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  • Milestone - SR1375'S Phase II Clinical Trial Approved by the US FDA


    On December 13, 2022,Shanghai SIMR Biotechnology Co., Ltd announced that, the candidate drug SR1375 with a new mechanism of action for the treatment of acute inflammation solely developed by the company, has been approved by the US Food and Drug Administration for its international multi-center phase II clinical study.


    Dr. Kai Wu, Co-CEO and Head of Clinical Development of SIMR, mentioned that: " Based on the latest scientific advances and translational research, SIMR discovered that SR1375 can inhibit inflammation and protect vascular endothelial cells. SR1375 is the company's second candidate drug whose international multi-center phase II clinical trial has been approved by the US FDA. This approval is the starting point and important milestone for SR1375’s global clinical development, and also represents the company's expansion of its pipeline and therapeutic areas into the inflammatory and further."


    About SR1375

    SR1375 is a first-in-class small molecule of anti-inflammatory mechanism, which can block the generation of inflammatory cytokines, protect vascular endothelial cells and thymic function, hence alleviate the progression of acute and chronic inflammation-related diseases. The first indication of SR1375 is diabetic macular edema (DME), and acute inflammation-related indications will be explored as second. SR1375’s patents have been submitted in over 20 countries, including the United States, Europe, Japan, Australia and emerging pharmaceutical markets such as Brazil and India. The phase I study results have shown that SR1375 had good safety, tolerability, and PK/PD characteristics.


    About SIMR

    SIMR is an innovation-oriented biopharmaceutical company dedicated to the discovery and development of new drugs for pain, inflammation and central nervous system related diseases. Since its establishment in 2014, the company has established a research and development platform of more than 3,000 square meters, with comprehensive drug development capabilities such as compound screening, CMC research, preclinical evaluation, and clinical development.