Innovative Drugs

Antibody Drugs

Antibody drugs are precision-targeted biotherapeutic agents. Their core principle is to mimic the body's native immune antibodies, accurately recognizing and binding to diseased cells and pathogenic proteins in vivo. This precision sets them apart from conventional chemotherapeutic agents, which carry substantial side effects. Through four generations of technological iteration, antibody drugs have evolved from early mouse-derived antibodies—once prone to immune rejection—to safe and stable fully human antibodies, greatly reducing adverse immune reactions in patients. Major clinical antibody modalities today include monoclonal antibodies, antibody-drug conjugates (ADCs), bispecific antibodies, and the emerging antibody-oligonucleotide conjugates (AOCs). They are widely applied in oncology, autoimmune disorders, cardiovascular diseases, ophthalmology, and the treatment of rare diseases. Conventional monoclonal antibodies exert therapeutic effects by blocking pathogenic signaling and activating the host immune system to eliminate lesions. ADCs combine the targeting specificity of antibodies with the cytotoxic potency of chemotherapeutic agents to achieve site-specific tumor therapy. Bispecific antibodies engage two distinct targets simultaneously to enhance therapeutic efficacy. As a next-generation conjugate modality following ADCs, AOCs fuse targeting antibodies with oligonucleotide-based gene therapeutics. They overcome the delivery limitations of conventional small-nucleic-acid drugs, enable precise modulation of disease-causing genes, and address unmet medical needs for extra-hepatic tissue lesions and rare genetic disorders. Featuring high target precision and durable therapeutic effects, antibody drugs are large-molecule biologic agents that can only be administered via injection. Their R&D and manufacturing processes are technically complex and relatively costly, making them cornerstone therapeutics in modern precision medicine.

World Class Technology Platforms

Guided by national strategic imperatives and a commitment to original innovation, Sungen is dedicated to advancing antibody drug development to internationally leading standards. Sungen's mission is to build a differentiated product pipeline of First-in-Class and Best-in-Class candidates through front-end innovation. Backed by internationally advanced technology platforms — including the fully human antibody engineering platform, the X-Gen AI-powered drug discovery and antibody optimization platform, the antibody pilot-scale process development and manufacturing platform, the NexTreg™ technology platform, proprietary intellectual property-based ADC technology platform, and a comprehensive pharmacology and pharmacodynamics research platform — Sungen is advancing a robust portfolio of pioneering antibody drug candidates across cardiovascular and cerebrovascular diseases, oncology, autoimmune disorders, and other major therapeutic areas.

SGC001 Injection

First-in-Class Therapeutic Antibody Drug

SGC001 Injection, developed by Sungen, is a First-in-Class therapeutic antibody drug designed for the treatment of acute myocardial infarction (AMI). Its target was discovered by the research team of Professor Du Jie and Professor Li Yulin at Beijing Institute of Heart, Lung and Blood Vessel Diseases, Capital Medical University, and successfully translated into drug development by the R&D team led by Professor Sun Zhiwei at Sungen Biomed. The first clinical study was completed in Chinese hospitals.

In 2024, the SGC001 Injection program received dual IND approvals from both the U.S. FDA and China's NMPA. In 2025, it was granted Fast Track designation by the U.S. FDA. Phase II clinical research has been initiated with the first patient successfully enrolled and dosed. The program has been included in multiple science and technology innovation support programs, with its clinical value and innovative potential widely recognized by various parties. Currently, no antibody drug has been approved for AMI — SGC001 Injection is poised to fill this unmet medical need.

The SGC001 Injection program has recently filed an additional IND for the anticipated indication of severe acute pancreatitis (SAP), marking a significant step forward into multi-indication clinical development.

Development Timeline

2024
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2025
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2026
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SGT003 Injection

A Novel Bispecific Antibody Candidate

SGT003 Injection is a novel bispecific antibody candidate developed on the basis of Sungen's proprietary NexTreg™ technology platform. Its core innovation lies in the precise depletion of regulatory T cells (Tregs) within the tumor microenvironment, thereby activating anti-tumor immunity.

SGT003 Injection precisely targets tumor tissue, modulates the tumor microenvironment, and activates the body's own immune response against tumor cells. At the same time, it is designed to reduce the immune-related adverse events associated with the marketed anti-CTLA-4 antibody ipilimumab, offering a potential treatment option for a broad population of patients with solid tumors who are resistant or unresponsive to conventional therapies.

In January 2026, during the 44th J.P. Morgan Healthcare Conference, Sungen presented the preclinical results of SGT003, its oncology bispecific antibody candidate, for the first time.

The Investigational New Drug (IND) application for SGT003 Injection, Sungen's next-generation cornerstone cancer immunotherapy candidate, was approved by NMPA in June 2026.