Fully start Phase III clinical! Guoxin Pharmaceuticals has helped to conduct the first clinical trial of PEG-rhG-CSF biosynthic drugs in China

Recently, Hangzhou Jiuyuan Gene Engineering Co., Ltd. developed PEG-rhG-CSF injection clinical trial Phase I has completed all out of the group, the project Phase III clinical trial is responsible for the Chinese Academy of Medical Sciences Oncology Hospital, the main researcher is the Chinese Academy of Medical Sciences Oncology Hospital Vice President Professor Shi Yuankai.
is the first biosynthetic drug in China to prevent the reduction of neutral granulocytes after chemotherapy in cancer patients.
Guoxin Pharmaceuticals to undertake the entire course of the project clinical trial CRO services.
cancer is an important disease that threatens human life at present, chemotherapy is one of the main treatment methods.
And the reduction of neutral granulocytes caused by chemotherapy oncology is a common complication of chemotherapy in clinical practice, and the reduction of neutral granulocytes is one of the important reasons that cause infection, prolong hospital stay, delay treatment or decrease the dose of chemotherapy drugs, which affects the efficacy of chemotherapy.
Recombinant human granulocytic stimulation factor (rhG-CSF) is currently the most widely used and effective drug to prevent neugenic granulocyte reduction caused by tumor radiation chemotherapy, but its half-life is short (about 3.5 hours), easy to be hydrolyzed by enzymes and kidney removal, so in the course of chemotherapy needs daily administration for 7 to 10 days, patients with poor drug compliance.
Polyglycol recombinant human granulocyte stimulation factor injection (PEG-rhG-CSF) and rhG-CSF have the same mechanism of action, are by stimulating bone marrow hematopoietic stem cells to differentiate to granulocyte cells, promote cell proliferation, restore the number of peritopal blood nexus granulocytes.
PEG-rhG-CSF has a longer half-life (about 15-80h) and a longer duration of the drug, so a PEG-rhG-CSF injection after chemotherapy can achieve the same efficacy as multiple rhG-CSF injections.
(pictured is peG-rhG-CSF clinical trial project preparatory meeting of the Medical College) Hangzhou Jiuyuan Gene Engineering Co., Ltd. developed polyethyl glycol recombinant human granulocyte stimulation factor injection (PEG-rhG-CSF), has obtained the original State Food and Drug Administration clinical trial approval, will be in accordance with the "Biosylate Drug Research and Evaluation Technical Guidelines (Trial)" related requirements of clinical trials.
The nine-source gene PEG-rhG-CSF injection and the original PEG-rhG-CSF injection in healthy subjects compared with the biological equivalents of pharmacogenetics, pharmacodynamics, safety and immunogenicity, as well as the nine-source gene PEG-rhG-CSF injection and the original PEG-rhG-CSF injection phase III head-to-head clinical trial.
years, Guoxin Pharmaceuticals has provided clinical CRO services for innovative biopharmaceutical products to a number of biopharmaceutical enterprises, and has accumulated a large number of experience in the management and service of clinical trials in the field of biopharmaceuticals.
Guoxin Pharmaceutical has a professional innovative drug operation team, with hundreds of clinical research institutions in China have good relations of cooperation, according to the project situation and project needs to provide bidders with more clinical hospital options, to ensure that the project is completed efficiently and in high quality.