3SBio Inc. announces that the first patient has recently been enrolled in the trial of Phase III clinical study of recombinant human thrombopoietin (rhTPO) injection (trade name: TPIAO®) in the treatment of patients with chronic liver disease related thrombocytopenia who are candidates for invasive surgery (project number: TPO106). TPIAO® is a recombinant human thrombopoietin (rhTPO) injection developed by 3SBio, which has been approved for treatment of chemotherapy-induced thrombocytopenia (CIT) with solid tumors and immune thrombocytopenia (ITP) indications in adult patients. In 2022, the marketing application of TPIAO® in pediatric ITP indication was accepted by the National Medical Products Administration (NMPA) of China.

In the field of chronic liver disease, TPIAO® is also actively expanding its indications, and exploratory studies on safety, tolerability, pharmacokinetics (PK) and preliminary efficacy have been conducted on patients with chronic liver disease complicated with thrombocytopenia. Thrombocytopenia is a common complication of chronic liver disease, the degree of which is related to the severity of liver disease. About 78% of patients with liver cirrhosis have varying degrees of thrombocytopenia.

The main cause of thrombocytopenia in patients with chronic liver disease is decreased production of thrombopoietin (TPO). Other factors include hypersplenism, increased platelet destruction, and bone marrow suppression by virus. For patients with chronic liver disease requiring surgery treatment, thrombocytopenia can lead to increased risk of surgery-related bleeding.

At present, platelet transfusion is the main treatment to reduce the risk of surgical bleeding. However, its source is scarce and the curative effect is short-lived. It also carries risks of blood transfusion reaction and potential transfusion infection, limiting its application.

Patients with chronic liver disease complicated with thrombocytopenia urgently need more effective and safe alternative treatment methods.