Maoxing Bio's Allogeneic CAR-T Therapy MT027 Receives FDA Approval for Phase II Clinical Trial in Recurrent Glioblastoma

Recently, Suzhou Maoxing Biotechnology Co., Ltd. officially announced that its self-developed universal CAR-T cell therapy MT027 targeting B7H3 has received approval from the U.S. Food and Drug Administration (FDA).（FDA）Approved for Phase II Clinical Study to Treat Recurrent Glioblastoma（rGBM）. This approval marks a substantial breakthrough for Suzhou Maoxing Biotechnology Co., Ltd. in overcoming the global challenge of allogeneic CAR-T therapy for solid tumors.

"The FDA's approval of MT027 Phase II clinical trial is an important affirmation of our team's strategy focusing on the most difficult-to-treat solid tumors."」Founder and CEO of Suzhou Maoxing Biotechnology Co., Ltd. stated,「This is not only a small step for Maohang, but also a big step for the entire cell therapy industry in exploring the 'uncharted territory' of solid tumors. The successful development and advancement of MT027 is due to our deep understanding of immunology and decisive investment in cutting-edge allogeneic cell editing technology.As a technology-driven enterprise, Suzhou Maoxing Biotechnology Co., Ltd. will continue to uphold a rigorous and pragmatic scientific attitude, steadily advancing the registration clinical research of MT027, and continuously exploring the uncharted territory of solid tumor cell therapy. With the power of science, we strive to buy more time for life.」

MT027 is a product derived from healthy donors.「"Off-the-Shelf" B7H3-Targeted UCAR-T Cell Therapy Product for the Treatment of Recurrent Glioblastoma（rGBM）MT027 as a「"Spot Type"（Off-the-shelf）Products that can achieve scale production and cryopreservation allow patients to receive treatment immediately after diagnosis without waiting, saving precious treatment time to save lives.

Unlike the commonly used lentiviral or retroviral vectors in the industry, MT027 has achieved a highly forward-looking technological leap in the critical phase toward registration for clinical trials — fully establishing and locking in a non-viral gene editing process. This advancement further enhances product safety while improving the precision and controllability of the preparation process, representing the future direction of next-generation cell therapy technology.

CAR-T therapy has been successful in hematologic malignancies but has progressed slowly in the field of solid tumors, especially against glioblastoma, which features a blood-brain barrier, high heterogeneity, and an immunosuppressive microenvironment.「Fortress」The approval of MT027's IND marks a milestone in the advancement of universal CAR-T technology into the most challenging field of solid tumors.

It is reported that, relying on the company's mature general technology platform, Suzhou Maoxing Biotechnology Co., Ltd. is simultaneously advancing clinical research targeting multiple brain metastasis tumors and other solid tumors, continuously expanding its product portfolio.

Glioblastoma（GBM）Because of its extremely strong invasiveness, extremely poor prognosis, and high recurrence rate, it is known as「Mount Everest」. Despite the existing standard treatment options(Stupp regimen)Has been widely used, but the median survival time for patients is still only 14-16 months, with a five-year survival rate of less than 5%. For recurrent gliomas（rGBM）For patients, treatment options are even more limited, with a median survival period of less than 6-9 months after recurrence, indicating that clinical needs are far from being met.

Since its establishment, Suzhou Maoxing Biotechnology Co., Ltd. has been committed to「Addressing Unmet Clinical Needs」With a core focus on research and development, avoiding the crowded field of hematological tumors, and directly addressing the stubborn disease of glioma. This breakthrough fully validates the feasibility of Suzhou Maoxing Biotechnology Co., Ltd.'s technology platform.

Suzhou Maoxing Biotechnology Co., Ltd. is an innovative enterprise focused on the development of universal cell therapies, dedicated to addressing the challenge of "untreatable" diseases through cellular therapies. The company has gathered a seasoned team from the fields of immunotherapy, gene editing, and biopharmaceutical industrialization. Leveraging its proprietary gene-edited allogeneic immune cell platform, it has successfully overcome issues of graft-versus-host disease and immune rejection in allogeneic cell therapy, enabling CAR-T cells to achieve long-term persistence and efficacy in patients. The company is currently concentrating on advanced malignant tumors, with its first product pipeline for recurrent glioma having been approved to enter Phase II clinical trials.

The company plans to advance at least one product to market within the next three years and push multiple products into Phase II clinical trials. Suzhou Maoxing Biotechnology Co., Ltd. adheres to the principles of "upholding integrity, innovating quietly yet profoundly, and promoting synergy and integration." The company remains committed to clinical value as its guiding principle, focusing on advancing innovation in the field of solid tumor cell therapy, with a dedication to true original innovation. It aims to provide new hope for diseases that currently lack effective treatment options.

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