HEFEI, China, Aug. 6th, 2025 – TG ImmunoPharma(TGI), a clinical-stage biotechnology company advancing new immune checkpoint inhibitors, NK/T-cell engagers, and immunocytokines, today announced that the first patient has been successfully dosed in its Phase 1 trial of TGI-5, one of company’s leading assets targeting CD155, in Fudan University Shanghai Cancer Center.

TGI-5 is the world’s second and China’s first anti-CD155 antibody to enter clinical development. Preclinical studies have shown that it simultaneously restores NK and T cell anti-tumor function and exhibits strong efficacy across solid tumor animal models. Currently, apart from TGI-5, only one candidate targeting CD155 is in Phase 1 trials globally.

TGI-5 is a novel, proprietary immune checkpoint inhibitor developed by TG ImmuoPharma. The first-in-human, open-label, single-arm Phase 1 study (TGI5-T1-02) will enroll patients with unresectable locally advanced or metastatic solid tumors to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and anti-tumor activity of TGI-5. Notably, TGI-5 synergizes with PD-1 blockade, offering a "1+1>2" combination strategy for advanced tumors. 

"TGI-5 is China's first anti-CD155 monoclonal antibody to enter clinical development." said Dr. Haoyu Sun, Chief Executive Officer of TGI. "As a key pipeline candidate, it holds potential for treating multiple tumor types and offers new options for combination strategies. We aim to rigorously validate its clinical value to bring new hope to patients with advanced solid tumors. TGI also looks forward to collaborating broadly with biopharma companies and investors worldwide to accelerate patient benefit."

Dr. Zhigang Tian, founder of TGI, said, "With the first patient enrolled for TGI-5, TGI now has two potential ‘best-in-class' drugs in clinical trials in China, delivering more innovative 'Made in China' therapies to cancer patients worldwide. Guided by 'Science First, Life Foremost,' we are breaking foreign monopolies through original innovation. The launch of TGI-5’s clinical trial marks a key milestone for TGI and reflects China’s ability in novel innovation. Together with researchers and clinicians, we are committed to addressing unmet needs and improving patient outcomes by advancing TGI-5’s clinical development to offer safer, more effective treatments as soon as possible."

About TGI-5

TGI-5, a novel anti-CD155 antibody independently developed by TGI. TGI-5 blocks the interaction between CD155 and CD226/TIGIT/CD96, displaying both immune checkpoint blockade function and CD226 expression restoration effects. 

About TG ImmunoPharma Co., Ltd.

TG ImmunoPharma Co., Ltd. (TGI) is a biotech company founded by the R&D team led by Dr. Zhigang Tian, a pioneer in NK cell receptor-ligand research from the University of Science and Technology of China. The company focuses on developing innovative immunotherapies.

With over 30 years of experience in NK cell research, the team has achieved global leadership in the field. Over the past decade, it has ranked first worldwide in SCI publications related to NK cell research and was among the first to discover and validate key immune checkpoints such as NKG2A and TIGIT.

TGI has independently developed transformative platforms including ABC-NKer® and pH-selective TCE, leveraging original innovation to create first-in-class or best-in-class therapies. Its pipeline comprises over ten candidates across four categories, including immune checkpoint inhibitors and bi-/multi-functional antibodies, targeting solid tumors and autoimmune diseases. Among these, three programs have received IND clearance from the FDA and NMPA. TGI-6 and TGI-5 are currently in Phase I trials in Chinese leading oncology hospitals, demonstrating favorable safety profiles.

The company operates a nearly 6,000m2 R&D base equipped with core facilities such as SPF animal lab and GMP labs. It has filed nearly 100 invention patents and has been recognized as one of “China’s Top 500 Hidden Unicorns” and “Specialized and Sophisticated Small and Medium-sized Enterprise”. TGI has raised over RMB 200 million in cumulative financing.

With a long-term commitment to innate immunity research and drug innovation, TGI engages deeply through technology transfer, licensing, and collaborations, aiming to deliver innovative drugs with proprietary IP to patients worldwide.

For more information, please visit www.tgimmunopharma.com.

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