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Clinical Trial Application of Sumgen Biotech's First-in-class Same-Target ADC Drug SG2918 Accepted by NMPA

date:2023-07-31      source:

On July 31, 2023, Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as "Sumgen Biotech") announced that the clinical trial application for its independently developed first Class 1 innovative ADC drug, SG2918 for injection, has been accepted by the National Medical Products Administration (NMPA). The intended indication is for malignant tumors. This is the world's first ADC drug with the same target applied for clinical trials.

SG2918 for injection is an innovative ADC drug independently developed by Sumgen Biotech. It targets a potential focus in tumor immunotherapy and employs site-specific conjugation techniques and a new cleavable linker. The effective payload is a microtubule inhibitor, and it has good blood stability and can mediate a bystander effect. Non-clinical research results show that SG2918 has clear anti-tumor activity and a controllable safety profile. It demonstrates significant anti-tumor activity in multiple cancer models when used as a monotherapy, and can be used in combination with anti-PD-1 antibodies to synergistically exert anti-tumor effects.

Dr. Ming Lv, founder of Sumgen Biotech, said, "SG2918 is the first project in Sumgen Biotech's ADC portfolio, and it possesses multiple 'global firsts' elements. SG2918 is the world's first ADC drug targeting the same molecular target applied for clinical trials, and it is also a brand-new exploration in the mechanism of action of ADC drugs. The main pathways through which traditional ADCs exert anti-tumor activity are by specifically recognizing antigens on the surface of tumor cells and directly killing tumor cells through bystander effects. SG2918 exerts its anti-tumor effects mainly by modulating the body's immune system and can work synergistically with anti-PD-1 antibodies. Previously, the anti-PD-1 antibody enlonstobart developed by Sumgen Biotech has been accepted for NDA and has obtained conditional marketing authorization. Based on this, the clinical trial application for SG2918, which has a significant synergistic mechanism with anti-PD-1 antibodies, is of extraordinary importance. We look forward to SG2918 working in combination with anti-PD-1 antibodies to benefit more cancer patients."

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