HuaDao Bio Submits NDA for First-in-Class CAR-T Therapy Priced at Just Over RMB 200,000
Huadao Biopharma
Developer and Manufacturer of Cell-Based Immunotherapy Drugs
December 12, 2025
eMedClub News
Today, HuaDao CAR-Tcell revealed that it has submitted to the Center for Drug Evaluation of the National Medical Products Administration.（CDE）Submitted its first product targetingRefractory and Relapsed Non-Hodgkin LymphomaThe marketing application of the CAR-T cell drug. Particularly noteworthy is that this "Made in China" cell drug, which has complete independent intellectual property rights, onlyRMB 200,000+。
It is speculated that the candidate drug is HD CD19 CAR-T.(Subject to the company's disclosure), which has been approved for two clinical indications, including the treatment of refractory or relapsed non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia. It uses replication-defective lentiviral transduction of autologous T cells to express a CAR structure that specifically binds to the CD19 antigen, enabling CAR-T cells to effectively eliminate CD19-positive tumor cells, thereby achieving therapeutic effects against tumors.
HuaDao CAR-Tcell insists on developing affordable cell drugs for the public, and remains committed to drug research and development alongside independent innovation across the entire industrial chain. The company's core competitiveness lies in its "full-industry-chain independent innovation" and "industrialized production model."
In 2023, the company's fully self-developed key industrial technologies and equipment for CAR-T cells officially passed the CDE’s associated review, making it the only enterprise in China at that time to possess full independent intellectual property rights across the entire CAR-T cell industry chain, completely eliminating the risks of being constrained by critical technologies and supply chains.
At the same time, the company has increased the production capacity of cell drugs to traditional methods through its self-developed fully automatic, fully enclosed, unmanned production system.50 times or moreAccording to reports, the personalized CAR-T cell drug fully automatic, fully enclosed, unmanned production base currently being constructed by HuaDao CAR-Tcell in Xiaokunshan Town, Songjiang District, will have an initial annual production capacity of...9000 people/dose`, far exceeding the current annual production capacity of less than 300 units per year for products already on the market in China.`
In addition to the product submitted this time, HuaDao CAR-Tcell has four other cell drugs for different cancer types in Phase Ⅰ-Ⅱ clinical trials, continuously expanding its innovative layout in the field of tumor immunotherapy.
Recommended Reading:HuaDao CAR-Tcell's Second Solid Tumor CAR-T Approved for Clinical Trials, Aiming to Break the Accessibility Barrier of Expensive CAR-T Therapy
Editorial Responsibility | Ju
Proofread by Ju Chrysanthemum
References:
1. HuaDao CAR-Tcell Official WeChat
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