China's Huadao Biologics Submits IPO Filing as Its CAR-T Therapy Aims to Slash Cancer Treatment Costs from $170K to Under $30K

From Millions to Less Than 300,000 Yuan? CAR-T Therapy, Once Known as the "Miracle Cancer Drug," May Enter an Era of Greater Accessibility.

Recently, the Center for Drug Evaluation under the National Medical Products Administration (NMPA) announced that the marketing application for VaniCAR-Olunsa Injection, a CAR-T cell therapy developed by HuaDao CAR-Tcell (Shanghai) Biomedical Co., Ltd. ("HuaDao CAR-Tcell"), has been officially accepted.

Several CAR-T therapies have already been approved and applied both in China and internationally. One major reason why this yet-to-be-approved product from HuaDao CAR-Tcell has gained attention is that, by the end of 2025, the company mentioned externally that the current international average price for similar drugs exceeds 400,000 USD, while the average price in China is about 1.2 million RMB. However, this cellular drug, which is produced in China and fully independently intellectual property owned, costs only over 200,000 RMB.

How was it possible to reduce costs from millions to two hundred thousand? According to the content published on HuaDao CAR-Tcell's official WeChat account: Everything required for the production of cell drugs, from core equipment and consumables to the most basic raw materials and reagents, is independently developed and produced by the team. The company is the only one in China with full independent intellectual property rights over the entire CAR-T cell industry chain.

HuaDao CAR-Tcell also mentioned its advantages in production: the fully automatic, fully enclosed, unmanned production system independently developed by the company will increase capacity by more than 50 times compared to domestic and international peers, theoretically achieving "produce as much as clinical needs require." The company is currently constructing an automated, fully enclosed, unmanned production base for personalized CAR-T cell drugs in Xiaokunshan Town, Songjiang District. Upon completion of the first phase, the annual production capacity will reach 9,000 doses per year, far exceeding the current maximum annual capacity of less than 300 doses per year for products already on the market in China.

Currently, the approved CAR-T therapies are mainly autologous treatments, which are customized products. These therapies require the use of genetic engineering technology to artificially modify the T lymphocytes of cancer patients. After being massively cultured in vitro to generate tumor-specific CAR-T cells, they are reinfused into the patient’s body to attack cancer cells, thereby achieving the goal of treating the disease. The price generally reaches the million-yuan level, with the lowest pricing at 999,000 yuan.

Does HuaDao CAR-Tcell's CAR-T also belong to autologous CAR-T therapy? What specific cost reductions in processes contributed to the price of over 200,000 yuan? On May 6th, a reporter from The Paper attempted to contact HuaDao CAR-Tcell through various channels to learn more about the situation. As of press time, no response had been received. Public information shows that HuaDao CAR-Tcell has submitted a coaching filing report for its initial public offering and listing to the Shanghai Securities Regulatory Bureau.

From millions to more than 200,000 yuan, this price reduction is seen as quite challenging by many industry insiders. An insider pointed out to reporters that due to the complex preparation process—on one hand, labor, and on the other hand, reagents and consumables—the actual cost of traditional in vitro CAR-T therapy is at least between 250,000 and 350,000 yuan. If the final market price is over 200,000 yuan, it means the cost might be even lower, and it’s unclear how related companies have managed to achieve this.

Another person in the CAR-T industry also told The Paper that before the product is officially approved for marketing, it's impossible to know the price of a drug, and the final pricing will still depend on the listed price. Currently, CAR-T therapy can reduce some costs through optimized production and scaling up, but it’s hard to achieve significant price changes. Each patient's treatment involves not only the cost of production per batch, but also about 20 different testing and release criteria, plus labor costs, depreciation of plant equipment, and utility consumption, all of which are basically fixed and difficult to reduce. Additionally, pharmaceutical testing and quality control requirements, as well as fluctuations in raw material costs, could also affect pricing. Of course, if indications continue to expand and the number of patients using the therapy increases, CAR-T therapy might achieve the goal of lowering costs by spreading them out.

Jin Chunlin, Director of the Shanghai Health Development Research Center, believes that since it has not yet been approved, the specific price cannot be determined. If it can really drop from over a million yuan to more than 200,000 yuan, it would represent a significant transformation driven by three factors in CAR-T therapy: core technology, production models, and the industrial ecosystem. It would also mean that what was once an astronomical product has entered a more affordable and accessible phase for the general public. The reason traditional CAR-T therapies are priced at the million-yuan level lies in the high costs of customized production and imported materials. If these two factors are well controlled, it might be possible to achieve a substantial reduction in cost.

Due to the high cost of CAR-T therapy, it has not been included in the National Basic Medical Insurance Catalog. Policy support has been provided to address its payment challenges. By the end of 2025, the first edition of the Commercial Insurance Innovative Drug List will be published, which includes five CAR-T products. At that time, a company told reporters from The Paper that after entering the commercial insurance catalog, the official price of the company's CAR-T therapy would remain unchanged, but there would be a discounted price for insurance companies. This discount range is approximately between 15% and 50%, with increments of 5%. The final discount will be determined based on product characteristics, calculations, and evaluations.

Currently, the commercial sales performance of CAR-T therapies worldwide varies. For instance, in 2025, Janssen/Legend Biotech's Cilta-cel achieved net sales of approximately $1.9 billion, representing an 86% year-over-year increase, with over 10,000 patients treated; Gilead’s Yescarta, the world’s first approved CAR-T product, generated nearly $1.5 billion in global revenue in 2025, but experienced a 5% decline year-over-year; and Bristol-Myers Squibb’s (BMS) Breyanzi surpassed $1.3 billion in sales in 2025, marking an 82% year-over-year growth.

Eight CAR-T products have been approved in China, and some listed pharmaceutical companies have disclosed the sales data of related products in their financial reports. For instance, WuXi Jono generated nearly 219 million yuan in revenue from the sales of Relmacabtagene Autoleucel (brand name: Bynoda) in 2025, representing a 38.4% increase compared to 2024. In addition, the cumulative revenue from Zevocabtagene Autoleucel (brand name: Saikaze), produced by CARsgen Therapeutics, reachedHuadong MedicineReceived 218 valid orders, with a group revenue of approximately 126 million yuan;Fosun PharmaAs of the end of the reporting period in the 2025 financial report, Axicabtagene Ciloleucel Injection (trade name: Yikaida) has been covered by more than 110 municipal and provincial惠民保 (benefit insurance programs) and over 90 commercial insurance policies. The registered treatment centers have expanded to cover more than 29 provinces and cities in China, with a total number exceeding 210.