Huida Bio Announces First-in-Class CLDN18.2-Targeted CAR-T Therapy HD004 Granted IND Approval for Malignant Ascites in Advanced Solid Tumors
Huadao Biopharma
Developer and Manufacturer of Cell-Based Immunotherapy Drugs
Recently, HD004 cells, independently developed by HuaDao CAR-Tcell (Shanghai) Biomedical Co., Ltd. ("HuaDao Biomedical"), received clinical trial tacit approval from the CDE.It is reported that HD004 is not only the fourth CAR-T cell therapy pipeline submitted by HuaDao CAR-Tcell, but alsoHuaDao CAR-Tcell's First Cell Therapy Candidate for Solid Tumor Treatment, and it is also the world's first targeted therapy for CLDN18.2-positive expression.Treatment of Malignant Ascites in Advanced Solid TumorsThe First CellTherapeutic Candidate Drug。
Claudin18.2（CLDN18.2) belongs to the CLDN family of tight junction proteins, produced byCLDN18Gene coding.CLDN18.2It is a transmembrane protein, containing 4 transmembrane domains and 2 extracellular loops.
▲ Claudin18.2 is a transmembrane protein.
Proteins in the Claudin (CLDN) family play a crucial role in maintaining normal tight junctions between cells. They have four transmembrane domains and are involved in regulating the permeability and conductivity between cells. Among them, CLDN18.2 is highly expressed in gastrointestinal cancers such as gastric cancer, making it a highly promising therapeutic target for treating solid tumors like gastric cancer and pancreatic cancer.
CLDN18.2The high expression is associated with the occurrence, development, metastasis, and prognosis of cancer. Its high expression not only activates signaling pathways such as PI3K/Akt and MAPK, promoting the proliferation of tumor cells, but also alters the adhesion and plasticity of tumor cells, enhancing their ability to metastasize and invade, and increasing the malignancy of tumors.
HuaDao CAR-Tcell was established in 2017. With the mission of "making cell drugs affordable for the Chinese people," the company adheres to a dual innovation path across the entire industry chain, focusing on "cell drug research and development + key equipment and technological breakthroughs for industrialization" with independent intellectual property rights. After six years of development, the company has overcome key production equipment for cell (CAR-T) preparation, supporting single-use consumables, intelligent cell (CAR-T) liquid nitrogen cold chain transportation, and other critical equipment and bottleneck technologies for cell (CAR-T) industrialization. It has become a national high-tech enterprise in China's cellular immunotherapy field, owning independent intellectual property rights for key equipment, reagents, and consumables across the entire industry chain.
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