Milestone | Sungen Biomed's Next-Generation Tumor Immunotherapy Backbone Drug SGT003 Completes First Subject Enrollment and Dosing

Recently, the clinical study (SUNVIA-101) of SGT003 Injection, a next-generation bispecific antibody drug for tumor immunotherapy independently developed by Sungen Biomed, a subsidiary of Hotgen Biotech, has successfully completed the enrollment and first dosing of the first subject. This marks SGT003's official transition from preclinical research to human clinical validation, representing a significant leap in the project's development process.



"SGT003 embodies our long-term thinking about next-generation tumor immunotherapy. Our goal is not to simply replicate the existing Keytruda or Opdivo models, but to address the core challenges of insufficient response and resistance to existing immunotherapies. By precisely modulating the tumor immune microenvironment, we are exploring a new generation of immunotherapeutic strategies that are more selective and more synergistic. First dosing is only the beginning of clinical validation. We will act on scientific data, take patient safety as the prerequisite, and steadily advance dose exploration, mechanism validation, biomarker research, and multi-tumor clinical development to progressively assess the true clinical value of SGT003."

SGT003 Injection is the world's first bispecific antibody candidate drug based on the NexTreg™ technology platform independently constructed by Sungen Biomed to enter clinical research (First-in-Human, FIH) . Its core innovation lies in the precise depletion of regulatory T cells (Tregs) in the tumor microenvironment, thereby activating anti-tumor immunity. This mechanism not only precisely targets tumor tissue, modulates the tumor microenvironment, and activates the body's own immune response against tumor cells to establish durable immune memory, but it also reduces CTLA-4-related immune activation toxicities. It has the potential to effectively cover a broad population of patients with solid tumors that are resistant or unresponsive to conventional therapies, and is expected to become a backbone drug for tumor immunotherapy.

From target discovery and molecular design to preclinical evaluation and the official launch of clinical trials, every step of SGT003's advancement has been built on a solid scientific foundation. The successful completion of this first dosing also lays a solid foundation for the steady progress of subsequent clinical studies.