SK10 Receives NMPA Phase II IND Approval for the Prevention and Treatment of Chemotherapy-Induced Diarrhea
Release Time: 2026-08-20
August 20, 2026 – SK10 (Inactivated Bacteroides fragilis), developed by ZYBio, has received NMPA approval to initiate a Phase II clinical trial for the indication of chemotherapy‑induced diarrhea (CID).
SK10 is the first Bacteroides fragilis‑based LBP (Live Biotherapeutic Products) candidate to receive FDA clearance for clinical development, and it is also the world’s first LBP candidate to be filed for CID. Furthermore, SK10 is the only LBP globally that is currently in clinical‑stage development for both the prevention and treatment of CID. Based on the favorable safety and tolerability results from a randomized, double‑blind, placebo‑controlled Phase I clinical trial completed in the United States, the NMPA has granted approval for SK10 to proceed to Phase II.
The research team has found that inactivated Bacteroides fragilis exhibits significant preventive and therapeutic effects against CID. In animal models of CID, SK10 has been shown to significantly reduce the incidence of moderate‑to‑severe diarrhea, inhibit the increase in intestinal permeability, substantially ameliorate intestinal mucosal damage and inflammatory cell infiltration, and lower histopathological scores of intestinal tissues. Mechanistic studies indicate that SK10 alleviates chemotherapy‑induced intestinal mucosal injury and associated diarrheal symptoms by repairing the intestinal mechanical barrier and modulating the intestinal immune barrier. In addition, the inactivated formulation offers enhanced safety for oncology patients and demonstrates superior commercial potential.
About Chemotherapy‑Induced Diarrhea (CID)
CID refers to diarrhea caused by cytotoxic drugs or small‑molecule targeted agents during chemotherapy. Data show that the overall incidence of diarrhea with 5‑fluorouracil and irinotecan ranges from 50% to 80%, while EGFR inhibitors such as afatinib, neratinib, and pyrotinib are associated with an overall incidence of 75% to 90%. Currently, there are no preventive measures for CID, and treatment options remain limited: loperamide is indicated for short‑term symptomatic management, but long‑term use can lead to intestinal obstruction; octreotide has significant adverse effects and requires intravenous or subcutaneous administration. CID is a major factor leading to chemotherapy adjustment, delay, or even discontinuation, severely impacting the survival time and quality of life of cancer patients, and thus represents a critical unmet medical need.