Huadao Biotech achieves breakthrough with first solid tumor CAR-T therapy

Huadao (Shanghai) Biopharmaceutical Co Ltd has announced a major advancement in immunotherapy with the approval of its first CAR-T cell therapy for solid tumors. The therapy, HD004, is the world's first cellular treatment targeting CLDN18.2-positive advanced solid tumor malignant ascites, marking a significant step towards making CAR-T therapies more accessible in China.

CAR-T cell therapy, a groundbreaking cancer treatment, involves collecting a patient's T cells, genetically modifying them to target specific cancer cells, expanding them in the lab and re-infusing them to fight the tumor. Unlike traditional treatments like surgery or radiation, CAR-T therapy offers a more personalized approach to cancer care.

"This approval is a milestone for Huadao Biotech, as HD004 becomes the company's first CAR-T candidate for solid tumor treatment," said Yu Xuejun, chairman of Huadao Biotech. CLDN18.2, the target for HD004, is highly expressed in certain cancers, including gastric and esophageal cancers, and is associated with poor prognosis. Malignant ascites, a severe complication of advanced tumors, affects 15 percent to 50 percent of patients with late-stage cancers, often leaving them with a median survival of just five to seven months.

The company has also received approval from China's National Medical Products Administration for three additional CAR-T candidates targeting B-cell non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia and multiple myeloma.

One of the key challenges facing CAR-T therapies is their high cost. Yu, a physician with extensive clinical experience, is focused on reducing these costs through innovation. In June 2023, Huadao Biotech received approval for its fully automated cell culture system, a first in China. The company claims this domestically produced equipment can lower production costs by up to 70 percent compared to imported alternatives.

"Our goal is to make CAR-T therapies affordable for the Chinese public," Yu said.