TRACE-III Clinical Study of CSPC Mingfule Presented at European Stroke Organisation Conference

At the 10^th European Stroke Organisation Conference (ESOC) held recently in Basel, Switzerland, the TRACE-III clinical study of Mingfule (recombinant human TNK tissue-type plasminogen activator for injection, rhTNK-tPA) developed by CSPC achieved remarkable results. This multi-center, prospective, open-label, blinded endpoint, and randomized controlled IIT clinical trial carried out by the team led by Professor Wang Yongjun from Beijing Tiantan Hospital, Capital Medical University successfully demonstrates that within 4.5 to 24 hours after the onset, for patients with acute ischemic stroke who are not suitable for endovascular treatment due to anterior circulation aorta occlusion, intravenous thrombolytic therapy with TNK can remarkably reduce the patients' disability rate and exhibits validated safety profile and effectiveness.

The announcement of TRACE-III elicited a great response on the spot. The result not only brings new hope for patients with acute ischemic stroke, but also marks a breakthrough in the time window of treatment with CSPC TNK. The clinical application of thrombolytic drugs such as Tenecteplase is mainly limited to the golden time window within 4.5 hours after the onset, but the success of TRACE-III extended this time window to 24 hours, providing more patients with the possibility of treatment.

The main inclusion criteria of the TRACE-III were acute ischemic stroke patients within 4.5-24 hours of onset (including wake-up stroke and unwitnessed stroke) who are not suitable for endovascular treatment with occlusion of large arteries (ICA, M1, M2) according to MRA/CTA and savable brain tissues according to CT and MRI perfusion images. Key imaging inclusion criteria of the study included infarct core volume less than 70 mL, mismatch ratio not less than 1.8, and mismatch volume not less than 15 mL. The primary outcome of the study was the proportion of non-disabled patients (mRS≤1) on Day 90, while safety outcomes included 90-day mortality, 36-hour symptomatic intracranial hemorrhage rate, etc.

In the TRACE-III, CSPC TNK demonstrated excellent therapeutic effect and safety. The trial showed that intravenous thrombolytic therapy with TNK can significantly reduce the rate of disability in patients who met the indications, without causing a significant increase in severe adverse reactions. The result not only proves the effectiveness of TNK in the treatment of acute ischemic stroke but also demonstrates its great potential for extension of the time window.

The success of the TRACE-III marks an important milestone for CSPC's unceasing innovation and development in the field of neurological diseases. In the future, we will continue to develop more innovative drugs and provide more high-quality, efficient treatment options for patients worldwide. At the same time, CSPC will also proactively promote the research results of TRACE-III to help more patients get rid of diseases and regain health.

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