Hotgen Biotech's Subsidiary Receives NMPA Approval for Clinical Trial of First-in-Class Innovative Drug SGT003 Injection

Beijing Hotgen Biotech Co., Ltd. (688068.SH) announced that its subsidiary, Beijing Shunjing Biomedical Technology Co., Ltd., has received approval from China's National Medical Products Administration (NMPA) to proceed with clinical trials for its innovative drug candidate SGT003 Injection.

The NMPA issued a Drug Clinical Trial Approval Notice, clearing the investigational new drug (IND) application for SGT003 Injection. The regulatory green light marks a significant milestone for the biotech company's oncology pipeline.

SGT003 Injection represents a first-in-class novel bispecific antibody candidate developed on the company's proprietary NexTreg™ technology platform. It is the first drug of its kind to enter first-in-human (FIH) clinical studies, according to the company.

The drug candidate's core innovation lies in its ability to precisely eliminate regulatory T cells, or Tregs, within the tumor microenvironment while activating anti-tumor immunity. This dual mechanism allows SGT003 to target tumor tissues specifically, modulate the tumor microenvironment, and trigger the body's own immune response against cancer cells.

Importantly, the drug is designed to reduce the immune activation-related toxicities typically associated with CTLA-4 inhibition, a common side effect that limits the use of existing immunotherapies. This improved safety profile could extend treatment benefits to a broader population of solid tumor patients, including those who are resistant to or do not respond to conventional therapies.

If successful, SGT003 has the potential to become a foundational therapy in cancer immunotherapy, addressing a significant unmet medical need in the treatment of solid tumors.