Shenyang, July 26th, 2024 / PRNewswire / - 3SBio (01530.HK) announced today that the III phase clinical trial (project number: TPO106) of recombinant human thrombopoietin injection (trade name: TPIAO) for the treatment of chronic liver disease-related thrombocytopenia (CLD-TP) patients undergoing elective invasive surgery has been completed recently with the research achieving the preset primary endpoint. 3SBio plans to submit a new indication application to the National Medical Products Administration (NMPA) soon.

The primary efficacy endpoint of this III phase clinical trial is to verify that rhTPO maintains perioperative platelet counts ≥ 50×109/L more effectively than placebo in patients with CLD-TP undergoing elective invasive surgery. The results showed that the proportion of subjects in the trial group (rhTPO) who maintained perioperative platelet counts ≥ 50×109/L was 85.00% (95% CI: 75.26, 92.00), while the proportion in the control group was 12.50% (95% CI: 4.19, 26.80). The response rate difference (trial group - control group) between the two groups was 67.90% (95% CI: 51.60, 84.20; P <0.0001). The above results indicate that the response rate of the trial group has significantly increased compared with the control group, and the primary efficacy endpoint has achieved a conclusion of effectiveness. There was no significant difference between the trial group and the control group in the incidence and severity of adverse events.

Thrombocytopenia is a common complication of chronic liver disease, and its severity is related to the severity of liver disease. Approximately 78% of liver cirrhosis patients exhibit platelet reduction of varying degrees. The main causes of platelet reduction in patients with chronic liver disease are decreased production of thrombopoietin (TPO), as well as other factors including splenic hyperfunction, increased platelet destruction, and virus-induced suppression of bone marrow. For chronic liver disease patients who require surgical treatment, thrombocytopenia can increase the risk of surgery-related bleeding events. At present, platelet transfusion is the main treatment measure to reduce the risk of surgical bleeding, but it is in short supply, has a short maintenance efficacy, and has risks such as transfusion reactions and potential transfusion infections, which limits its application. Chronic liver disease patients with comorbid thrombocytopenia urgently need more efficient and safer alternative therapies.

TPIAO is a recombinant human thrombopoietin injection independently developed by 3SBio. It has been approved for clinical use for chemotherapy-induced thrombocytopenia (CIT), primary immune thrombocytopenia (ITP) in adults, and primary immune thrombocytopenia (ITP) in children. The III phase clinical trial of this study has achieved the preset primary endpoint, marking a new milestone for 3SBio in the field of chronic liver disease and better meeting the clinical needs of a large number of chronic liver disease patients.

Dr. Lou Jing, Chairman and CEO of 3SBio, said: "Through long-term clinical practice, TPIAO has been proven to be a drug that doctors and patients can trust. We believe that it will continue to demonstrate excellent efficacy in the treatment of chronic liver disease patients with thrombocytopenia. Thrombocytopenia is related to many diseases and affects the related treatment process. The company will continue to expand the indications of TPIAO, tap the potential of the drug, and strive to benefit more patients."

About 3SBio

3SBio is a leading biopharmaceutical company integrating research and development, production, and sales, dedicated to improving the survival quality of patients with high-quality pharmaceuticals and benefiting human health. At present, the company has more than 100 national invention patent authorizations, more than 40 marketed products, covering a variety of treatment fields including nephrology, oncology, autoimmune diseases, ophthalmology, and dermatology. The company has four R&D centers, a national engineering research center for antibody drugs, and biopharmaceuticals and chemical drugs dual platforms, with a total of 29 products under research, of which 25 are new national drugs, and has five production bases that meet GMP standards. In the future, 3SBio will continue to uphold the concept of "cherish life, care about survival, and create life," and strive to build a globally leading Chinese biopharmaceutical company. For more information, please visit.

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