Global First Solid Tumor CAR-T Approved: A $10B Market Opens as 'Premium-Priced' Therapies Face Disruption

Ji Yuanyuan, reporter for 21st Century Business Herald

On June 22, the National Medical Products Administration announced that it had approved, through the priority review and approval pathway, the marketing application for Suricabtagene Autoleucel Injection (brand name: Kailimei) submitted by Kaixing Life Science (Shanghai) Co., Ltd., a subsidiary of CARsgen Therapeutics Holdings Limited. This is the first CAR-T cell therapy product globally approved for the treatment of solid tumors, indicated for advanced gastric/gastroesophageal junction adenocarcinoma that is CLDN18.2-positive, HER2-negative, and has failed at least two prior lines of therapy.

More than a decade after the advent of CAR-T therapy, the over ten approved products worldwide remain confined to the field of hematologic malignancies, while solid tumors, which account for approximately 90% of all malignant cancers, have long been a “forbidden zone” inaccessible to CAR-T therapies. The breakthrough achieved by CARsgen Therapeutics marks a leapfrog advancement for China in the frontier field of cell and gene therapy (CGT), transitioning from “following and keeping pace” to “taking the lead.”

Two months ago, another piece of news similarly stirred the market’s nerves. On April 30, 2026, the marketing application for Wanji Aolunsai Injection, a Class 1 new drug independently developed by HuaDao CAR-Tcell, was officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), with proposed indications for the treatment of refractory and relapsed non-Hodgkin’s lymphoma. What truly caused an uproar in the market was its previously announced pricing: just over RMB 200,000. This price represents a near “cliff-like” drop compared to the current pricing of domestically marketed CAR-T products, which range from RMB 999,000 to RMB 1.29 million per dose.

The “ascendancy” of the world’s first CAR-T therapy for solid tumors and the “breakthrough” of “astronomically priced” CAR-T therapies are jointly outlining the dual narrative of China’s CAR-T industry in 2026.

Solid Tumor “Fortress” Breached

Tumors are primarily classified into two major categories: hematologic malignancies and solid tumors. Solid tumors refer to malignant neoplasms that grow within organ tissues and exhibit a fixed morphology, such as gastric cancer, lung cancer, and liver cancer, accounting for approximately 90% of all malignant tumors. Due to their complex microenvironmental barriers—characterized by the coexistence of physical barriers and immunosuppressive mechanisms—the treatment of solid tumors is significantly more challenging than that of hematologic malignancies.

Previously, all CAR-T products launched globally were concentrated in the field of hematologic malignancies. An executive from a pharmaceutical company once vividly likened solid tumors to “mafia gangs hiding in fortresses,” in contrast to the “scattered and disorganized” cancer cells seen in hematologic cancers, noting that this distinction forces CAR-T therapies into arduous “urban warfare.”

Caris Life Sciences’ breakthrough stems first from the precise identification of its target. Public information indicates that the company was the first globally to identify and validate Claudin18.2 as a target for CAR-T therapy. This specific protein is abnormally overexpressed in more than two-thirds of gastric cancers and a significant proportion of pancreatic cancers, while it is not expressed in gastric stem cells or other vital organs, allowing for controlled targeting.

Clinical data have demonstrated the clinical value of this breakthrough. A large-scale, multicenter, confirmatory randomized controlled trial involving more than 20 leading medical institutions across China showed that this CAR-T therapy increased the median overall survival from less than 4 months to nearly 9 months in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had failed second-line treatment. The relevant data were published in The Lancet, a premier international medical journal. In earlier exploratory studies, surucabtagene autoleucel used as sequential therapy following first-line treatment for gastric cancer achieved an objective response rate of 100% in four patients with target lesions; two of these patients underwent surgical resection after infusion and achieved long-term survival of nearly five years.

From the perspective of the global R&D landscape, China has taken a leading position in the CAR-T development pipeline. An analyst from the pharmaceutical sector at a securities firm told reporters from 21st Century Business Herald that among the top 10 institutions globally with CAR-T pipelines under development, more than half are Chinese institutions. However, there is a significant gap between “under development” and “approved.” The challenges associated with developing CAR-T therapies for solid tumors have led many pharmaceutical companies to scale back their efforts or even withdraw entirely. The recent approval granted to CARsgen Therapeutics not only fills a gap in later-line treatment options for advanced gastric cancer but also ushers in a new era of cellular therapy for solid tumors.

Currently, the global CAR-T market is experiencing rapid growth. According to industry data, the total sales of seven CAR-T therapies worldwide rose from $4.5 billion in 2024 to $5.967 billion in 2025, representing a year-over-year increase of 31.66%. Among these, ciltacabtagene autoleucel, developed by Johnson & Johnson and Legend Biotech, achieved annual net sales approaching $1.9 billion, nearly doubling its previous year’s figure and entering the “billion-dollar molecule” club. Industry forecasts predict that the global CAR-T cell therapy market will reach RMB 263.86 billion by 2032, with a compound annual growth rate (CAGR) of 29.4%.

The Chinese market is also expanding rapidly. According to data from industry agencies, the size of China's CAR-T market in 2025 was approximately RMB 3.82 billion. However, this figure still differs by an order of magnitude from the global market size of nearly USD 6 billion.

In terms of market landscape, Fosun Kite’s axicabtagene autoleucel injection (brand name “Yikaida”) continues to hold the leading position in the Chinese market, while companies such as Heyuan Biologics, Chongqing Precision Biotechnology, and JW Therapeutics demonstrate a competitive landscape characterized by diverse followers.

Furthermore, as of now, eight CAR-T products have been approved in China, all of which are autologous CAR-T therapies. These products require the establishment of a dedicated production line for each patient, involving over 600 manufacturing steps and executed by more than 20 specialized engineers. Each patient-specific batch must also meet approximately 20 release testing criteria. The complex, personalized manufacturing process constitutes the core reason behind the "exorbitant pricing" of CAR-T therapies.

However, high prices have not hindered the pace of commercialization.

“Sky-High-Priced Drugs” Await a Breakthrough

Less than two months after the approval of the world’s first CAR-T therapy for solid tumors, HuaDao Bio’s marketing application for Wanjiolencel Injection was accepted.

Public records indicate that HuaDao Bio was established in 2017. Its founder, Yu Xuejun, is a retired military physician who formerly served in the Department of Hematology at Changhai Hospital. The company has pursued a dual-innovation strategy across the entire industry chain, combining “cellular drug R&D” with “breakthroughs in key industrialization equipment and technologies.” Over seven years of development, HuaDao has overcome critical industrialization bottlenecks and core technological challenges, including key production equipment for CAR-T manufacturing, supporting single-use consumables, and intelligent liquid nitrogen cold-chain transportation.

In June 2023, HuaDao CAR-Tcell’s key industrial technologies and equipment for CAR-T cells officially passed the linked review by the Center for Drug Evaluation (CDE), making it the only enterprise in China with independent intellectual property rights across the entire CAR-T cell industry chain.

From a cost perspective, the core logic for cost reduction lies in two key aspects: on one hand, replacing expensive import-dependent equipment and consumables with domestically produced alternatives. According to Yu Xuejun’s previous public statements, the price of a set of imported CAR-T production consumables once exceeded RMB 100,000, whereas after complete independent development, the cost of consumables dropped to just over RMB 2,000, merely 1/50th of the import price.

On the other hand, large-scale industrialized production dilutes unit costs. HuaDao’s independently developed fully automated, closed, and unmanned production system will increase capacity by more than 50 times compared to domestic and international peers. The CAR-T cell therapy fully automated production base currently under construction in Xiaokunshan Town, Songjiang District, will have an annual capacity of 9,000 patient doses in its first phase, far exceeding the current maximum annual capacity of less than 300 patient doses for domestically marketed CAR-T products.

However, this “ultra-low-price” logic has also drawn skepticism within the industry. Some industry insiders pointed out that the actual manufacturing cost of traditional autologous CAR-T therapy is at least RMB 250,000 to 350,000; if the end-user price is only slightly above RMB 200,000, it implies even lower costs, making it “unclear how the relevant companies have achieved this.”

According to foreign studies, the cost of materials for producing each dose of CAR-T is approximately $43,000 (equivalent to about 310,000 RMB). This does not include expenses related to research and development, quality control, or cold-chain transportation.

Addressing the significant price disparity, the aforementioned analyst pointed out that high-end innovative products will generally maintain premium pricing. Taking CARsgen Therapeutics’ surucabtagene autoleucel as an example, as the world’s first CAR-T therapy for solid tumors, it involves substantial R&D investment and faces high technical barriers, making significant price reductions unlikely in the short term. The official list price of zevorabtagene autoleucel injection, previously approved by CARsgen Therapeutics, is RMB 1.15 million per dose. The breakthrough clinical value of CAR-T therapies for solid tumors dictates that they will continue to command premium pricing for a certain period.

However, improvements on the payment side are underway. In December 2025, the National Healthcare Security Administration released the first edition of the "Catalog of Innovative Drugs for Commercial Health Insurance," marking the first inclusion of five marketed CAR-T products within the reimbursement scope of commercial insurance. Regions such as Jiangsu and Tianjin have incorporated domestically produced CAR-T therapies into medical insurance negotiations, achieving price reductions of over 40%.

Currently, independent innovation is driving prices downward. If HuaDao CAR-Tcell ultimately gains approval for market launch at a price of just over RMB 200,000, it will become a “disruptive innovator” in the CAR-T pricing landscape. Achieving this price range relies on two pillars: full industrial chain self-sufficiency and controllability, and large-scale industrialized production. Notably, however, HuaDao’s Wanji Aolunsai Injection has not yet been approved, and the final pricing remains subject to the officially listed online procurement price.

According to public information, HuaDao Bio has signed a listing coaching agreement and plans to strive for listing on the STAR Market.

How Far Are We from Universal Accessibility?

On the multi-billion-dollar track of cell and gene therapy, HuaDao Bio’s entry will ignite a genuine “cost war” that shakes up traditional pricing models. This is not only a challenge to the exorbitant pricing structure of CAR-T therapies, but also directly determines whether this breakthrough technology can transition from the laboratory into widespread clinical use for the general public.

Currently, the iterative advancement of CAR-T technology is driving a fundamental transformation. From a longer-term perspective, in vivo CAR-T technology is emerging. This next-generation cell therapy involves a single intravenous injection to directly deliver CAR genes into the patient’s body, enabling T-cell engineering in situ. By bypassing the complex ex vivo manufacturing steps associated with traditional CAR-T therapies, this approach holds the promise of significantly reducing costs and shortening treatment cycles. Currently, there are over 1,500 related pipelines globally.

Orient SecuritiesThe research report points out that autologous CAR-T therapy is highly attractive due to its superior efficacy, but the high cost leads to a significant price disadvantage. In vivo CAR-T therapy represents a potential solution to this issue.

In 2026, the Chinese innovative drug business development (BD) market has seen in vivo CAR-T emerge as the hottest sector. Eli Lilly secured two deals within four months, while AstraZeneca, AbbVie, BMS, and Gilead are fiercely competing, strategically positioning themselves in areas such as in vivo cell engineering, RNA delivery, and targeted viral vectors.

In a previous interview with a reporter from 21st Century Business Herald, Dr. Liu Yarong, Founder and CEO of Gravel Biotech, stated that in vivo CAR-T therapy can directly achieve CAR expression within patients’ T cells, eliminating the need for traditional autologous CAR-T procedures such as cell separation, expansion, and lymphodepleting preconditioning. This approach fundamentally addresses the three core challenges of conventional CAR-T therapy: high cost, prolonged treatment timeline, and significant toxicity.

In addition, Liu Yarong believes that betting on TILs has become a viable option. “CAR-T targets a single antigen, but solid tumors are highly heterogeneous, with each tumor cell expressing different antigens. Moreover, T cells naturally have poor ability to infiltrate solid tissues. TILs are expanded from tumor tissue and naturally express polyclonal TCRs, enabling them to recognize multiple neoantigens and address the issue of tumor heterogeneity.”

This assessment is being validated by clinical data. GT101 injection, the first TIL cell therapy approved for clinical trials in China, achieved an objective response rate of 45.5% and a disease control rate of 90.9% in its Phase I trial for cervical cancer, with one patient maintaining a complete response for over 14 months. The world’s first TIL therapy was approved for market launch in February 2024, confirming the druggability of this technological approach.

The aforementioned analyst outlined three tiers for reporters from an investment perspective: “CAR-T and TIL products with high certainty have already been approved, belonging to mature products; allogeneic CAR-T is a high-growth product; while in vivo CAR-T technology leads and has great potential, but faces uncertainties in regulation, CMC, and clinical aspects, representing a long-term investment opportunity with high odds.”

From a cost perspective, TIL therapy is in the same order of magnitude as domestically produced CAR-T therapies. The production cost of such gene-engineered products amounts to only a fraction—tens of times lower—than that of CAR-T, reaching just a few thousand yuan, which is comparable to the production costs and economies of scale associated with antibodies.

The approval of the world’s first CAR-T therapy for solid tumors in China marks a historic leap for the country in the field of cell and gene therapy (CGT), transitioning from a follower to a leader. Furthermore, if the price of CAR-T therapies becomes more affordable for the general public, it will signal an acceleration in the transformation of the CAR-T industry.

As an industry observer remarked, “The future of CAR-T therapy lies not in how many more people it can keep alive longer, but in how many can afford it.” The approval of the world’s first CAR-T therapy for solid tumors marks a “summit” at the technological level, while the substantial reduction in CAR-T pricing represents “inclusive access” at the industrial level. Only when these two forces converge can China’s CAR-T industry truly complete its full transition from “0 to 1” to “1 to N.”