Shanghai-based Huadao Biologics Files for IPO with Promise of $30,000 CAR-T Therapy

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Recently, according toAccording to the information disclosure on the CSRC website,HuaDao CAR-Tcell (Shanghai) Biomedical Co., Ltd. (hereinafter referred to as "HuaDao")HuaDao CAR-Tcell has submitted a filing report for the initial public offering (IPO) and listing coaching to the Shanghai Securities Regulatory Bureau.The tutoring institution is Ping An Securities Co., Ltd.

This news marks HuaDao CAR-TcellThe company officially launched its capital market sprint plan.

It is worth noting that HuaDao CAR-TcellHuaDao CAR-Tcell's leading CAR-T drug has already applied for a pre-NDA communication meeting with the Center for Drug Evaluation in December 2025, and is expected to officially launch its NDA plan within this year.

During the critical regulatory period for HuaDao CAR-Tcell's first CAR-T product, HuaDao CAR-Tcell has initiated its IPO plan. IfHuaDao CAR-Tcell's successful listing will leverage the power of the capital market to rapidly advance the preparation for the launch of its CAR-T cell products in the future.

$200,000 CAR-T

Currently, internationally, CAR-T cell therapyThe price of therapy ranges from $300,000 to $500,000, while the price of CAR-T therapy in China is around $1,000,000 to $1,200,000.(Currently, the lowest price on the market is Yuan Rui Da from Heyuan Bio, priced at 999,000 yuan)。

The high cost of treatment has always been a key factor limiting patients' access to CAR-T therapy.

Against this backdrop, HuaDao CAR-TcellWu Li aims to "Affordable Cell Drugs for Chinese Common People". According to HuaDao CAR-Tcell in 2025In December, it was disclosed that its firstCAR-T for Refractory and Relapsed Non-Hodgkin LymphomaThe future selling price of cellular drugs will be only more than 200,000 yuan.

And this CAR-T cell product is currently in the preparation stage for market launch and has been submitted toThe Center for Drug Evaluation of China has applied for a pre-market application communication meeting.

If it successfully gains regulatory approval in the future, this breakthrough price will bring new changes to the CAR-T cell therapy landscape in China.

The Confidence Behind a 200,000 Yuan Price Tag

In fact, "producing CAR-T for 200,000 yuan" was not a recent proposal by HuaDao CAR-Tcell; it has been their goal since the company's establishment in 2017.Always adhering to the mission of "making cell drugs affordable for ordinary Chinese people."

In fact, the high production cost of CAR-T cell therapy in China is also a reason for the high selling price of CAR-T. A major cause of the high cost lies in the core materials.Dependent on imports,Such as lentiviral vectors, cell culture reagents, equipment, etc.

So, how does HuaDao CAR-Tcell have the confidence to announce a "200,000 RMB plus" price for CAR-T?

In 2015, before HuaDao CAR-Tcell was officially registered, founder Yu Xuejun made a highly visionary yet extremely difficult decision: to advance drug development while initiating independent innovation of core technologies across the entire industrial chain, clearing obstacles for "affordable pricing" from the outset.

In June 2023,HuaDao CAR-Tcell's Fully Independent R&D of Key Industrial Technologies and Equipment for CAR-T Cells Officially Passes the Correlation Review of the Center for Drug Evaluation (CDE). HuaDao CAR-Tcell Has Become the Only Enterprise in China with Full Intellectual Property Rights of the CAR-T Cell Industry Chain, Completely Eliminating the Risks of "Bottleneck" in Key Technologies and Supply Chains.

Developed independently by HuaDao CAR-TcellFully automatic, fully enclosed, unmanned production system. According to reports, HuaDao CAR-Tcell inThe personalized CAR-T cell drug fully automatic, fully enclosed, unmanned production base built in Xiaokunshan Town, Songjiang District, has an initial annual production capacity of 9,000 units.

It is the dual innovation of "full-chain autonomy" and "industrialized production" that underpins HuaDao CAR-Tcell's disruptive price reduction.

HuaDao CAR-Tcell's first CAR-T drug submission for market approval explicitly commits to pricing the drug between 230,000 and 250,000 RMB after its launch, fulfilling the promise made by Xuejun Yu and his team a decade ago—to create affordable cell therapies for ordinary citizens.

Summary

In addition, HuaDao CAR-Tcell has a very broad CAR-T layout. Apart from its first CAR-T cell targetingRefractory and relapsed non-Hodgkin lymphoma, with 3 clinical-stage pipeline products,HD003 cells,HD004 cells,HD006 Cells,Indications include hematological malignancies and solid tumors.

1. HuaDaoBiological Products《Dao Dynamics | Making Cell Drugs Affordable for the Chinese People! HuaDao CAR-Tcell Tackles the Entire Industry Chain, Breaking the High-Cost Barrier in the International Cell Drug Market》