Huadao Bio Announces IND Approval for HD006 CAR-T Cell Injection Targeting GUCY2C-Positive Solid Tumors

Jun 23, 2025 11:03 CST Updated 11:03

Huadao Biopharma

Developer and Manufacturer of Cell-Based Immunotherapy Drugs

Recently, HuaDao CAR-Tcell (Shanghai) Biomedical Co., Ltd. (hereinafter referred to as "HuaDao Biomedical") has received approval from the National Medical Products Administration (NMPA) for the clinical trial application of its self-developed HD006 CAR-T Cell Injection. This product is the fifth CAR-T cell therapy product submitted through HuaDao Biomedical's accessible cell drug intelligent manufacturing shared technology platform.Is the company's IND approvedThe Second Solid Tumor Cell Therapy，Intended for the treatment of patients with advanced solid tumors positive for GUCY2C expression, aiming to improve the quality of life and prognosis for patients with advanced solid tumors, providing new treatment options for patients in this field.

CAR-T products for the treatment of solid tumor masses face challenges such as suppression by the tumor microenvironment and target heterogeneity, making it difficult to balance safety and efficacy in clinical treatment. GUCY2C (guanylate cyclase C) is expressed in various cancers, including colorectal cancer, gastric cancer, esophageal cancer, and pancreatic cancer.Molecular markers that are highly expressed in gastrointestinal tumors, especially showing stable expression in liver metastases of colorectal cancer. Globally, there are already multiple tumor vaccines, bispecific antibodies, and other targeted therapies against GUCY2C.ADC DrugsEntering the clinical research phaseParagraph,HD006CAR-T Cell Injection is for GUCY2C-positive patients who have failed at least one standard anti-tumor systemic treatment.Clinical Trial Drug for the Treatment of Patients with Advanced Solid Tumors, Suitable for Standard Systemic Therapy or Without Standard Systemic Therapy: Through genetic modification of the patient’s autologous T cells, the T cells express a CAR structure capable of recognizing GUCY2C, which can specifically identify and attack GUCY2C-positive tumor cells to exert an anti-tumor effect. This clinical trial will be led by the Cancer Hospital of the Chinese Academy of Medical Sciences in the near future.

HD006 is HuaDao CAR-Tcell's follow-up to HD004 for solid tumor CAR-T therapy.The second solid tumor cell therapy after the law, HD004 cells are produced using HuaDao CAR-Tcell's full-industry-chain independent innovation accessible cell drug R&D and transformation platform technology.Characterized by affordable prices and future医保 affordability，It meets the treatment needs of patients with advanced solid tumors and malignant ascites, and complies with the regulations of the National Medical Products Administration.Guidelines for Clinical Development of Anti-Tumor Drugs Oriented by Clinical Value" issued by the Center for Drug Evaluation (CDE)Guiding Principles》, willSignificantly extend the life cycle and improve the quality of life for patients with such tumors, and will have a profound impact on comprehensive treatment plans and tumor management for preventing recurrence and metastasis in patients with solid tumors after surgery.。

HuaDao CAR-Tcell is a biopharmaceutical company specializing in cellular immunotherapy, with a particular focus on the technology development and innovation of the entire industrial chain for cell-based drugs. Established in September 2017 in Zhangjiang, Shanghai, the company relocated to Songjiang, Shanghai, in 2020, within the National Songjiang Economic and Technological Development Zone, the main hub of "Songjiang Creation." With the mission of "making cell-based drugs affordable for the Chinese people," the company adheres to a dual innovation path across the entire industrial chain, emphasizing "cell drug research and development + key equipment and technological breakthroughs for industrialization" based on self-owned intellectual property rights. In 2024, HuaDao CAR-Tcell will fully launch the construction of five major production bases across China, striving to become a platform-based pharmaceutical enterprise with independent research and development capabilities and production transformation capacity for cell-based drugs in China.

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