About Grit Bio

Grit Bio is a globally leading innovator in next-generation T-cell therapies. Focused on cancer and autoimmune diseases, the Company is committed to advancing the development of globally competitive, innovative cell therapy products.

The Company is led by its founder, Chairperson and Chief Executive Officer, Dr. Yarong Liu. The Company has more than 200 employees and an R&D team of more than 100 professionals with global backgrounds. Core management team brings end-to-end experience across early-stage research, clinical translation, development & registration, and product commercialization of cell and gene therapy in China and the United States. With our highly capable team, a solid foundation for continued and global development of the Company’s innovative products has been laid.

The Company has built a diversified pipeline spanning TIL therapies, CAR-iNKT cell therapy, in vivo CAR-T cell therapies and a neoantigen tumor vaccine, addressing major unmet medical needs in solid tumors, hematologic malignancies and autoimmune diseases.

Leveraging its core capabilities in T-cell biology and engineering, the Company is advancing autologous cell therapy, engineered cell therapy, off-the-shelf allogeneic cell therapy and in vivo T-cell engineering, creating a T-cell therapy portfolio that spans a broad range of clinical settings and complementary technologies.

Grit Bio is one of the earliest innovators in China to systematically develop TIL therapies and advance them into registrational clinical development. Its TIL portfolio spans multiple generations, from non-gene-modified TIL therapy to cytokine-armored and gene-edited TIL therapies.

GT101, Grit Bio’s Core Product, is the first TIL therapy approved for clinical trial in China. GT101 is currently in an ongoing pivotal Phase II trial in cervical cancer, and is being further developed across multiple solid-tumor indications and combination-treatment settings.

Building on GT101, GritBio has developed GT201, an autologous TIL therapy expressing membrane-bound IL-15, and GT307, a double-knockout autologous TIL therapy. GT201 is designed to enhance the persistence and anti-tumor activity of TIL cells and has received IND approvals in China and the United States for clinical development, expanding the potential of engineered TIL therapies in solid tumors.

Beyond conventional ex vivo cell therapy, the Company is developing in vivo CAR-T and other in vivo T-cell engineering approaches designed to engineer T cells directly in patients.

GT801 is a next-generation, mRNA-based in vivo CAR-T therapy designed to directly convert a patient’s own T cells into CAR-T cells within the body. It uses T-cell-targeted lipid nanoparticles to deliver mRNA encoding a CAR into T cells in vivo. An investigator-initiated trial of GT801 is ongoing, with clinical exploration in hematologic malignancies and autoimmune diseases.

By continuing to develop non-viral delivery and other in vivo T-cell engineering approaches, the Company is exploring next-generation treatment paradigms that could simplify cell-therapy workflows and improve accessibility and scalability.

With its Beijing headquarters and R&D center serving as the strategic hub for operations and innovation, GritBio links its Shanghai R&D center and Suzhou GMP manufacturing base to form an integrated drug-development and industrialization system spanning drug discovery, process development, quality control, clinical translation and commercial-scale manufacturing. Its QA/QC quality management system and manufacturing facilities support end-to-end quality control from production through final product release. The Suzhou facility is ISO 9001:2015 certified and operates in accordance with applicable GMP standards, providing CMC and manufacturing support for the global clinical development and potential future commercialization of innovative T-cell therapies.

Leveraging its R&D and industrialization infrastructure in China, together with overseas clinical-development and collaboration resources, the Company continues to advance the global clinical development of its proprietary T-cell therapies.

The Company has established clinical-development and regulatory capabilities in China and the United States. Multiple internally developed programs have entered clinical stage, generating an expanding body of clinical data.

GT101 is in pivotal clinical development. GT201 has received IND approvals in China and the United States and is in Phase I clinical development. An investigator-initiated trial of GT801 is ongoing and has generated early human pharmacokinetic and pharmacodynamic data.

As GritBio advances its conventional TIL, engineered TIL and in vivo CAR-T programs through clinical trials and investigator-initiated human studies, the Company will continue pursuing global development of its innovative product candidates, seeking new advances for patients with cancer and autoimmune diseases.

GritBio has established capabilities spanning clinical development, regulatory submissions and program management in China and the United States, and continues to enhance its clinical-trial quality management system in accordance with applicable regulatory requirements and ICH GCP.

Supported by its R&D and clinical-development teams in China and the United States, the Company has end-to-end capabilities spanning clinical protocol design, IND submissions, clinical operations and quality management, global multicenter development and regulatory-strategy planning, providing a foundation for the global clinical development and industrialization of innovative T-cell therapies.