On February 16, 2021, research data from the Phase III clinical trial (TASTE Trial) of Sanbexin (edaravone and dexborneol concentrated solution for injection) was published in STROKE, the official medical journal of American Heart Association (AHA/ASA).
The article is titled Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial and the corresponding author of the article is Professor Wang Yongjun of Beijing Tiantan Hospital, Capital Medical University.
On July 29, 2020, Sanbexin, category I innovative pharmaceutical developed independently by the Group, obtained the drug registration certificate issued by the NMPA. On December 28, 2020, Sanbexin has been included into the Drugs Catalogue for the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance ( “NRDL” ) (2020) released , and will benefit more stroke patients in the future.
The TASTE Trial included a total of 1,200 subjects and was completed at 48 clinical centres in China. The clinical trial data showed that edaravone and dexborneol concentrated solution for injection has better efficacy and comparable safety as compared to edaravone injection. Inclusion criteria included patients diagnosed as Acute Ishemic Stroke (AIS), and within 48 hours of AIS onset. AIS patients were randomized in 1:1 ratio into 2 treatment arms. Both groups being treated for 14 consecutive days on the basis of the usual clinical treatment.
The data showed that:
(1) Primary efficacy endpoint: the proportion of subjects with an mRS score of 0 to 1 in the edaravone and dexborneol group at the 90th day was substantially higher than that in the edaravone group, being 67.18% and 58.97% respectively (dominance ratio OR = 1.42, 95% CI: 1.12 ~ 1.81, P = 0.004).
(2) Safety: Safety and tolerability were good, with the incidences of adverse events and serious adverse events being comparable between the two groups.
The chairman of World Stroke Organization, Professor Marc Fisher commented, “The results of the trial led to the approval of this combination treatment for acute stroke patients in China, as well as in corporation into the national Chinese drug reimbursement scheme. This will allow for a large number of people in China to receive this treatment. It looks like this will substantially improve stroke treatment in China. We look forward to actually doing another trial in the US and other western countries to hopefully replicate the results. And then make it available in the United States and other countries.”
Professor Wang Yongjun added, “The trial is designed and executed in accordance with the STAIR (Stroke Treatment Academic Industry Roundtable) principles, and has proved that this new neuroprotection is superior to traditional neuroprotections. It is hoped that more clinicians will participate in post-marketing evaluations in the future, to inject new vitality into the development of new drugs for cerebrovascular diseases in China, and bring new hope to Chinese patients with cerebrovascular diseases. "
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