Zhejiang Wolwo Bio-Pharmaceutical Co.,Ltd. (300357.SZ) has announced that its indirectly controlled subsidiary, Zhejiang Wolwo Stem Cell Technology Co., Ltd. (hereinafter referred to as "Zhejiang Stem Cell"), recently obtained a Drug Clinical Trial Approval Notice downloaded from the National Medical Products Administration government services portal. The clinical trial application for the "Human Umbilical Cord Mesenchymal Stem Cell Type II Injection" (hereinafter referred to as "this product") submitted by Zhejiang Stem Cell has been approved.

As of the disclosure date of this announcement, no mesenchymal stem cell drugs for the treatment of sepsis and septic shock have been approved for marketing either domestically or internationally.

Sepsis is a clinical syndrome caused by a dysregulated host response to infection, leading to life-threatening organ dysfunction with a high mortality rate. Septic shock is sepsis complicated by severe circulatory, cellular, and metabolic abnormalities, carrying a higher risk of death than sepsis alone. The pathophysiological mechanisms of sepsis and septic shock are complex, often resulting in multiple organ dysfunction and poor prognosis. Surviving patients may suffer from cognitive impairment and organ insufficiency, with a diminished quality of life.

Currently, treatment strategies for sepsis and septic shock are mainly limited to supportive care and the use of broad-spectrum antibiotics. Despite continuous advances in fluid resuscitation, vasoactive drugs, and organ function support technologies, the mortality rate and incidence of long-term complications in patients with sepsis and septic shock remain persistently high, underscoring the urgent need for breakthrough therapeutic strategies.