On June 29, 2023, Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as "Sumgen Biotech") received approval from the National Medical Products Administration (NMPA) of China to conduct clinical trials for its Class 1 innovative therapeutic biological product SG301 SC for injection. The indication is for the treatment of systemic lupus erythematosus. SG301 SC is the first anti-CD38 antibody for subcutaneous injection approved for clinical trials in China, and it is also the first product from Sumgen Biotech approved for a non-oncology indication.
SG301 SC for injection is a subcutaneous injection formulation developed based on SG301 for injection (intravenous infusion). It can kill or induce apoptosis in plasma cells/plasmablasts with high CD38 expression through multiple mechanisms and inhibit the production of autoantibodies. It has the potential for clinical treatment of various autoimmune diseases. Non-clinical studies show that SG301 has a clear pharmacological effect and controllable safety, which supports the initiation of clinical trial research for systemic lupus erythematosus. Compared to intravenous injections, subcutaneous injections have obvious advantages. They can reduce the side effects caused by intravenous injections, significantly shorten the administration time, lessen the burden on both healthcare providers and patients, and improve patient compliance and the convenience of medication administration.
Dr. Ming Lv, founder of Sumgen Biotech, stated: "Autoimmune diseases affect 5% to 8% of the world's population, causing immense pain and burden to patients. The pathogenesis of autoimmune diseases is complex, and there is an urgent need for new treatment strategies clinically. The approval of clinical trials for SG301 SC for injection for the treatment of systemic lupus erythematosus marks the expansion of Sumgen Biotech's focus from oncology to other areas including autoimmunity. We will actively advance the clinical trials of SG301 SC for injection, further expand its application to other autoimmune diseases in the future, and bridge it with SG301 intravenous formulation to develop treatments for multiple myeloma and other indications, benefiting more patients."
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