Gracell Biotechnologies Honored as 'Most Influential Innovative Therapy Company in CGT Asia 2025'

RecentlyCGT Asia 2025, the 8th Asian Cell and Gene Therapy Innovation Summit hosted by Tansi Bio, grandly opened in Shanghai. At the concurrently held 2025 3rd Asia-Pacific Cell and Gene Therapy Industry Star Awards Ceremony, Grail Bio was honored as the "Most Influential Innovative Therapy Company of 2025" due to its innovative breakthroughs and advancements in the field of cell therapy.

Since its establishment in 2019, Grail Biotechnology has consistently focused on the unmet needs in solid tumor treatment, with its core product...GT101 InjectionAs the first TIL drug in China to be approved for registered clinical trials, it has entered the pivotal Phase II clinical trial stage, offering a breakthrough treatment option for patients with advanced solid tumors. In 2024, the national investigator meeting for GT101's Phase II clinical trial was successfully held. In the same year, the first subject completed the infusion with good safety and significant efficacy.EurekAlert, the global science news service hosted by the American Association for the Advancement of Science (AAAS), reported the latest clinical findings of Grit Bio's TIL product GT101. The research results were published in the form of a paper in the journal *Molecular Biomedicine*.

Based on an internationally leading innovation platform, Grit Bio simultaneously deploysWorld's First Next-Generation TIL Product Development, Gravel Biotech's self-developedGene-Edited TIL Product GT201Equally impressive performance.Since 2024, it has successively received dual IND approvals from the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). Its research data has drawn widespread attention at international academic conferences such as the 2024 U.S. TIL Therapies Summit, making it the world's first gene-edited TIL candidate drug to enter the dual China-U.S. regulatory pathway.

At the same time, the world's first CRISPRThe GT3 series of dual-target gene-edited TIL injection demonstrated good safety and clinical efficacy in several patients with advanced solid tumors, with related findings presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Grit Biotech in 2025Milestone Progress Achieved in Tumor Vaccine Pipeline DevelopmentBased on the independently developed NEOvigator™ neoantigen discovery platform, the company has successfully constructed an mRNA tumor vaccine system with high immunogenicity characteristics, which is delivered by a targeting system to achieve optimal immune activation and therapeutic effects.The relevant research achievements will make consecutive appearances at two major authoritative conferences worldwide in 2025 — the American Association for Cancer Research (AACR) Annual Meeting and the International Neoantigen Summit.

In the future, the company will continue to accelerate the global commercialization process of its products, committing to developing groundbreaking cell therapies for patients worldwide.

"This award is not only an affirmation of the Grail Bio team, but also recognition of the value of TIL therapy in the treatment of solid tumors," said Dr. Yarong Liu, founder and CEO of Grail Bio. "We will continue to focus on the field of cell therapy, with patient needs at the core, promoting the global clinical development of products such as GT101 and GT201, so that more innovative therapies can benefit cancer patients in China, the Asia-Pacific region, and globally."

The professional review panel combined the comprehensive performance of the applying enterprises in selection dimensions such as capital value, growth speed, and development prospects. After processes of data compilation and verification, research analysis, and investigative interviews with the applying enterprises, the panel ultimately selected the "2024 CYZONE Top 100 Future Unicorns."

Progress of Grail Bio's R&D Pipeline Reported

• Grit Bio's Neoantigen Vaccine to Debut at International Summit in March 2025, Clinical Research to Commence

• Report on Grail Bio's TIL Product GT101 Clinical Findings in December 2024

• EurekAlert, the global science news service platform hosted by the American Association for the Advancement of Science (AAAS), reported the latest clinical findings titled **"T cell receptor repertoire characteristics and therapeutic potential of tumor infiltrating lymphocytes (TILs) derived from metastatic lymph node in cervical cancer"** (published in *Molecular Biomedicine*), which were authored by the research team of Grit Bio in collaboration with the leading contribution of the Biological Cell Therapy Center of the First Affiliated Hospital of Zhengzhou University.

• At the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held in Houston, USA, in 2024, Grail Biotechnology participated in this conference to share the results of a collaborative project with Professor Zhao Bing's team from the State Key Laboratory of Genetic Engineering and the School of Life Sciences at Fudan University: the application of patient-derived autologous organoids (PDO) to enrich tumor-specific tumor-infiltrating lymphocytes (TIL).

• At the 2024 TIL Therapies Summit, share the potential and opportunities of tumor-infiltrating lymphocyte (TIL) therapy in achieving breakthroughs across more indications through expert panel discussions and keynote speeches, and showcase the company's R&D progress and clinical trial results for next-generation gene-edited TIL products.

• At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, a series of latest research findings in the field of cell therapy were announced: Phase I clinical data for the TIL injection GT101 showed good safety and clinical efficacy in multiple patients with advanced solid tumors; the latest Phase I clinical data for GT201, the world’s first membrane-bound IL-15 complex-edited TIL injection, also demonstrated good safety and clinical efficacy in several patients with advanced solid tumors; and GT316, the world's first CRISPR dual-target gene-edited TIL injection, showed good safety and clinical efficacy in multiple patients with advanced solid tumors.

• At the 2024 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), a series of latest research achievements in the field of cell therapy were announced: The high-throughput CRISPR screening platform ImmuT Finder® facilitated the discovery of key immune regulatory targets in NK cells, the latest preclinical and clinical data of the dual-knockout TIL product GT316 with anti-exhaustion capabilities, and the latest research results from external collaboration projects: identification of novel antigen-presenting cell-targeting LNP for mRNA tumor vaccine development.

• At the 2024 American Association for Cancer Research (AACR) Annual Meeting, two latest research achievements in the TIL (Tumor-Infiltrating Lymphocytes) field were announced: GT216, a novel gene-edited TIL product enhancing efficacy in solid tumors, and the latest data on GT307, the next-generation dual-knockout TIL product based on the high-throughput CRISPR screening platform ImmuT Finder®.

• At the 2023 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), the company comprehensively showcased its screening achievements of tumor-reactive biomarkers during the TIL in vitro expansion phase.

• At the 2023 TIL Therapies Summit, the company announced the latest preclinical and clinical trial results of its high-throughput CRISPR screening platform, ImmuT Finder®, and the next-generation double-knockout TIL product, GT316, developed based on this platform.

• At the 2023 American Association for Cancer Research (AACR) Annual Meeting, the company announced its high-throughput CRISPR screening platform ImmuT Finder® and the preclinical research of the next-generation double-knockout TIL product GT316 developed based on this platform.

• At the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, the company announced the clinical trial progress of its GT201 product. GT201 demonstrated stable expansion capability and showed good safety and preliminary clinical efficacy in multiple patients with advanced solid tumors.

• At the 2023 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), the company presented preclinical research findings on its next-generation gene-edited TIL product, GT201. By employing a customized retroviral system designed for engineered TIL therapy, GT201 achieved stable expression and functional enhancement across multiple batches of TIL cells derived from various tumor types.

• At the 2022 American Association for Cancer Research (AACR) Annual Meeting, the company unveiled the technical highlights of its proprietary TIL stemness expansion platform, StemTexp®, as well as the next-generation TIL product GT202, developed based on the viral process platform StaViral®.