and Public Health (Unisanté), Lausanne, Switzerland. “These findings underscore the need for more widespread attention to better manage the risk of cardiovascular disease in women. ” Treatment adherence and the impact of non-adherence on patient outcomes Treatment for atrial fibrillation with oral anticoagulation relies on adherence and persistence to be effective. Non-persistence to single non-vitamin K antagonist oral anticoagulants (NOACs) has been associated with increased stroke risk in atrial fibrillation (AF) patients. 2 Daiichi Sankyo committed to ETNA-AF, which combines data from distinct non-interventional studies in Europe, East Asia, and Japan in a single database, to delve deeper into the global burden of CVD. More than 28,000 patients were included in the ETNA-AF registries and followed for four years in Europe and two years in countries outside Europe. 11 Results from a new post hoc sub-analysis of the ETNA-AF programme showed that, of the 9,417 [13,164 enrolled] (71.5%) patients who completed the 4-year study, 87.4% were persistent with edoxaban treatment. 3 Treatment discontinuation and non-persistence were both associated with factors including increasing age, male sex, body weight extremes, low renal function, heart failure, vascular disease, chronic hepatic disease, alcohol use, perceived frailty, chronic obstructive pulmonary disease, smoking, current AF symptoms, and ablation. 3 “The high number of patients who persisted with edoxaban treatment for the duration of the 4-year study is good news for our efforts to mitigate therapeutic non-adherence, 2 ” said Professor Raffaele De Caterina, MD, PhD, FESC, Director of Cardiology at Pisa University Hospital. “ We hope that the associated factors for non-persistence observed in the study will also assist the development of treatment strategies in clinical practice, for the benefit of patient outcomes.” Treatment for patients with frailty and comorbidities Barriers to recommending anticoagulation to manage non-valvular AF (NVAF), such as complex multimorbidities are significant in frail patients. 12 As such, the prescription of NOACs in the frail patient population is <50%. 12 Doctors are required to balance stroke risk and bleeding risk when making prescribing decisions. 12 Frailty is a common reason to choose non recommended doses of NOACs and so the four year follow up data from ETNA-AF were used to assess clinical outcomes in such patients. Patients with 'perceived' or objective frailty who were treated with a reduced (non-recommended) 30mg dose showed a higher rate of all-cause death versus the 60mg dose (HR [95% CI]: 1.44[1.06,1.96]) with no significant effect on major bleeding. This suggests that the presence of frailty per se should not necessarily drive dose reductions. 5 In a separate sub analysis of the data, patients were divided into low, middle and high tertiles based on body mass index (BMI), body surface area (BSA) and lean body mass (LBM). Rates of thromboembolic events were low (0.7-0.9%/100PY) and similar across tertiles. However, higher rates of any haemorrhagic events were observed in the low ([2.2–2.4%]) vs middle ([1.5–1.8%]) and high ([1.4–1.5%]) tertiles for BSA and LBM, suggesting that these variables, more than BMI, should be considered when analysing outcomes in patients treated with edoxaban. 4,6 “At Daiichi Sankyo, we continue in our long-term commitment to provide scientific evidence that can support the optimal treatment of patients with cardiovascular disease, and to find solutions for individuals who have previously been undertreated,” said Dr. Stefan Seyfried, Vice President Medical Affairs, Specialty Medicines, at Daiichi Sankyo Europe GmbH. “ Our promise to patients is to continue shining a light on treatment inequalities and unmet needs in cardiovascular care, with the goal of reducing the burden on patients and their loved ones. ” -ENDS- About SANTORINI The SANTORINI study is a multinational, prospective, observational study that enrolled 9,602 patients with high and very high CV risk from over 623 sites in 14 countries across Europe. Patients were recruited between March 2020 and February 2021. 10 The primary objective was to document, in the real-world setting, the effectiveness of current LDL-C management approaches in high- and very high-cardiovascular-risk patients requiring lipid-lowering therapies over a 1-year period. 10 The study included both previously diagnosed and treated patients and those newly diagnosed and requiring treatment. 10 Complete baseline data was included for 9,044 patients (mean age: 65.3 ± 10.9 years; 72.6% male). 10 Physicians used 2019 ESC/EAS guidelines as a basis for CV risk classification in 52% of patients; 29.2% of patients were classified as high risk and 70.8% as very high risk. 10 Central reassessment with the same guidelines classified 6.5% as high risk and 91% as very high-risk. 10 Overall, 21.8% of patients had no documented lipid lowering therapies (LLTs), 54.2% were receiving monotherapy and 24% combination LLT. 10 Median LDL-C was 2.1 mmol/L with 20.1% of patients achieving risk-based LDL-C goals as per the 2019 ESC/EAS guidelines. 10 About ETNA-AF ETNA-AF (Edoxaban Treatment in routiNe clinical prActice in patients with nonvalvular Atrial Fibrillation) is a global programme that combines data from distinct non-interventional studies in Europe, East Asia, and Japan in a single database. A total of more than 28,000 patients were included in the ETNA-AF registries and followed for two years (patients in Europe were followed for four years). 11 The primary objective of ETNA-AF was to collect information on the use of edoxaban in routine clinical practice, including the safety and efficacy profile in non-preselected patients with nonvalvular AF. 13,14,15,16,17 About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need. For more information, please visit https://www.daiichi-sankyo.eu/ References ________________________________ 1 Nanchen, D., et al. Contemporary LDL-cholesterol management in male and female patients at high-cardiovascular risk: results from the European observational SANTORINI study. Oral presentation, ESC Congress 30 August 2024. 2 Vitolo, M., et al. The importance of adherence and persistence with oral anticoagulation treatment in patients with atrial fibrillation. European Heart Journal – Cardiovascular Pharmacotherapy. 2021. 7;(FI1): f81–f83 3 Diemberger, I., et al . Persistence and predictors for non-persistence to edoxaban therapy in patients with atrial fibrillation: 4-year follow-up data from the ETNA-AF-Europe study. ESC Congress 2024 4 Boriani, G., et al . Impact of differences in body mass index, body surface area and lean body mass on clinical outcomes in patients with atrial fibrillation receiving edoxaban: 4-year follow-up data from ETNA-AF-Europe. ESC 2024 5 Fumagalli, S., et al . Edoxaban dose, frailty, and outcomes in patients with atrial fibrillation: the ETNA-AF-Europe 4-year follow-up. ESC 2024 6 Boriani, G., et al . Impact of body weight and body mass index on clinical outcomes of edoxaban therapy in atrial fibrillation patients included in the ETNA-AF-Global registry. ESC 2024 7 Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170 000 participants in 26 randomised trials. Lancet. 2010. 376(9753): 1670–1681 8 NHS England. Improving lipid management to reduce cardiovascular disease and save lives. Available at: https://www.england.nhs.uk/long-read/improving-lipid-management-to-reduce-cardiovascular-disease-and-save-lives/#:~:text=Raised%20LDL%20cholesterol%20is%20one,vascular%20events%20after%201%20year . Last accessed August 2024. 9 ESC. Cardiovascular Disease in Women. Available at: https://www.escardio.org/The-ESC/Advocacy/women-and-cardiovascular-disease . Last accessed August 2024. 10 Ray, K.K., et al. Treatment gaps in the implementation of LDL cholesterol control among high- and very high-risk patients in Europe between 2020 and 2021: the multinational observational SANTORINI study. Lancet . 2023. 29: 100624. 11 Daiichi Sankyo Europe – ETNA-AF (UK). Available at: https://www.daiichi-sankyo.eu/media/about-etna-af-uk/ . Last accessed August 2024. 12 Bul, M., et al. Frailty and oral anticoagulant prescription in adults with atrial fibrillation: A systematic review. Aging Medicine. 2022. 6(2): 195–206 13 Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (ETNA-AF-EU). Available at: https://clinicaltrials.gov/ct2/show/NCT02944019 . Last accessed August 2024. 14 Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN). Available at: https://clinicaltrials.gov/ct2/show/NCT02951039 . Last accessed August 2024. 15 Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF-Hong Kong). Available at: https://clinicaltrials.gov/ct2/show/NCT03247582 . Last accessed August 2024. 16 Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF). Available at: https://clinicaltrials.gov/ct2/show/NCT03247569 . Last accessed August 2024. 17 ETNA-AF-Japan. Available at: https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000019728 . Last accessed August 2024.

精彩内容 今年以来，葫芦娃药业新品研发喜讯不断，刚过去的7月，公司的富马酸丙酚替诺福韦片和布洛芬混悬滴剂获批上市并视同过评。目前葫芦娃药业及子公司共有1个中药经典名方、32个高端仿制药冲刺上市，有望在四大品类市场迎来新突破。作为儿童药明星企业，葫芦娃药业的新药研发也紧盯儿童药市场，3款新药正在火速推进，未来可期。 12个重磅新品获批，两个百亿市场大突破 葫芦娃药业长期以来聚焦儿童药领域，产品类别涵盖特色中药、化学药等，已构建起以儿童药为主，与成人药相结合的产品规划，围绕儿童的呼吸系统、消化系统、抗感染类和其他药物进行布局。 米内网数据显示，近两年公司的新品获批迎来爆发期：2023年共拿下3个新品，涉及呼吸系统用药、神经系统药物、心脑血管系统药物；2024年至今已有9个新品获批，涉及肌肉-骨骼系统（2个）、全身用抗感染药物（3个）、呼吸系统用药（4个）。 表1：2023年至今葫芦娃药业及子公司获批的新产品来源：米内网中国申报进度（MED）数据库 2023年11月，公司的缬沙坦氨氯地平片(Ⅰ)获批上市并视同过评，该产品用于治疗原发性高血压以及用于单药治疗不能充分控制血压的患者，该产品是葫芦娃药业首款获批的高血压用药。2023年在中国城市公立医院、县级公立医院、城市社区中心及乡镇卫生院（简称中国公立医疗机构）终端（化学药+生物药）市场，高血压用药的市场规模在470亿元以上，葫芦娃药业成功撬开了这个百亿市场大门。 2024年4月，公司的硫酸特布他林雾化吸入用溶液获批上市并视同过评，该产品用于缓解支气管哮喘、慢性支气管炎、肺气肿及其它肺部疾病所合并的支气管痉挛，适用人群包括成人及儿童。2023年在中国公立医疗机构终端（化学药+生物药）市场，吸入剂的市场规模在240亿元以上，硫酸特布他林雾化吸入用溶液是葫芦娃药业首款获批的吸入剂。 表2：葫芦娃药业已过评/视同过评产品情况来源：米内网中国申报进度（MED）数据库 2021年11月，葫芦娃药业的注射用阿奇霉素和注射用奥美拉唑钠过评，成为公司第一批过评的产品，具有积极意义，截至2024年8月27日，葫芦娃药业及子公司共有20个产品过评/视同过评。 有了充足的产品储备，葫芦娃药业也积极参与国家集中带量采购，在2023年举办的第八批、第九批国采中，公司分别中标了注射用头孢西丁钠（供应省份：吉林、上海、云南）、盐酸托莫西汀口服溶液（主供省份：江西、四川、甘肃、青海；备供省份：山东、陕西、天津、吉林）。值得注意的是，公司的盐酸托莫西汀口服溶液是2023年获批的新产品，“光脚产品”借助国采之力有望实现销售大放量，成绩值得期待。 目前，公司过评且暂未纳入国采的产品中，帕拉米韦注射液、布洛芬混悬液、地氯雷他定口服溶液3个产品的竞争企业（原研+过评）≥5家，若能进入第十批国采目录且顺利中标，葫芦娃药业这3个按新分类获批的“光脚产品”有望迎来新一轮爆发期，对公司业绩有提振作用。 首款中药经典名方备受瞩目，32个仿制药新品在路上 葫芦娃药业正在积极开发稳定性更好、顺应性更强的吸入制剂、口溶膜剂等技术壁垒高、市场前景广的新剂型儿科产品，开发速释、缓释、控释等高端新药制剂，瞄准国际高端新药研发和市场方向，为国内病患提供更优质、更前沿的创新产品。米内网数据显示，2023年至今，葫芦娃药业及子公司有1个中药新药、32个化药仿制药报产在审，涉及10个大类（23个亚类）。 表3：2023年至今葫芦娃药业及子公司报产在审的新产品 来源：米内网中国申报进度（MED）数据库 易黄颗粒是葫芦娃药业首款申报上市的中成药3.1类新药（即按古代经典名方目录管理的中药复方制剂）。资料显示，易黄汤为固涩剂，具有固肾止带，清热祛湿之功效，主治肾虚湿热带下，带下粘稠量多，色黄如浓茶汁，其气腥秽，舌红，苔黄腻者，临床常用于治疗宫颈炎、阴道炎等属肾虚湿热下注者。该新药目前仅有葫芦娃药业报产在审，大概率能拿下国产首家。 此外，枸橼酸托法替布口服溶液、维生素K滴剂、头孢托仑匹酯颗粒目前均未有国内药企获得生产批文，葫芦娃药业将参与3个产品的国内首仿争夺，值得期待。 目前公司暂无治疗便秘的化药、造影剂、免疫抑制剂、影响骨结构及其矿化的化药获批，乳果糖口服溶液、钆布醇注射液、枸橼酸托法替布口服溶液、注射用唑来膦酸浓溶液或将为公司开辟4个新市场。 儿童药新药加速推进，中成药+化药双布局 目前，我国儿童用药配备不足，呈现“三少两多”的市场特点，即儿童专用药品种少、剂型少、剂量规格少、普药多、不良反应情况多等情况。近几年国家对儿童用药关注度不断提升，各种鼓励儿童药研发的政策陆续出台，我国儿童药市场将迎来更广阔的发展前景。 葫芦娃药业表示，随着各项政策的落地，公司在儿童药领域的布局将进一步深入，尤其是在研发方面，将集中优势资源加快儿药项目的研发进程，更好的为广大儿童的健康做好服务。目前公司有两款中药新药和1款化药改良新药进展较快，均属于儿童药。 表4：葫芦娃药业及子公司在研的儿童新药 来源：米内网中国临床试验数据库 小儿化积颗粒用于小儿脾胃不和，停食停乳，积聚痞块，肚腹膨胀，四肢倦怠，面色萎黄，不思饮食等症。公司在2018年获得临床批件，目前已在III期临床阶段，上市可期。 小儿麻龙止咳平喘颗粒适用于素有风痰，郁而化热，痰热互结，肺失宣肃，气机上逆而致的反复咳嗽，夜间或晨起尤甚，伴痰粘难咯等症状者。公司在2018年获得临床批件，目前已完成II期临床。 LPC-006口溶膜是公司在2023年获批临床的化药改良新药，用于治疗抗癫痫病，属于二类精神药物。该新药是公司首款申报的口溶膜，为公司进军高技术壁垒药物市场奠定基础。 资料来源：米内网数据库、公司公告等 注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。数据统计截至8月27日，如有疏漏，欢迎指正！ 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。 投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。 把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下： 【分享、点赞、在看】点一点不失联哦