On April 9, 2026, the Investigational New Drug (IND) application for SGT003, a novel foundational drug for tumor immunotherapy independently developed by Beijing Sungen Biomedical Technology Co., Ltd., a strategically holding subsidiary of Beijing Hotgen Biotech Co., Ltd., has been officially accepted by the National Medical Products Administration (NMPA). This marks that the promising First-in-Class candidate drug has entered a new clinical development phase after comprehensive preclinical research.
SGT003 is an innovative bispecific antibody developed based on Sungen Biomedical’s self-established NexTreg™ technology platform. Its core innovation lies in precisely eliminating regulatory T cells (Tregs) in the tumor microenvironment and activating anti-tumor immunity. The drug can accurately target tumor tissues, remodel the tumor microenvironment and trigger the body’s inherent immune response against tumor cells. It also reduces immune-related adverse reactions commonly seen in marketed anti-CTLA-4 antibody Ipilimumab, and can deliver therapeutic effects for patients with solid tumors resistant or unresponsive to conventional treatments.
As a vital target for immunotherapy, CTLA-4 inhibitors play an irreplaceable role in activating anti-tumor immune responses. Despite rapid expansion of the global tumor immunotherapy drug market, target options remain limited. The successful development of SGT003 stands as a major achievement of Sungen Biomedical’s in-depth research on tumor immune mechanisms and commitment to addressing unmet clinical needs, demonstrating breakthrough strength of Chinese pharmaceutical enterprises in original innovation.
The IND acceptance of SGT003 serves as a milestone in Sungen Biomedical’s innovative drug R&D journey, and another key achievement of Hotgen Biotech’s dual-driven strategy integrating diagnosis and treatment. It fully validates the company’s comprehensive capabilities in cutting-edge platform construction and original drug development. Going forward, Sungen Biomedical will develop multiple bispecific antibodies based on the NexTreg™ platform, break industry barriers through original innovation, and enhance the global recognition of Chinese innovative drugs in tumor immunotherapy.
Incubated by Hotgen Biotech, Sungen Biomedical is an innovation-oriented biotech company focusing on discovery, development and commercialization of First-in-Class antibody drugs. Boasting strong scientific research and drug development expertise, the firm has built multiple world-class technology platforms. Centered on unmet clinical demands, it has established abundant promising pipelines of original macromolecular drugs covering cardiovascular, cerebrovascular and oncology treatments. The company strives to advance China’s capacity for innovative biopharmaceutical production and safeguard human health worldwide.
Updated: May 26, 2026
