HEFEI, China, Jul. 17, 2026 – Hefei TG ImmunoPharma Co., Ltd. (TG ImmunoPharma) announced today that its in-house developed T-cell engager (TCE) antibody candidate (project code: TGI-10) has received investigational new drug (IND) clearance from the U.S. Food and Drug Administration (FDA). To date, TG ImmunoPharma has secured clinical trial clearances in both China and the United States for three innovative candidates: TGI-2, TGI-5, and TGI-6. TGI-10 represents the company's fourth proprietary asset to receive IND clearance from the U.S. FDA.

TGI-10, an in-house developed, potential global first-in-class TCE antibody candidate, engages T-cell-mediated anti-tumor immune responses by simultaneously binding to tumor-associated antigens on the tumor cell surface and CD3 molecules on the T-cell surface. Developed on TG ImmunoPharma's proprietary pH-selective conditional activation TCE platform, TGI-10 attenuates drug activity within the systemic circulation and normal tissues while enhancing it within the localized tumor microenvironment, thereby widening the therapeutic window and improving both safety and therapeutic efficacy.

As a TCE candidate directed against a novel therapeutic target, TGI-10 exhibits favorable developability, robust oncologic efficacy, and manageable safety profiles. It is intended primarily for the treatment of solid tumors, including, but not limited to, non-small cell lung cancer, gastrointestinal tumors, gynecologic tumors, and hepatocellular carcinoma. Preclinical studies demonstrated that the antibody achieved complete tumor clearance across multiple cancer types, confirming its potent anti-tumor activity. Furthermore, the antibody exhibited an excellent safety  profile in non-human primate toxicology studies.

"TGI-10 is our fourth in-house developed candidate to receive IND clearance from the FDA, which further reinforces our confidence in our proprietary de novo discovery capabilities," said Professor Zhigang Tian, Founder of TG ImmunoPharma. "With TGI-10 entering clinical development, our innovative pipeline now spans multiple novel immune targets. Moreover, this pipeline candidate widens the therapeutic window and enhances TCE developability by utilizing our proprietary pH-selective TCE platform. Moving forward, we will continue to deepen our strategic layout in immuno-oncology, accelerate the progression of more pipelines into clinical stage, and actively explore international collaborations. We are committed to bringing more novel, high-quality first-in-class therapeutics to the global stage as early as possible to provide safe, effective, and accessible treatment options for patients worldwide."

About TG ImmunoPharma

TG ImmunoPharma is a clinical-stage biotechnology company founded by a research and development team led by Professor Zhigang Tian, an internationally renowned immunologist from the University of Science and Technology of China. The team has dedicated over 30 years to anti-tumor immunology research. Over the past decade, leveraging the mechanisms of human cancer immunity, the team has focused on identifying novel immuno-oncology targets and developing antibody-based immunotherapies. TG ImmunoPharma is dedicated to source innovation in the discovery, development, and commercialization of immunotherapies, striving to establish a globally leading immuno-oncology R&D hub and fostering a thriving innovative biopharmaceutical ecosystem.

TG ImmunoPharma has independently developed proprietary technology platforms, including the ABC-NKer^® platform, NKR-Explorer platform, and pH-selective TCE platform. Relying on these proprietary platforms, the company has constructed a highly competitive, multi-layered novel drug R&D pipeline. Currently, the company holds over 10 potential global first-in-class or best-in-class pipeline products, among which three candidates have received clinical trial clearances in both China and the United States, and one candidate has received IND clearance from the U.S. FDA. Multiple candidates are currently undergoing clinical trials in collaboration with institutions such as Peking University Cancer Hospital and Fudan University Shanghai Cancer Center, demonstrating encouraging safety profiles.

TG ImmunoPharma has been awarded numerous recognitions, including "China's Top 500 Hidden Unicorn Companies," "2026 Top 100 Chinese Pharmaceutical Innovative Enterprises," and "China Future Healthcare Rankings 2026 - Top 100 Innovative Biopharmaceutical Companies." 

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