Clinical Trials of the First Bispecific Antibody SG12473 by Sumgen Biotech Was Approved in China and the United States

date:2021-04-30      source:

On April 30, 2021, Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as ‘Sumgen Biotech’) announced that the clinical trials of its proprietary SG12473 has been approved by the US Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA). SG12473 is a bispecific antibody targeted against both PD-L1 and CD47, which can simultaneously activate T cells by blocking the PD-1/PD-L1 signaling pathway and macrophages by blocking the CD47/SIRP-alpha signaling pathway, thus producing a synergistic antitumor effect. SG12473 has exhibited good antitumor activity in a variety of solid tumors and hematological tumor models in the non-clinical stage.

Clinical Trials of SG12473 Was Approved in China and the United States

CD47/SIRPα is one of the most important targets in the field of tumor immunity in the post-PD-1/PD-L1 era. Preliminary clinical studies and a large number of non-clinical studies have indicated that anti-CD47 drugs alone or in combination with other drugs had potent positive antitumor activity in hematologic tumors and a variety of solid tumors. However, due to the expression of CD47 on the surface of senescent red blood cells, CD47-targeting antibodies may result in side effects such as severe anemia. In the molecular design process of SG12473, the affinity of anti-PD-L1 antibodies is differentiated from that of CD47 inhibitors in order to redirecting the bispecific antibody to the tumor region with the help of the high affinity of anti-PD-L1 antibodies, so as to reduce its effect on red blood cells and improve efficacy at the same time.

Schematic Diagram of the Molecular Structure and Action Mechanism of SG12473

According to the head of Sumgen Biotech, SG12473 is the first bispecific antibody project and the fourth proprietary innovative drug of Sumgen Biotech that has been approved for clinical trials. Simultaneous approval of this project in China and the United States is the embodiment of further improvement in the company's antibody technology system. The company has made temporary breakthroughs in various technology subdivisions such as monoclonal antibodies, antibody fusion proteins, bispecific antibodies and ADCs. The company has deployed a number of ‘1+1>2’ bispecific antibody projects in the field of bispecific antibodies, which is an important part of the future R&D pipeline. The approval of SG12473 for clinical trials indicates that the bispecific antibodies layout of the company has entered a temporary harvest period. Obtaining approval for clinical trials in both China and the United States is also an important milestone in the gradual internationalization process of the company. The company will set up overseas clinical teams to launch international multi-center clinical studies sometime according to the progress of different projects.

Sumgen Biotech

Sumgen Biotech, a biopharmaceutical enterprise currently at the clinical development stage, is devoted to the R&D of innovative antibody drugs for major diseases such as cancer. Sumgen Biotech has successively received funding from Hankang Capital, National Vaccine and Serum Institute, and Addor Capital and entered into cooperation agreements with Shijiazhuang Pharmaceutical Group and National Vaccine and Serum Institute. Sumgen Biotech is currently pushing forward with the construction of a world-leading antibody drug production base. Sumgen Biotech is striving to become the world's leading biopharmaceutical enterprise with continuous innovation capability and the ability to offer China's antibody products to the world.

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