Zhejiang Wolwo Bio-Pharmaceutical Co.,Ltd. (300357.SZ) has announced that its drug clinical trial application for "Human Umbilical Cord Mesenchymal Stem Cell Type II Injection" has been formally accepted by the National Medical Products Administration.
In June 2026, the company disclosed its decision to withdraw the previous clinical trial application. Following this, the indirectly controlled subsidiary, Zhejiang Wolwo Stem Cell Technology Co., Ltd. (referred to as "Zhejiang Stem Cell"), refined its pharmaceutical research and resubmitted the application. The company has now received an official "Acceptance Notice" from the regulatory authority.
As of the date of this announcement, no mesenchymal stem cell drug for treating sepsis and septic shock has been approved for marketing globally. Sepsis is a life-threatening clinical syndrome characterized by organ dysfunction resulting from a dysregulated host response to infection. Septic shock involves severe circulatory, cellular, and metabolic abnormalities, carrying a higher mortality risk than sepsis alone. The complex pathophysiology of these conditions often leads to multiple organ dysfunction and poor prognosis. Survivors may experience long-term cognitive impairment and organ dysfunction, significantly impacting their quality of life.
Current treatment strategies for sepsis and septic shock are primarily limited to supportive care and broad-spectrum antibiotics. Despite advances in fluid resuscitation, vasoactive agents, and organ support technologies, mortality rates and long-term complication rates remain high, underscoring the urgent need for breakthrough therapeutic approaches.
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