Recently, the clinical trial application for HD006 CAR-T Cell Injection, independently developed by HuaDao CAR-Tcell (Shanghai) Biomedical Co., Ltd. ("HuaDao Biomedical" for short), has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.This product is the fifth CAR-T cell therapy product submitted by HuaDao CAR-Tcell's accessible cell drug intelligent manufacturing shared technology platform. It is intended for the treatment of patients with advanced solid tumors that are GUCY2C-positive, aiming to improve the quality of life and prognosis for patients with advanced solid tumors, providing a new treatment option for patients in this field.
CAR-T products for the treatment of solid tumor masses have faced 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 a molecular marker highly expressed in various gastrointestinal tumors such as colorectal cancer, gastric cancer, esophageal cancer, and pancreatic cancer. It shows particularly stable expression in liver metastases of colorectal cancer. Globally, there are already multiple tumor vaccines, bispecific antibodies, and other therapies targeting GUCY2C.ADC DrugsEnter the clinical research stage，HD006CAR-T Cell Injection is a clinical trial drug for the treatment of patients with advanced solid tumors who are GUCY2C-positive, have failed at least one standard anti-tumor systemic treatment, are not suitable for standard systemic treatment, or have no standard systemic treatment available. It works by genetically modifying the patient’s autologous T cells to express a CAR structure capable of recognizing GUCY2C, which allows the T cells to specifically identify and attack GUCY2C-positive tumor cells, exerting an anti-tumor effect and providing a new treatment option for patients.HD00HD006 is HuaDao CAR-Tcell's second solid tumor cell therapy following the HD004 solid tumor CAR-T therapy. 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，Meeting the needs of advanced solid tumors with malignant ascitesThe treatment needs of patients with cavity effusion are in line with the "Guiding Principles for Clinical Development of Anti-Tumor Drugs Oriented by Clinical Value" issued by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.Significantly 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, established in September 2017 in Zhangjiang Hi-Tech Park, Shanghai, is a national high-tech biopharmaceutical enterprise dedicated to the mission of "making CAR-T cell drugs affordable for the general public." The company focuses on the development and production of cellular immunotherapy drugs and the entire industry chain's supporting production technologies (equipment and consumables). As a leader in China’s CAR-T field, it owns a complete set of proprietary technologies for the whole industrial chain, striving to become a pioneer in the independent innovation and application of CAR-T cell technology across the entire industry chain.Currently, HuaDao CAR-Tcell has base constructions in many places in China.
In order to allow everyone to learn and communicate with each other better,"WeChat Official Account 'Cell Gene Therapy' Team"A WeChat group for cell therapy and gene therapy discussions has been established. Interested friends can scan the QR code below to add the editor's WeChat and join the cell therapy and gene therapy discussion group.。Article Recommendation (Click on the article title below to open the original):
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