Today, Junshi Biopharmaceuticals announced that the company received the "Notice of Drug Clinical Trial Approval" issued by the National Medical Products Administration, and the clinical trial application for JS007 injection (project code "JS007") was approved.
It is reported that JS007 is a recombinant humanized anti-CTLA-4 monoclonal antibody injection independently developed by the company, which is mainly used for the treatment of advanced malignant tumors.
Cytotoxic T lymphocyte associated antigen-4 (CTLA-4) is an important receptor on the surface of T cells to regulate immune responses.
JS007 can specifically bind to CTLA-4 and effectively block the interaction between CTLA-4 and its ligand B7 (CD80 or CD86), thereby activating T lymphocytes and inhibiting tumor growth.
At present, the same target foreign drug ipilimumab, as the first immune checkpoint inhibitor, has been proven to be significant in multiple tumor types such as melanoma, lymphoma, renal cell carcinoma, urothelial cancer, ovarian cancer, and non-small cell lung cancer.
The anti-tumor effect of the drug, and was approved for the treatment of advanced melanoma.
Pre-clinical research data show that JS007 has similar safety compared to ipilimumab, which has the same target but has a different sequence, but has better efficacy.