TRACE-III, another important research result of CSPC Mingfule in the field of ischemic stroke treatment, was published online in the top international medical j

At 8:00 on June 15, 2024 (Beijing time), TRACE-III, another important research result of CSPC Mingfule (tenecteplase, rhTNK-tPA) in the field of ischemic stroke treatment, was published online in the top international medical journal The New England Journal of Medicine (NEJM). This is another blockbuster clinical study of Mingfule published in top medical journals after the TRACE-II was published in The Lancet in February 2023.

This groundbreaking study was led by the team of Professor Wang Yongjun from Beijing Tiantan Hospital, Capital Medical University. Co-first authors include Professor Xiong Yunyun from Beijing Tiantan Hospital and Professor Bruce Campbell from Royal Melbourne Hospital, University of Melbourne, Australia. Professor Wang Yongjun is the corresponding author of the paper.

The TRACE-III focuses on thrombolytic therapy in patients with ischemic stroke without thrombectomy. It is the first study in the world that extends the time window of TNK intravenous thrombolysis from 4.5 hours to 24 hours safely and effectively. This milestone discovery breaks the time limit of traditional thrombolytic treatment, providing the possibility of treatment for more patients.

The study included 516 patients with ischemic stroke caused by large vessel occlusion. The results showed that patients who received tenecteplase within 4.5 to 24 hours after the onset of stroke had a significantly lower disability rate than those who received standard drug treatment. Specific data showed that the proportion of patients scored 0 or 1 according to the 90-day modified Rankin scale was 33.0% in the tenecteplase treatment group whilst only 24.2% in the standard drug treatment group. The efficacy and safety of tenecteplase have been widely recognized, and it has gradually become the first choice of thrombolytic drug for acute stroke.

An editorial issued by NEJM during the same period spoke highly of the TRACE-III, praising the study result as "an exciting advance in the treatment of acute stroke" and of "far-reaching global significance". The editorial points out that if the results are replicated in other populations, it will "improve functional outcomes in patients with large vessel occlusion stroke on an international scale", and this is of great significance for areas with deficient endovascular thrombectomy resources.

Mingfule, independently developed by CSPC, is China's first tenecteplase and has been approved for marketing for acute myocardial infarction and acute ischemic stroke. The groundbreaking clinical study result of Mingfule, which was published in top international medical journals, marks that the R&D level of domestic neurological drugs has been internationally recognized. CSPC will continue to be committed to the R&D of innovative drugs in this field, and proactively cooperate with global scientific research institutions to jointly promote the continuous development of acute stroke treatment and benefit more patients.