Peking University Third Hospital

NANJING, China, Oct. 30, 2024 /PRNewswire/ -- Oct 24th 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that a new clinical study with major clinical findings regarding Sanbexin (edaravone and dexborneol concentrated solution for injection) has been published at the 16th World Stroke Conference (WSC). According to the latest data, the administration of edaravone dexborneol (Sanbexin®) in patients with acute ischemic stroke (AIS) before receiving endovascular thrombectomy significantly improved neuro-function recovery and reduced disability from stroke. Continue Reading Professor Yongjun Wang presented a late-breaking oral presentation at WCS Presented as a WCS late-breaking oral presentation by Professor Yongjun Wang from Beijing Tiantan Hospital, the study entitled "Treatment of Acute ischemic Stroke with Edaravone dexborneal 2" ("TASTE-2") has caught wide spread attention among neurology academic circle in the world. Stroke is the leading cause of death and disability in adults in China, while AIS accounts for about 70% of all strokes. About 40% of AIS patients fall into the category of large vessel occlusion (LVO), a subtype of AIS with higher disability and mortality. After stroke, reperfusion treatments (e.g., thrombolysis and thrombectomy) are used to restores blood supply to the brain as soon as possible. The endovascular thrombectomy (EVT), an important advance in reperfusion therapy in recent years, can achieve recanalization in about 70% to 90% of patients with the LVO stroke, but only half of these patients achieve favorable brain function recovery A significant proportion of the patients who received EVT remain disabled to varying degrees after 90 days of treatment. TASTE-2 study is a multicenter, double-blind, randomized, placebo-controlled clinical study. From March 2022 to May 2023, a total of 1362 AIS patients with a large-vessel occlusion (LVO) in the anterior circulation were enrolled. Patients were randomly allocated (1:1) to receive edaravone dexborneol (edaravone, 30 mg; (+)-dexborneol, 7.5 mg) or placebo prior to EVT and continued twice a day over a consecutive period of 10-14 days. As a primary efficacy outcome, 379 (55.0%) patients in the edaravone dexborneol group and 333 (49.6%) in the placebo group achieved a mRS 0-2 at day-90 (odds ratio [OR] 1.24, 95% CI 1.00-1.54; risk ratio [RR] 1.11, 95% CI 1.00-1.23). All safety outcomes were similar between both groups. This suggests that Edaravone dexborneol could improve the favorable functional outcome at 90 days in AIS patients within 24-hour of symptom onset who underwent EVT. Sanbexin® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-targeted brain cell protection agent developed by Simcere Pharmaceutical Co., Ltd, and is the only approved innovative drug in the field of stroke treatment worldwide since 2015. Composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, the drug can significantly reduce brain cell injury or impairment caused by AIS. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants can reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for decades. However, due to the complexity of stroke pathophysiology, single-target drugs have been found to have limited efficacy and difficult to be developed clinically. On the other hand, the clinical study of multi-target brain cytoprotectants continue to progress. Previously, the TASTE study led by Professor Yongjun Wang's team in Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan in Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients who do not receive reperfusion treatment. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexn® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke. Sanbexin® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy, particularly before reperfusion, to further improve the effect of stroke treatment and reduce stroke disability. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NANJING, China, Oct. 25, 2024 /PRNewswire/ -- On October 24, 2024, TASTE-2, a Chinese innovative stroke drug study led by Professor Wang Yongjun from Beijing Tiantan Hospital, was published in an oral report at the 16th World Stroke Conference (WSC): brain cell protection combined with edaravone dexborneol (Sanbexin ®) in patients with acute ischemic stroke before endovascular thrombectomy significantly improved the proportion of patients who recovered neurological independence at 90 days and reduced the proportion of patients with disability. Continue Reading Professor Wang Yongjun from Beijing Tiantan Hospital gave oral lectures on behalf of the research team at the 16th WSC Conference on Late Breaking and SRTThrombectomy plus Sanbexin ® for further stroke reduction Stroke is the leading cause of death and disability in adults in China, and acute ischemic stroke (AIS) accounts for about 70% of all strokes. Among them, about 40% of patients belong to the risk subtype of large vessel occlusion (LVO), with higher disability and mortality. After stroke, treatment with "reperfusion", which is represented by thrombolysis and thrombectomy, restores blood supply to the brain as soon as possible. Endovascular thrombectomy (EVT) is an important advance in reperfusion therapy in recent years, which can achieve recanalization in about 70% to 90% of patients with LVO stroke, but only nearly half of patients recover well. A significant proportion of patients with EVT remain disabled to varying degrees after 90 days of treatment. The oral report on 2024WSC showed that a multicenter, double-blind, randomized, placebo-controlled TASTE-2 study enrolled 1362 patients with moderate-severe stroke treated with EVT. Edaravone dexborneol, a brain cell protection was used before EVT, and the proportion of patients with functional score 2 below 90 days was 55.0% vs. 49.6% compared with placebo, which was statistically significant and safe. This suggests that brain cell protection prior to stroke thrombectomy may further improve treatment outcomes in patients with large vessel occlusive stroke and help them regain self-care ability. TASTE-2 Primary Efficacy Results: There was a significant difference between the treatment and placebo groups in the proportion of patients who were functionally independent (90-day mRS 0 to 2), OR = 1.24 (1.00 to 1.54), p = 0.047; RR = 1.11 (1.00 to 1.23), p = 0.047 Sanbexin ® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-target brain cell protection developed by Simcere Pharmaceutical Co., Ltd. The drug contains two active ingredients, edaravone and dexborneol, which efficiently penetrate the blood-brain barrier, reduce cascade damage caused by AIS through dual effects of anti-inflammation and free radical scavenging, and extend the existing treatment window from 24 hours to 48 hours. As the only innovative drug approved for marketing and sales in the field of stroke treatment worldwide since 2015, this drug has been developed for 12 years. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexin ® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke and also trigger lively on-site discussion in international academia. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for a long time. However, for the complex pathophysiological mechanism of stroke, single-target drugs have limited efficacy and are difficult to develop clinically. Corresponding to this, multi-target brain cytoprotectants continue to progress in clinical practice. Previously, the TASTE study led by Professor Yongjun Wang 's team from Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan from Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients without thrombectomy, respectively. The data were published in STROKE (Stroke) and JAMA Neurology (American Medical Association Journal of Neurology), in 2021 and 2024. In the future, Sanbexin ® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy and administered before reperfusion to further improve the effect of stroke treatment and reduce stroke disability. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024年10月24日，北京天坛医院王拥军教授牵头的一项中国原创脑卒中新药研究TASTE-2在世界卒中大会上（WSC）以口头报告形式发表：急性缺血型卒中患者在血管内取栓治疗前，联合依达拉奉右莰醇（先必新®）进行脑细胞保护，显著改善了患者90天时恢复神经功能独立的患者比例，降低了患者致残比例 。 10月24日，北京天坛医院王拥军教授在阿联酋阿布扎比举行的第16届WSC大会最新科学研究（Late Breaking and SRT)专场做口头报告 取栓+先必新® 进一步为卒中减残 脑卒中是我国成年人致死、致残的首位病因，缺血性脑卒中（AIS）约占全部脑卒中的70%。而其中，又有约四成患者属于大血管闭塞型（large vessel occlusion，LVO）这一危险亚型，致残、致死率更高。 卒中发生后，以溶栓、取栓为代表的“再灌注”治疗，能尽快恢复大脑供血。血管内取栓术 (EVT)是近年来再灌注治疗的重要进展，可为约 70%~ 90%的LVO型卒中患者实现血流再通，但只有近一半的患者功能恢复良好。仍有相当比例EVT患者在治疗90天后存在不同程度的残疾。 2024WSC上的口头报告显示，一项多中心、双盲、随机、安慰剂对照的TASTE-2研究入组了1362名接受EVT治疗的中-重度卒中患者。在EVT前使用脑细胞保护剂依达拉奉右莰醇治疗，对比安慰剂，患者90天后功能评分2以下的比例为55.0% vs. 49.6%，差异具有统计学意义，且安全性良好。这表明，卒中取栓前给予脑细胞保护，可进一步改善大血管闭塞型卒中患者的治疗结局，帮助他们恢复自理能力。 TASTE-2主要疗效结果：治疗组与安慰剂组患者功能独立 (90天mRS 0~2分)比例有显著差异，OR=1.24 (1.00-1.54)，p=0.047；RR=1.11 (1.00–1.23)，p=0.047 先必新®（依达拉奉右莰醇注射用浓溶液）是先声药业自主研发的多靶点脑细胞保护剂，国家一类新药。该药物含依达拉奉和右莰醇两种活性成分，可高效透过血脑屏障，通过抗炎和清除自由基双效协同，减少AIS引发的级联损伤，并将现有治疗时间窗从24小时延长至48小时。作为全球脑卒中治疗领域自2015年来唯一获批上市销售的创新药，该药物历时12年研发，并获得2次国家科技部“重大新药创制”专项支持。 TASTE-2研究的最新结果，为先必新®作为多靶点脑细胞保护策略联合再灌注治疗急性缺血性脑卒中提供了关键性临床医学证据，也引发了国际学术界的现场热烈讨论。 新证据拓展“脑细胞保护”认知 根据卒中治疗学术界圆桌会议 (STAIR) 的建议，脑细胞保护剂可减少缺血性脑损伤，尤其是在与取栓联合时可产生协同作用。各国科学界也都曾长期致力于研究卒中治疗的脑细胞保护剂。然而针对卒中复杂的病理生理机制，单靶点药物疗效有限，临床开发有较大困难。 与之相对应的，是多靶点脑细胞保护剂在临床上不断取得进展。此前，北京天坛医院王拥军教授团队主导的TASTE研究，以及北京大学第三医院樊东升教授牵头的TASTE-SL研究，分别证实了依达拉奉右坎醇注射剂型，以及舌下片剂型对非取栓AIS患者的疗效。相关数据于2021年和2024年发表在国际神经病学顶级期刊STROKE（《卒中》）和JAMA Neurology（《美国医学会神经病学杂志 》），为医学界重启了卒中脑细胞保护研究的大门。依达拉奉右坎醇舌下片也于近日获美国食品药品监督管理局（FDA）“突破性疗法认定”，用于AIS治疗，是全球脑卒中治疗领域首个被FDA认定为突破性疗法的创新药。 天坛医院王拥军教授与王春娟教授代表研究团队在WSC现场介绍TASTE-2研究最新发现 为探究脑细胞保护与EVT的结合是否能为取栓的卒中患者带来更多获益，王拥军教授团队又进一步推动了TASTE-2研究，证实了AIS患者在取栓前使用先必新®可进一步获益，以新的临床证据不断拓展着科学对“脑细胞保护”的认知。 未来，先必新®有望作为取栓等血管内治疗的联合用药，在再灌注之前给药，进一步提升卒中治疗效果，减少卒中致残。 先声药业（2096.HK）是一家创新与研发驱动的制药公司，拥有“神经与肿瘤药物研发全国重点实验室”。本公司重点聚焦抗肿瘤、神经科学、自身免疫及抗感染领域，同时积极前瞻性布局未来有重大临床需求的疾病领域，致力于让患者早日用上更有效药物。本公司以自主研发及协同创新双轮驱动，与多家创新企业、科研院校建立战略合作伙伴关系。 www.simcere.com 撰稿 | 李逸玲 编辑 | 郭菁菁 审校 | 冯晓飞 王岚 审核 | 宋 洋  吴奕涵