Gracell Biotechnologies Secures Two National Science and Technology Major Projects for Innovative Drug Development in 2025

Recently, Grit Bio announced that two innovative products independently developed by the company — Tumor Infiltrating Lymphocyte (TIL) therapy and an off-the-shelf cellular therapy product — have been successively approved for inclusion in national science and technology major projects for innovative drug development. This marks a high level of national recognition for the company's research capabilities and strategic direction.

The National Science and Technology Major Project for Innovative Drugs aims to focus on China's strategic needs, centering on the creation of significant new drug varieties and overcoming core key technologies. The two innovative products approved this time by Grail Bio precisely address the two major core challenges and future directions in the current field of cell therapy.

Project 1: Development of Novel Drugs for Immune Cell Therapy in Solid Tumors

Focus of the Topic:In response to the global challenges of high heterogeneity in solid tumors, tumor immune tolerance microenvironment, and the difficulty of immune cells effectively infiltrating into the tumor core, Grail Bio will focus on these issues as strategic research objectives. The company is committed to overcoming key core technologies that enhance the efficient infiltration, long-term persistence, and precise killing functions of TIL therapy in solid tumors. Grail Bio aims to develop a new generation of immunotherapy drugs with strong infiltration, prolonged persistence, and significant efficacy, supporting China's core strategic goal of improving the treatment outcomes of malignant tumors and addressing major clinical needs.

Special Project 2Universal Cell Therapy Product Development

Focus of the Topic:Traditional autologous immune cell therapy faces industrial bottlenecks such as long cycles, high costs, and complex individualized preparation. The development of universal cell therapy products has become the pinnacle of global biopharmaceutical competition. However, the industry still confronts core challenges like immune rejection (GvHD/HvGR), insufficient durability of efficacy, and stability in scaled production. Grail Bio is committed to developing "off-the-shelf" universal cell therapy products that require no matching and are ready for immediate use. Through disruptive technologies, the company aims to standardize and scale the production of cellular medicines, creating a world-class universal cell preparation platform. This endeavor represents a cutting-edge technological challenge on a global scale and serves as a vital mission to reduce healthcare burdens, enhance the accessibility of high-value innovative drugs, and benefit a wide range of patients. It also provides strategic support for building an independently controlled cell therapy industrial ecosystem in China.

The two special projects are like two wings, reflecting Grail Bio's dual-driven strategy of "rooted in cutting-edge science and oriented towards national needs." Since its establishment, Grail Bio has set a development path driven by profound scientific insights to foster original innovation. The company has gathered research and industry elites from top global institutions, building an all-encompassing R&D platform covering new target screening for T-cell immune regulation, efficient cell expansion processes, engineering modifications, and clinical translation studies. Relying on its proprietary technologies including the StemTexp® dry TIL expansion technology, the high-throughput TCR discovery platform TST hunter®, the immune modulation target screening platform ImmuT Finder®, the efficient TIL gene knockout system KOReTIL®, and the stable production cell line platform StaViral®, the team has formed a complete technical closed loop from target identification to scaled preparation in TIL and next-generation cell therapy drug development, demonstrating solid immunological expertise and strong capabilities in transforming research into applications.

In the field of TIL therapy, Gracell Biotechnologies not only focuses on the process optimization and expansion technology of traditional TIL therapy but also emphasizes the development of next-generation enhanced TIL products. Using its proprietary dry TIL expansion technology, StemTexp®, the company can rapidly expand cells to clinical infusion doses within approximately 22 days and specifically amplify memory T cells for better clinical efficacy. By employing gene engineering methods such as the immune modulation target screening platform ImmuT Finder® and the highly efficient TIL gene knockout system KOReTIL®, TILs are endowed with stronger anti-tumor activity and persistence to address core challenges like the suppression of the solid tumor microenvironment. This major special project support will accelerate the clinical breakthroughs of its TIL pipeline in highly prevalent solid tumors in China, including cervical cancer, non-small cell lung cancer, head and neck cancer, ovarian cancer, and gastrointestinal tumors.

In the field of universal "off-the-shelf" cell therapy, Grit Biotechnology has taken a forward-looking approach, focusing on the development of "ready-to-use" cell drugs that do not require matching and can be used immediately. The company addresses two major global challenges in allogeneic cell therapy—graft-versus-host disease (GvHD) and host rejection—through disruptive and innovative technologies. At the same time, the company has established advanced large-scale, automated manufacturing processes, laying a solid foundation for cost control and stable supply of future products. The advancement of this initiative will greatly accelerate China's industrialization process in the global arena of universal cell therapy.

National Science and Technology Major Project for Innovative Drug Development

The National Science and Technology Major Project for Innovative Drug Development is closely aligned with the Healthy China strategy. It aims to achieve a strategic leap in drug research from imitation to original innovation. Under the conditions of a socialist market economy, it focuses on overcoming key core technologies, strengthening original and independent innovation at the source, proposing major original theories, breaking through underlying key core technologies, and conducting integrated research around the creation of significant new drug varieties and the construction of an innovation system.

Grit Bio was founded in 2019 as an innovative pharmaceutical company focused on immunotherapy, with research pipelines represented by TIL (Tumor-Infiltrating Lymphocyte) therapy and off-the-shelf cell therapy. Grit Bio has completed multiple rounds of equity financing, receiving support from several well-known domestic and international venture capital funds. The GT101 injection, independently developed by Grit Bio, is the first TIL drug in China to be approved for clinical registration and is currently in a pivotal Phase II clinical trial. Grit Bio's GT201 injection, the world’s first membrane-bound IL-15 complex-engineered TIL product, has completed dual IND submissions in both China and the United States. The company’s core R&D platforms include the StemTexp® TIL expansion technology platform, StaViral® stable viral production process, ImmuT Finder® immune modulation target discovery platform, and KOReTIL® high-efficiency gene knockout system, based on which a series of next-generation gene-edited TIL drugs have been developed. Additionally, Grit Bio has deep technological expertise in delivery systems and AI-driven neoantigen discovery. With internationally leading technical reserves and industrial resources, Grit Bio aims to develop groundbreaking cell therapies to bring new hope to cancer patients and those suffering from other diseases.