PEGylated Recombinant Human Growth Hormone Jintrolong Exhibits Good Long-Term Safety in Cynomolgus Monkeys and Human Pediatric Growth Hormone Deficiency Patients.

Jintrolong is a long-acting PEGylated recombinant human growth hormone (PEG-rhGH) developed for weekly injection in patients with pediatric growth hormone deficiency (PGHD). Although PEG modification of therapeutic proteins is generally considered safe, concerns persist about the potential for adverse vacuolation in tissues with long-term exposure to PEG-included therapies, particularly in children. We assessed the safety of Jintrolong in cynomolgus monkeys with an examination of vacuolation in the brain choroid plexus (CP) and reported long-term clinical safety data obtained from children with PGHD.

A simple and cost-effective assay for measuring anti-drug antibody in human patients treated with Adalimumab.

It has been reported that 90% of the anti-drug antibody (ADA) to Adalimumab in human patients bound to the TNF-binding area, resulted in the annual loss of responses to Adalimumab up to 24%. It is of urgency to develop a cost-effective and easy-to-use ADA diagnostic kit for diagnosis of potential drug-resistance in patients treated with Adalimumab in clinic hospitals to avoid the tremendous economic and human costs to patients and health-care providers. In this study, we reported the generations of mouse monoclonal and monkey polyclonal antibodies against Adalimumab as assay standards and positive quality controls respectively.

A toxicity study of multiple-administration human umbilical cord mesenchymal stem cells in cynomolgus monkeys.

Therapies based on stem cells have shown very attractive potential in many clinical studies. However, the data about the safety of stem cells application remains insufficient. The present study was designed to evaluate the overall toxicology of human umbilical cord mesenchymal stem cells (hUC-MSCs) in cynomolgus monkeys with repeated administrations.

[Study of recombinant stem cell factor].

Stem cell factor is an important hematopoietic growth factor. In this study, the human stem cell factor was produced by recombinant E. coli, and the structure and biological activity of the recombinant stem cell factor(rhSCF) was studied.

[Therapeutic Effects of rhIL-11 on Carboplatin-Induced Thrombocytopenia in Monkeys].

A model of myelosuppression with thrombocytopenia was produced in monkey by i.v. administration of carboplatin to the evaluate effects of rhIL-11 treatment in monkeys.

[Promotion of Thrombopoiesis by rhIL-11 in Normal and Myelosuppressed Mice].

Hematological effects of rhIL-11 on normal and myelosuppressed male BALB/c mice were observed. Mice were subcutaneously injected with rhIL-11 for 7 consecutive days, at the dose of 200 or 400 micro g/kg per day, peripheral blood platelet counts were moderately elevated on 5 days after administration and returned to base level within 4 days after discontinuation of injection. In myelosuppressed mice, treatment with rhIL-11 significantly ameliorated the degree of thrombocytopenia, the recovery of thrombocytopenia was also significantly accelerated at the dose range of 100 - 400 micro g/kg per day, and blood platelet counts reached pre-irradiated level after 13 - 15 days of treatment.