WOLWOPHARMA Subsidiary Receives NMPA Approval to Initiate Clinical Trials for Human Umbilical Cord Mesenchymal Stem Cell Type II Injection

BEIJING—Zhejiang Wolwo Biopharmaceutical Co., Ltd. (WOLWOPHARMA) announced on October 11 that its indirectly controlled subsidiary, Zhejiang Wolwo Stem Cell Technology Co., Ltd., has received approval from China's National Medical Products Administration to initiate clinical trials for a human umbilical cord mesenchymal stem cell therapy.

The Drug Clinical Trial Approval Notice, obtained through the NMPA's government services portal, clears the path for the subsidiary's Human Umbilical Cord Mesenchymal Stem Cell Type II Injection to advance into human testing. The investigational therapy is indicated for the treatment of sepsis and/or septic shock—life-threatening conditions that arise when the body's response to infection causes widespread inflammation and organ dysfunction.

Sepsis represents a significant unmet medical need globally, with high mortality rates and limited therapeutic options. According to the World Health Organization, sepsis is a leading cause of death worldwide, affecting millions of patients annually. The approval marks a milestone in WOLWOPHARMA's expansion into regenerative medicine through its stem cell subsidiary.

The clinical trial authorization allows Zhejiang Wolwo Stem Cell Technology to proceed with investigating the safety and efficacy of the mesenchymal stem cell injection in patients suffering from sepsis and related complications. Mesenchymal stem cells derived from umbilical cord tissue have shown promise in preclinical studies for their immunomodulatory and anti-inflammatory properties, which could potentially help mitigate the cytokine storm associated with severe sepsis.

WOLWOPHARMA, best known for its portfolio of allergy treatments including the sublingual immunotherapy products Dust Mite Drops and Dust Mite Tablets, is diversifying its pipeline through the stem cell subsidiary's regenerative medicine initiatives. The company's indirect stake in the stem cell business provides exposure to the rapidly growing cell therapy sector while maintaining operational separation from its core pharmaceutical operations.

The company did not disclose the specific timeline for patient enrollment or the phase of clinical trials authorized. Further details regarding trial design, study sites, and investment commitments are expected to be disclosed as the program progresses.