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On May 7, China's antibody drug pioneer Sansheng Guojian announced that the company has recently received the "Drug Clinical Trial Approval Notice" approved and issued by the State Drug Administration (hereinafter referred to as the "State Drug Administration").
Its products - SSGJ-612 for injection will start clinical trials in the near future
.
SSGJ-612 evolved on the classic HER2 receptor.
It is the first therapeutic macromolecular monoclonal antibody that antagonizes the extracellular domain III of HER2 and has completely independent innovation from the mechanism of action to product development that has entered the stage of clinical development
.
In 2020, SSGJ-612 related research papers were published in the core journal Molecular Immunology, demonstrating the product's good anti-cancer effect and unique mechanism of action
Studies have shown that SSGJ-612 may inhibit the growth of HER2-positive tumor cells in a completely different way than trastuzumab and pertuzumab
.
Compared with trastuzumab alone or combined with Pertuzumab, the use of SSGJ-612 combined with trastuzumab or inituzumab has a stronger inhibitory effect on the proliferation of HER2-positive cancer cells
Currently, HER2 overexpression is common in breast cancer
.
Epidemiological data show that HER2-positive breast cancer accounts for about 20% to 25% of the total incidence of breast cancer.
Professor Zhang Jian, deputy director of the Department of Oncology of Fudan University Cancer Hospital and medical director of the Phase I Clinical Research Center, said: "I am very pleased that the SSGJ-612 clinical trial application has been approved, which brings us more possibilities for anti-HER2 treatment of tumors
.
Looking forward to it .
Dr.
Lou Jing, Chairman of Sansheng Guojian, said: "The approval of the SSGJ-612 new drug clinical application by the State Food and Drug Administration marks a new step for the company in the field of anti-HER2 therapy.
We look forward to the early launch of this product and provide more HER2 positives.
Cancer patients bring survival benefits
.
Sansheng Guojian will continue to devote itself to the research and development of innovative antibody drugs, continuously meet the unending clinical needs, and benefit more patients
