3SBio Inc. (HKG: 1530), a biopharmaceutical company based in China, has announced the successful conclusion of the Phase III TPO106 clinical trial for its thrombopoietin drug in patients with chronic liver disease associated thrombocytopenia who are scheduled for invasive surgery. The trial has met its pre-set primary endpoint, paving the way for a supplementary market filing for the drug in this new indication.
The study demonstrated that 85.00% of subjects in the experimental group treated with recombinant human thrombopoietin (rhTPO) maintained a perioperative platelet count of at least 50 × 109/L, compared to only 12.50% in the control group. The significant difference in response rates, with an increase of 67.90% in the experimental group (95% CI: 51.60, 84.20; P<0.0001), underscores the drug’s efficacy in enhancing platelet counts prior to surgery. Notably, there were no significant differences in the incidence and severity of adverse events between the experimental and control groups, indicating a favorable safety profile.
3SBio’s proprietary recombinant thrombopoietin, marketed as TPIAO, was initially approved in China in 2005 for the treatment of chemotherapy-induced thrombocytopenia. It has since received additional approvals for the treatment of primary immune thrombocytopenia (ITP) in both adult and pediatric populations. Inclusion in the National Reimbursement Drug List (NRDL) since 2009 and an expanded indication listing in 2020 via renegotiation highlight the drug’s importance in the Chinese healthcare system.- Flcube.com
