Race to Cut Prices of Million-Dollar Cancer Therapies
Although CAR-T therapy is hailed as a "miracle drug" for cancer treatment, its price has remained stubbornly high, consistently staying in the million-yuan range. To date, the only symbolic price cut has only managed to bring it down to 999,000 yuan, deterring many patients.
However, a recent piece of news seems to signal a turning point. According to Huadao Biotech, an innovative pharmaceutical company based in Songjiang, Shanghai, its first CAR-T drug targeting refractory and relapsed non-Hodgkin lymphoma has submitted a pre-marketing communication application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), which is expected to pave the way for the subsequent formal application.
What's even more eye-catching is that the company has also indicated that the price of this drug after its launch will be controlled at around 230,000 - 250,000 yuan, instantly bringing CAR-T from "sky-high prices" to an "affordable price." However, in the face of such a huge price gap, the market has not shown widespread optimism. Instead, it has fallen into silence and is waiting and watching.
In fact, low-cost CAR-T has been introduced in overseas countries such as India and Brazil. For example, NexCAR19, the first approved CAR-T therapy in India, was developed by the Indian biotech company ImmunoACT, and the cost of a single treatment is only 30,000 - 40,000 US dollars (approximately 200,000 - 300,000 yuan).
The core reason why the Indian version of CAR-T can significantly reduce the price lies in the implementation of multiple cost-saving strategies, including the local production of key raw materials, the optimization of production processes, and the relatively low labor cost advantage in the local area.
Judging from the public information, the price cut path planned by Huadao Biotech is similar to that of India, also focusing on cost control and the introduction of automated production technology. However, whether it can successfully replicate this model will actually face multiple challenges, such as the stricter regulatory review requirements in China and the market's trust in the quality and efficacy of low-cost innovative therapies. This is also the core reason why the industry is currently waiting and watching, looking forward to further developments.
Self-production of key raw materials fires the first shot in price cuts
Since the US FDA first approved CAR-T for the treatment of leukemia in 2017, this technology has witnessed rapid development globally, becoming an important breakthrough in the field of oncology treatment. China is one of the most active countries in CAR-T research. As of now, a total of 7 products have been approved for marketing, covering a variety of hematological tumor indications.
Despite the remarkable efficacy of CAR-T, its high price has made it a "medical luxury" that is out of reach for most people. The price of CAR-T overseas is usually as high as 400,000 - 500,000 US dollars, while in China, it mostly ranges from 1 million to 1.2 million yuan.
Professor Ma Jun, the director of the Harbin Institute of Hematology and Oncology, told a reporter from STAR MARKET DAILY that due to the high treatment cost, only about 4,000 patients have received commercial CAR-T treatment in the past 5 years since the first product was approved in China in 2021. This figure forms a sharp contrast with the huge treatment demand of about 60,000 - 80,000 applicable patients in China each year.
He further emphasized that although there are continuous innovations in clinical therapies, such as monoclonal antibodies, bispecific antibodies, and ADC drugs, CAR-T still has an irreplaceable position in the field of hematological tumor treatment. Whether used for advanced patients or as a second-line treatment option in the early stage, CAR-T has demonstrated excellent efficacy in the treatment of lymphoma and leukemia, which is its outstanding advantage.
The root cause of the high price of CAR-T lies in its highly personalized, labor-intensive, and multi-batch production method. For example, it is a "living drug" customized for each patient, so the cost cannot be reduced through mass production. At the same time, its production process involves many delicate and repetitive steps, highly relying on professional personnel to operate in a clean workshop, resulting in relatively high labor costs.
Therefore, reducing the production cost of CAR-T to make it more accessible to more patients has become a consensus in the entire industry, and promoting the local production of key raw materials is one of the most common measures.
This time, the reason why Huadao Biotech dares to announce a price in the "200,000-yuan range" is that the company has been building an independent industrial chain for many years. From core equipment and consumables to the most basic raw materials and reagents, all are independently developed and produced by the team.
Take the lentiviral vector as an example. It is not only one of the most important production raw materials for CAR-T but also the most expensive one. From overseas cases, many low-cost CAR-T products have reduced the product price by lowering the cost of lentiviral vectors.
In China, as early as the launch of its CAR-T product, Relma-cel Injection (trade name: Benoda®) in 2021, executives of Wuxiapptec Legend Biotech revealed in a media interview that they had started planning to transfer the technology of key raw materials such as viral vectors and plasmids and replace them with domestic products in order to reduce costs.
However, this process requires completing strict comparability studies and even clinical verification, which takes several years. It was not until October 2025 that Wuxiapptec Legend Biotech announced that the post-marketing supplementary application for Benoda® had been officially accepted by the National Medical Products Administration (NMPA) of China. The core content of this application is to switch the key raw material "lentiviral vector" in production to a fully self-produced domestic product (code name: JWLV011).
The announcement shows that the submission of this supplementary application is based on the data of a crucial phase II single-arm clinical study. The main objective of this study is to directly compare whether there is a clinically significant equivalence in the safety and efficacy of Relma-cel Injection produced by the new and old lentiviral vectors.
In response to an interview request from STAR MARKET DAILY, Wuxiapptec Legend Biotech provided further clarification. The company pointed out that due to the high degree of "personalization" and "heterogeneity" of autologous CAR-T cell immunotherapy products, they have "complexity" and "particularity" in production processes and quality control, and the R & D and production investment are higher than those of traditional biopharmaceuticals.
The lentiviral vector, as a key tool for delivering the CAR gene, plays an important role in cell therapy products. However, the lentiviral vectors currently used in production rely on foreign suppliers, which are expensive and have unstable supply, greatly restricting the commercial production and clinical development of Relma-cel.
To this end, Wuxiapptec Legend Biotech has been continuously exploring domestic solutions. It has not only built a high-standard lentiviral vector production workshop but also successfully developed a lentiviral vector with independent intellectual property rights. Currently, the post-marketing supplementary application for Benoda® to use domestic viral vectors has been accepted by the drug administration. If the progress goes smoothly, the company expects to achieve the localization of viral vectors in 2026, thereby significantly reducing the product cost and benefiting more patients.
"Automation" drives the CAR-T manufacturing revolution
On the other hand, the preparation of traditional CAR-T highly depends on manual labor, and the limited production capacity is a prominent issue. Therefore, optimizing the production process towards automation and intelligence to improve production capacity and efficiency is also regarded as an important way to reduce the production cost of CAR-T.
Take NexCAR19 of ImmunoAct as an example. Although the company has not disclosed all the details, it revealed in an interview that it was able to significantly reduce costs because it found a cheaper way to mass-produce engineered cells. According to industry speculation, this "cheaper way" may involve the use of non-imported automated production systems and equipment.
Such intelligent equipment is usually called an "all-in-one machine," which can integrate multiple steps such as cell separation, activation, transduction, and expansion in the same closed system and complete them automatically. It not only significantly reduces the dependence on operators and human errors but also further saves facility investment because it can operate in a low-GMP-grade (Class C) environment without the need for an expensive Class A clean room.
Therefore, shifting from a manual and open operation mode to a closed and automated production process has gradually become a consensus among CAR-T pharmaceutical companies. This emerging demand has also driven the prosperity and development of the upstream cell preparation tool field.
According to public information, Huadao Biotech started the independent research and development of a fully automated, fully enclosed, and unmanned production system early on. The fully automated, fully enclosed, and unmanned production base for personalized CAR-T cell drugs built by the company in Xiaokunshan Town, Songjiang, has an annual production capacity of 9,000 person/doses in the first phase, far exceeding the current annual production capacity of less than 300 person/doses of the highest-selling domestic products.
Fosun Kary, a cell therapy subsidiary of Fosun Pharma, has also been continuously exploring in this direction and has cooperated with Saiqiao Biotech.
In November 2025, Fosun Kary released a "rapid automated production and release platform" developed based on Saiqiao's equipment at the American Society of Nephrology Kidney Week (ASN Kidney Week). It is reported that this platform is equipped with Saiqiao Biotech's self-developed CellFAB One series of fully automated cell preparation systems, which can achieve the rapid production and detection release of CAR-T cells within 48 - 96 hours. It is worth mentioning that CellFAB One can complete production in a Class C environment, and it is said that it can directly reduce the production cost by 90%.
According to Saiqiao Biotech, in cooperation with other CAR-T companies, by upgrading the CAR-T production process from "semi-automated" to a "fully automated and fully enclosed" system, the investment in labor and factories can be reduced to 10% - 20% of the original, laying the foundation for related products to enter the price range of 100,000 - 150,000 yuan in the future.
STAR MARKET DAILY sent an interview request to Fosun Kary regarding the cooperation details between the two companies and the specific application progress of automated equipment in CAR-T production, but as of press time, no response has been received.
Currently, Wuxiapptec Legend Biotech widely uses imported automated equipment in its production and preparation process, but the company said that it has listed the domestic substitution of production equipment and consumables as an important task and expects to submit relevant change applications to the National Medical Products Administration in 2026. In the future, Wuxiapptec Legend Biotech will focus on building a rapid process platform and an integrated production and manufacturing platform, integrating the internationally advanced decentralized production model, thereby continuously reducing production costs and improving production efficiency.
It should be noted that as a "living cell drug," the production process of CAR-T therapy is itself the core part of the drug quality. Therefore, although the transformation of the production process towards automation and closure has a significant cost-saving effect, the industry still highly concerns its potential impact on the consistency of product efficacy and long-term safety.
An industry insider told a reporter from STAR MARKET DAILY that currently, except in a few countries such as India, most CAR-T products produced by automated equipment can only be used for scientific research purposes and have not been widely approved for commercial treatment. Therefore, as Huadao Biotech submits a pre-marketing communication application, the industry is closely watching the final review attitude of the drug regulatory department.
Regardless of the outcome, for enterprises, in the face of the competitive pressure of the accelerating iteration of new technology routes, it is urgent to promote the price cut of CAR-T. Currently, all the commercially available CAR-T products globally are autologous CAR-T. In recent years, emerging technology routes such as universal CAR-T (allogeneic CAR-T) and in vivo CAR-T have developed rapidly and have also shown significant cost advantages.
Universal CAR-T uses T cells from healthy donors for standardized and large-scale preparation, thereby significantly reducing the single-treatment cost for patients. In vivo CAR-T technology skips the complex and expensive in vitro preparation process and realizes "in vivo drug manufacturing," fundamentally simplifying the process and reducing costs.
This cost-reduction race for accessibility has quietly entered the countdown.
This article is from the WeChat official account "STAR MARKET DAILY", author: Xu Hong, published by 36Kr with permission.