On February 2, 2026, Simcere Pharmaceutical Group (2096.HK) announced that its thrombolytic candidate drug for stroke, SIM0811, has recently initiated a Phase I clinical trial at Qilu Hospital of Shandong University and has successfully completed the enrollment of the first participant.
This randomized, double-blind, placebo-controlled Phase I study is led by Professor Chen Yuguo and Professor Zhao Wei at Qilu Hospital. The trial aims to evaluate the safety and pharmacokinetic characteristics of SIM0811 injection in healthy adult Chinese volunteers.
SIM0811 is a new-generation small-molecule plasminogen allosteric activator with a dual mechanism of action that combines thrombolytic and anti-inflammatory effects. On the one hand, it modulates the conformation of plasminogen (PLG) to enhance the efficiency of endogenous tissue plasminogen activator (tPA), thereby accelerating thrombus dissolution. On the other hand, by inhibiting soluble epoxide hydrolase, SIM0811 exerts anti-inflammatory and antioxidant effects at the thrombus site, reducing reperfusion-induced inflammation and vascular endothelial cell damage. This dual action may further minimize bleeding risks and provide potential neuroprotective benefits.
In preclinical studies, SIM0811 demonstrated superior thrombolytic efficacy and antioxidant activity compared with other investigational molecules of the same class. While traditional thrombolytic therapies such as tPA are limited by a narrow treatment window of approximately 4.5 hours, SIM0811 is expected to extend the therapeutic window to up to 24 hours, potentially benefiting a broader population of patients with acute ischemic stroke.
As an independently developed candidate drug of Simcere, SIM0811 has the potential synergize with the multi-target neuroprotective agent Sanbaxine (先必新®), offering a more comprehensive therapeutic strategy for ischemic stroke in the future.