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*Only for medical professionals to read for reference.
After twists and turns, the path to stroke neuroprotection is ahead! Edaravone double-target protection of dextrocampine opens the door to neuroprotection! "TASTE means taste in Chinese, and TASTE research is to make neuroprotective agents such a research, arouse more neuroprotective and clinical research success.
" -Professor Wang Yongjun.
On February 25, 2021, the Phase III clinical study results conference of the Treatment of Acute Ischemic STroke with Edaravone Dexborneol (TASTE) was held at Beijing Tiantan Hospital, Capital Medical University.
TASTE's research team, representatives of clinical trial units in each branch, and representatives of the research and development company Simcere Pharmaceutical attended the press conference.
Figure 1 The TASTE research results announcement site is worth mentioning that before (February 16), the official journal of the American Heart/Stroke Association (AHA/ASA) officially published the TASTE research results.
This large-scale clinical study from China has appeared in the international authoritative journal of cerebrovascular clinical research, and represents a major breakthrough for Chinese innovative drugs in this field! Professor Marc Fisher, former editor-in-chief of STROKE and chairman of the World Stroke Association (WSO), delivered a speech at the meeting, congratulating the publication of the research: Based on the results of the TASTE research, edaravone dextrocampine was approved for listing in China, which will be a great opportunity for the general public.
Chinese patients with ischemic stroke provide new treatment options and look forward to repeating this trial in the United States and other countries in the future, so that edaravone and dexcamphan can be promoted in more countries.
After 12 years of exploration, dual-target neuroprotective agents have highlighted the advantages of efficacy.
"TASTE research is in line with international standards, and the design and planning of the entire research are strictly followed by STAIR principles.
This is a key factor for this research to be internationally recognized."——Professor Xu Jie.
In 2007, the research and development of edaravone dexcamphanol project was launched, and the research was designed and implemented in accordance with STAIR principles.
Edaravone dexcamphanol is a dual-target drug and is compatible in a ratio of 4:1 Edaravone and dexcamphanol are two components.
Among them, edaravone can scavenge oxidative free radicals, reduce brain tissue damage and cerebral edema, and this effect is more obvious in the hyperacute phase; dextrocampine has anti-inflammatory effects, and Inflammation does not only occur in the hyperacute phase, but persists from 6 hours to 48 hours after the onset of onset.
In 2015, the phase III study of edaravone and dexborneol was initiated by the National Clinical Research Center for Neurological Diseases and Beijing Capital Medical University.
Professor Wang Yongjun of Tiantan Hospital took the lead in 48 medical centers across the country, and included nearly 1,200 patients with acute ischemic stroke (AIS) who had an onset of within 48 hours.
The
results showed that edaravone was the primary endpoint.
The proportion of subjects with a modified Rankin Scale (mRS) score of 0 to 1 in the alcohol group on day 90 was significantly higher than that in the edaravone group, 67.
18% and 58.
97% (OR: 1.
42, P=0.
004), mainly The efficacy endpoint results were basically the same among the subgroups.
The
results showed that the 90-day functional outcome of edaravone dextrocampine treatment within 48 hours after AIS was better than that of edaravone treatment.
The
positive result of the TASTE study was global The research and development of neuroprotective drugs injected a dose of stimulant and reopened the door to neuroprotection! Figure 2 TASTE research design In the view of Professor Xu Jie, the dual target mechanism of edaravone and dexcamphane is an important reason for its success in research and development.
.
"infarction itself is formed under the action of a variety of pathophysiological mechanisms, therefore, in future studies, preclinical testing, multi-target therapy, in conjunction with reperfusion therapy three points are very important, current clinical again There are more and more patients undergoing perfusion therapy.
In the era of reperfusion, there will be new brain cell protective agents and a new era will come.
"In addition, TASTE research is in line with international standards and strictly follows STAIR principles for the design and planning of the entire research.
This is also a key factor for this research to be internationally recognized. To break the shackles and try to reduce stroke disability, TASTE research is of great significance.
Professor Wang Yongjun said that at present, China is the country with the highest lifetime risk of stroke and the heaviest disease burden, with an incidence rate close to 40%.
Cerebrovascular disease is the disability of our people.
The primary reason.
Therefore, the future research focus on the prevention and control of cerebrovascular diseases in China is twofold: one is to reduce the incidence, and the second is to reduce the risk of disability after the onset.
The TASTE research is an attempt to reduce disability.
Figure 3 Professor Wang Yongjun's speech Professor Wang Yongjun introduced that this month, my country has just promulgated a new national medical quality control standard.
At present, there are two main methods for reducing disability, one is reperfusion therapy and the other is neuroprotective therapy.
Reperfusion therapy has been rated as one of the three most outstanding achievements in global cerebrovascular diseases in the past decade.
In recent years, reperfusion therapy has achieved rapid development.
In contrast, the exploration of neuroprotective agents in the treatment of stroke has been facing the dilemma of basic-clinical transformation.
"So far, more than 1,000 neuroprotective agents have been developed.
More than 900 animal tests have entered clinical trials and 114 have entered clinical trials.
Very few have really reached the end.
TASTE research is the first real breakthrough in evidence-based medicine.
Research on transformation barriers.
"The TASTE study has successfully completed the efficacy and safety verification of the Phase III clinical study of Edaravone Dexcamylol Injection Concentrated Solution, which represents a major breakthrough in China's innovative drugs in this field.
Reduce the disability caused by 130,000 strokes and save the socio-economic burden of 2.
3 billion yuan.
"Edaravone dexcampropanol brings great hope for reducing the disability of cerebrovascular diseases in China.
There are 1.
67 million new ischemic stroke patients in China every year.
If every stroke patient can use edaravone dexcamphanol, it can reduce the disability of 130,000 Chinese people due to stroke every year, save China's social and economic burdens by 2.
3 billion yuan, and also contribute to the development of brain cell protective agents in the future.
Provides a practical and successful example.
" said Mr.
Wang Feng, Vice President of Simcere Pharmaceuticals.
In December 2020, the concentrated solution of edaravone and dexcamphanol for injection entered medical insurance less than half a year after being approved for "running", which also demonstrated its clinical value and recognition from all walks of life.
Professor Wang Yongjun said that the time taken for edaravone dextrocampine from the approval to the entry of the medical insurance catalog to the international publication of the article is very short, indicating that the evidence-based medical evidence of the study is sufficient to be recognized by experts.
There are two main implications for its future: First, the Chinese people have used neuroprotective agents earlier than Western countries.
Second, it also establishes confidence for the future clinical research and development of other neuroprotective agents.
We look forward to the widespread use of edaravone and dextrocampine injection concentrated solution in the future, so that more stroke patients will benefit from it.
References: [1]Xu J, Wang A, Meng X,et al.
Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial.
Stroke.
2021 Mar;52 (3): 772-780.
doi: 10.
1161/STROKEAHA.
120.
031197.
Epub 2021 Feb 16.
PMID: 33588596
After twists and turns, the path to stroke neuroprotection is ahead! Edaravone double-target protection of dextrocampine opens the door to neuroprotection! "TASTE means taste in Chinese, and TASTE research is to make neuroprotective agents such a research, arouse more neuroprotective and clinical research success.
" -Professor Wang Yongjun.
On February 25, 2021, the Phase III clinical study results conference of the Treatment of Acute Ischemic STroke with Edaravone Dexborneol (TASTE) was held at Beijing Tiantan Hospital, Capital Medical University.
TASTE's research team, representatives of clinical trial units in each branch, and representatives of the research and development company Simcere Pharmaceutical attended the press conference.
Figure 1 The TASTE research results announcement site is worth mentioning that before (February 16), the official journal of the American Heart/Stroke Association (AHA/ASA) officially published the TASTE research results.
This large-scale clinical study from China has appeared in the international authoritative journal of cerebrovascular clinical research, and represents a major breakthrough for Chinese innovative drugs in this field! Professor Marc Fisher, former editor-in-chief of STROKE and chairman of the World Stroke Association (WSO), delivered a speech at the meeting, congratulating the publication of the research: Based on the results of the TASTE research, edaravone dextrocampine was approved for listing in China, which will be a great opportunity for the general public.
Chinese patients with ischemic stroke provide new treatment options and look forward to repeating this trial in the United States and other countries in the future, so that edaravone and dexcamphan can be promoted in more countries.
After 12 years of exploration, dual-target neuroprotective agents have highlighted the advantages of efficacy.
"TASTE research is in line with international standards, and the design and planning of the entire research are strictly followed by STAIR principles.
This is a key factor for this research to be internationally recognized."——Professor Xu Jie.
In 2007, the research and development of edaravone dexcamphanol project was launched, and the research was designed and implemented in accordance with STAIR principles.
Edaravone dexcamphanol is a dual-target drug and is compatible in a ratio of 4:1 Edaravone and dexcamphanol are two components.
Among them, edaravone can scavenge oxidative free radicals, reduce brain tissue damage and cerebral edema, and this effect is more obvious in the hyperacute phase; dextrocampine has anti-inflammatory effects, and Inflammation does not only occur in the hyperacute phase, but persists from 6 hours to 48 hours after the onset of onset.
In 2015, the phase III study of edaravone and dexborneol was initiated by the National Clinical Research Center for Neurological Diseases and Beijing Capital Medical University.
Professor Wang Yongjun of Tiantan Hospital took the lead in 48 medical centers across the country, and included nearly 1,200 patients with acute ischemic stroke (AIS) who had an onset of within 48 hours.
The
results showed that edaravone was the primary endpoint.
The proportion of subjects with a modified Rankin Scale (mRS) score of 0 to 1 in the alcohol group on day 90 was significantly higher than that in the edaravone group, 67.
18% and 58.
97% (OR: 1.
42, P=0.
004), mainly The efficacy endpoint results were basically the same among the subgroups.
The
results showed that the 90-day functional outcome of edaravone dextrocampine treatment within 48 hours after AIS was better than that of edaravone treatment.
The
positive result of the TASTE study was global The research and development of neuroprotective drugs injected a dose of stimulant and reopened the door to neuroprotection! Figure 2 TASTE research design In the view of Professor Xu Jie, the dual target mechanism of edaravone and dexcamphane is an important reason for its success in research and development.
.
"infarction itself is formed under the action of a variety of pathophysiological mechanisms, therefore, in future studies, preclinical testing, multi-target therapy, in conjunction with reperfusion therapy three points are very important, current clinical again There are more and more patients undergoing perfusion therapy.
In the era of reperfusion, there will be new brain cell protective agents and a new era will come.
"In addition, TASTE research is in line with international standards and strictly follows STAIR principles for the design and planning of the entire research.
This is also a key factor for this research to be internationally recognized. To break the shackles and try to reduce stroke disability, TASTE research is of great significance.
Professor Wang Yongjun said that at present, China is the country with the highest lifetime risk of stroke and the heaviest disease burden, with an incidence rate close to 40%.
Cerebrovascular disease is the disability of our people.
The primary reason.
Therefore, the future research focus on the prevention and control of cerebrovascular diseases in China is twofold: one is to reduce the incidence, and the second is to reduce the risk of disability after the onset.
The TASTE research is an attempt to reduce disability.
Figure 3 Professor Wang Yongjun's speech Professor Wang Yongjun introduced that this month, my country has just promulgated a new national medical quality control standard.
At present, there are two main methods for reducing disability, one is reperfusion therapy and the other is neuroprotective therapy.
Reperfusion therapy has been rated as one of the three most outstanding achievements in global cerebrovascular diseases in the past decade.
In recent years, reperfusion therapy has achieved rapid development.
In contrast, the exploration of neuroprotective agents in the treatment of stroke has been facing the dilemma of basic-clinical transformation.
"So far, more than 1,000 neuroprotective agents have been developed.
More than 900 animal tests have entered clinical trials and 114 have entered clinical trials.
Very few have really reached the end.
TASTE research is the first real breakthrough in evidence-based medicine.
Research on transformation barriers.
"The TASTE study has successfully completed the efficacy and safety verification of the Phase III clinical study of Edaravone Dexcamylol Injection Concentrated Solution, which represents a major breakthrough in China's innovative drugs in this field.
Reduce the disability caused by 130,000 strokes and save the socio-economic burden of 2.
3 billion yuan.
"Edaravone dexcampropanol brings great hope for reducing the disability of cerebrovascular diseases in China.
There are 1.
67 million new ischemic stroke patients in China every year.
If every stroke patient can use edaravone dexcamphanol, it can reduce the disability of 130,000 Chinese people due to stroke every year, save China's social and economic burdens by 2.
3 billion yuan, and also contribute to the development of brain cell protective agents in the future.
Provides a practical and successful example.
" said Mr.
Wang Feng, Vice President of Simcere Pharmaceuticals.
In December 2020, the concentrated solution of edaravone and dexcamphanol for injection entered medical insurance less than half a year after being approved for "running", which also demonstrated its clinical value and recognition from all walks of life.
Professor Wang Yongjun said that the time taken for edaravone dextrocampine from the approval to the entry of the medical insurance catalog to the international publication of the article is very short, indicating that the evidence-based medical evidence of the study is sufficient to be recognized by experts.
There are two main implications for its future: First, the Chinese people have used neuroprotective agents earlier than Western countries.
Second, it also establishes confidence for the future clinical research and development of other neuroprotective agents.
We look forward to the widespread use of edaravone and dextrocampine injection concentrated solution in the future, so that more stroke patients will benefit from it.
References: [1]Xu J, Wang A, Meng X,et al.
Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial.
Stroke.
2021 Mar;52 (3): 772-780.
doi: 10.
1161/STROKEAHA.
120.
031197.
Epub 2021 Feb 16.
PMID: 33588596
