Two Studies of CSPC Presented at the International Stroke Conference

Recently, the International Stroke Conference 2024 (ISC 2024) was held in Phoenix, USA, where scientific research results in the stroke field from around the world were presented. As a third-generation thrombolytic drug brand, CSPC Mingfule® (tenecteplase) was presented again with its outstanding scientific research results at the Conference.

01 TRACE-2 Study

Professor Xiong Yunyun from the Neurology Center of Beijing Tiantan Hospital, Capital Medical University, presented the analysis results of the TRACE-2 clinical trial on a subgroup of elderly stroke patients above 80 years in the Late-Breaking Science Session. This study demonstrates the efficacy and safety of tenecteplase (rhTNK-tPA) in elderly stroke patients.

The prevalence and severity of stroke increase significantly with age. Especially elderly people above 80 years are at a higher risk of stroke. Although the AHA/ASA and ESO guidelines do not specify a clear age limit for alteplase for thrombolysis, most previous studies excluded elderly patients above 80 years or included only a small number. Therefore, the efficacy and safety of tenecteplase in this population have been a focus of medical attention.

Tenecteplase is a new generation of thrombolytic drug derived from genetic modification of alteplase, and features a longer half-life and higher specificity for binding to fibrin. These advantages render tenecteplase a unique position in thrombolytic therapy. The TRACE-2 study is a multi-center, open-label, non-inferior, and randomized controlled clinical trial, in which the subgroup analysis aimed to explore whether 0.25 mg/kg tenecteplase was non-inferior to the standard thrombolytic therapy with alteplase in patients over 80 years of age who had not received endovascular therapy.

The results showed that in the mITT analysis, 90-day mRS 0-1 was reported in 51.6% of patients in the tenecteplase group and 31.4% of patients in the alteplase group, indicating that tenecteplase is not inferior to alteplase. Besides, the average 90-day mRS score and the results of per-protocol (PP) analysis regarding mRS 0-1 and mRS 0-2 indicated that tenecteplase tended to be superior to alteplase. With respect to safety, both groups showed no statistically significant differences in symptomatic intracerebral hemorrhage rate within 36 hours and 90-day mortality.

These results provide strong support for the application of tenecteplase in elderly stroke patients.

02 CHABLIS-T II Study

At the ISC 2024, Professor Cheng Xin from Huashan Hospital, Fudan University, presented the results of the CHABLIS-T II study, which evaluated the efficacy and safety of tenecteplase in patients with late-window acute ischemic stroke (AIS).

As a third-generation thrombolytic drug, tenecteplase has demonstrated significant advantages in treating AIS due to its high fibrin specificity, strong resistance to plasminogen activator inhibitors, and a longer plasma half-life. Previous studies have demonstrated that tenecteplase is comparably effective with the traditional drug alteplase in the therapeutic window of 4.5 hours after stroke onset.

The CHABLIS-T II study further expanded the therapeutic window, providing strong support for intravenous thrombolytic therapy in patients with late-window AIS. The study enrolled AIS patients within 4.5 to 24 hours after onset and used the strategy of multi-mode imaging-guided treatment. The results revealed that the tenecteplase group was significantly better than the control group in the reperfusion rate of main blood flows, and the adjusted hazard ratio reached 3.0, indicating the excellent efficacy of tenecteplase in the treatment of late-window stroke.

In addition, in-depth subgroup analyses were conducted in the study regarding occlusion site, time from onset to randomization, stroke onset scenario, history of endovascular therapy, and other factors. These analyses demonstrated that tenecteplase was consistently effective in all the patient subgroups, further confirming its extensive application prospects.

The results of the CHABLIS-T II study provide strong clinical evidence for the use of tenecteplase in patients with late-window AIS.

The important research results presented at the Conference demonstrate the significant role of CSPC's Mingfule ® (tenecteplase) in stroke treatment, and positively contribute to the progress of stroke treatment worldwide.

The new indication of Mingfule® for thrombolytic therapy of patients with acute ischemic stroke was approved by the National Medical Products Administration (NMPA) on February 5, 2024. Mingfule is the first product approved for the indication in China among similar products, and the indication is the second indication of this product approved in China after the indication of acute myocardial infarction.

CSPC will continue to conduct more related studies to explore the clinical potential of Mingfule® deeply. CSPC will also be committed to developing more innovative drugs in the field of heart and brain diseases to provide better treatment options to stroke patients worldwide.

This information is only an objective description of the Company's news events and shall not be taken as the basis for product recommendation.