Gelonghui, April 12 | Sansheng Pharmaceutical (01530.HK) announced that the new indications for Sansheng Pharmaceutical's recombinant human thrombocytopenia (Terbiao) injection submitted by the company to the National Drug Administration (NMPA) were approved on April 2 to treat persistent or chronic primary immune thrombocytopenia (ITP) in children or adolescents.
Terbiao is a recombinant human thrombopoietin (rHTPO) injection independently developed by Sansheng Pharmaceutical. It has previously been approved for use in adults with post-chemotherapy thrombocytopenia (CIT) and adult primary immune thrombocytopenia (ITP). Currently, recombinant human thrombocytopoietin injection is the preferred second-line treatment recommended by the Chinese ITP Guidelines.
Primary immune thrombocytopenia (ITP) is an acquired autoimmune hemorrhagic disease. ITP in children often manifests as sudden petechiae, ecchymosis, or bleeding in healthy children. Occasionally, patients have thrombocytopenia during a complete blood count due to other conditions. Previously, in order to meet the clinical treatment needs of ITP in children and respond to the national call to develop drugs for children, Sansheng Pharmaceutical initiated phase III clinical studies on ITP indications in children at 10 children's hospitals and general hospitals across the country. The main efficacy index of the trial was overall efficiency.
Dr. Lou Jing, Chairman and CEO of Sansheng Pharmaceutical, said, “Terbiao has proven to be trustworthy in long-term clinical practice, and we believe it will continue to perform well in the treatment of pediatric ITP patients. Approval of pediatric ITP indications will improve its accessibility in pediatric clinical practice and better meet the clinical treatment needs of pediatric ITP patients in China. In the future, Sansheng Pharmaceutical will continue to be committed to the research and development of high-quality biopharmaceuticals to benefit more patients and families.”