Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd. (300357.SZ) announced that its indirect controlling subsidiary, Zhejiang Wolwo Stem Cell Technology Co., Ltd., has received an acceptance notice from the National Medical Products Administration. The application for clinical trials of "Human Umbilical Cord Mesenchymal Stem Cell Type II Injection" submitted by the subsidiary has been formally accepted.
As of the date of this announcement, no mesenchymal stem cell drug for the treatment of sepsis and septic shock has been approved for marketing either domestically or internationally. Sepsis is a clinical syndrome with a high mortality rate, triggered by infection-induced dysregulation of the host response, leading to life-threatening organ dysfunction. Septic shock, a more severe condition than sepsis alone, involves serious circulatory, cellular, and metabolic disturbances and carries an even higher risk of death.
The pathophysiology of sepsis and septic shock is complex, often resulting in multiple organ dysfunction and poor prognosis. Survivors may experience long-term cognitive impairment and organ insufficiency, significantly impacting their quality of life. Current treatment strategies are primarily limited to supportive care and the use of broad-spectrum antibiotics. Despite advances in fluid resuscitation, vasoactive medications, and organ support technologies, mortality rates and the incidence of long-term complications among patients with sepsis and septic shock remain high, underscoring the urgent need for breakthrough therapies.
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