NANJING, China, Feb. 20, 2024 /PRNewswire/ -- On February 19, 2024, the Journal of American Medical Association•Neurology (JAMA NEUROLOGY, IF: 29.0) published online the key findings of a phase III clinical study (NCT04950920) (the 'TASTE-SL Study') investigating Sanbexin® (a combination of edaravone and dexborneol) sublingual tablets for the treatment of acute ischemic stroke (the 'AIS').The findings indicate that Sanbexin® sublingual tablets has substantially enhanced neurological functions and independence in daily living activities among AIS patients following the treatment..

南京，中国，2024年2月20日/PRNewswire/-2024年2月19日，《美国医学会神经病学杂志》（JAMA Neurology，IF:29.0）在线发布了一项III期临床研究（NCT04950920）（“TASTE-SL研究”）的主要发现，该研究调查了Sanbexin®（依达拉奉和右旋冰片的组合）舌下片剂治疗急性缺血性中风（“AIS”）。研究结果表明，Sanbexin®舌下片剂在治疗后的AIS患者中具有显着增强的神经功能和日常生活活动的独立性。。

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JAMA-Neurology paper published online Feb.19

JAMA神经病学论文2月19日在线发布

TASTE-SL study design

TASTE-SL研究设计

TASTE-SL study primary end point

TASTE-SL研究主要终点

Sanbexin® sublingual tablets is an innovative drug jointly developed by Simcere Pharmaceutical Group Ltd. ('Simcere') and Neurodawn Pharmaceutical Co., Ltd. ('Neurodawn'). The Sanbexin® sublingual tablets is expected to become a sequential therapy with Simcere's marketed Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) and allow patients to receive a complete course of treatment both in and outside of the hospital.

Sanbexin®舌下片剂是由Simcere Pharmaceutical Group Ltd.（“Simcere”）和Neurodawn Pharmaceutical Co.，Ltd.（“Neurodawn”）联合开发的创新药物。Sanbexin®舌下片剂有望成为Simcere上市的Sanbexin®（依达拉奉和右旋冰片浓缩注射液）的序贯疗法，并使患者在医院内外接受完整的治疗过程。

On June 28, 2023, the New Drug Application (NDA) of the Sanbexin® sublingual tablets was accepted by the National Medical Products Administration of China (the 'NMPA'). The first indication is for the improvement of neurological symptoms, activities of daily living, and functional disabilities caused by AIS..

2023年6月28日，Sanbexin®舌下片的新药申请（NDA）被中国国家医药产品管理局（“NMPA”）接受。第一个适应症是改善AIS引起的神经症状，日常生活活动和功能障碍。。

Sanbexin® sublingual tablet offers a novel approach to stroke treatment, leveraging the power of edaravone and dexborneol. The two active ingredients dissolve quickly under the tongue and are rapidly absorbed into the bloodstream via the sublingual venous plexus, providing unparalleled anti-inflammatory and free radical scavenging capabilities.

Sanbexin®舌下片剂利用依达拉奉和右旋冰片的功效，为中风治疗提供了一种新方法。这两种活性成分在舌头下迅速溶解，并通过舌下静脉丛迅速吸收到血液中，提供无与伦比的抗炎和自由基清除能力。

By minimizing the cascading damage caused by AIS and protecting brain cells, this innovative formulation has the potential to expand treatment options and improve patient compliance. With its innovative sublingual delivery system, Sanbexin® is poised to revolutionize stroke care.The TASTE-SL study, published in JAMA Neurology, is a Phase III clinical trial that evaluated the safety and efficacy of Sanbexin® sublingual tablets in AIA patients.

通过最大限度地减少AIS引起的级联损伤并保护脑细胞，这种创新配方有可能扩大治疗选择并提高患者依从性。凭借其创新的舌下输送系统，Sanbexin®有望彻底改变中风护理。TASTE-SL研究发表在JAMA Neurology上，是一项III期临床试验，评估了Sanbexin®舌下片剂在AIA患者中的安全性和有效性。

This multi-center, randomized, double-blind, placebo-controlled study enrolled 914 AIS patients within 48 hours of onset at 33 research sites in China from June 28, 2021, to August 10, 2022. Of these, 450 patients in the Sanbexin® sublingual tablets group received 36mg dose of sublingual edaravone dexborneol (edaravone 30mg, dexborneol 6mg) twice a day for 14 consecutive days), while 464 patients in the placebo group received a sublingual placebo (edaravone 0mg, dexborneol 60μg) twice a day for 14 consecutive days.The findings from the clinical trial suggest that the Sanbexin® sublingual tablets offer significant benefits for the treatment of AIS.

这项多中心，随机，双盲，安慰剂对照研究于2021年6月28日至2022年8月10日在中国33个研究地点招募了914名AIS患者，发病48小时内。其中，Sanbexin®舌下片剂组450名患者连续14天每天两次接受36mg剂量的舌下依达拉奉右冰片（依达拉奉30mg，右冰片6mg），而安慰剂组464名患者连续14天每天两次接受舌下安慰剂（依达拉奉0mg，右冰片60μg）。临床试验的结果表明，Sanbexin®舌下片剂为AIS的治疗提供了显着的益处。

The study, which included 302 patients, showed that those taking Sanbexin® sublingual tablets had a higher proportion of good functional outcomes (mRS score 0-1) on day 90 post-randomization compared to the placebo group: – 64.4% vs. 54.7%. The odds ratio was 1.50 (95% CI 1.15-1.95, p=0.003).Subgroup analyses of different demographic and clinical c.

这项包括302名患者的研究表明，与安慰剂组相比，服用Sanbexin®舌下片剂的患者在随机化后第90天的良好功能结果（mRS评分0-1）比例更高：–64.4%比54.7%。优势比为1.50（95%可信区间为1.15-1.95，p=0.003）。不同人口统计学和临床c的亚组分析。