CAR-T Therapies Vie for Historic First Inclusion in China's Basic Medical Insurance Catalog
核心洞察
Two CAR-T therapies, Heyuan Bio (搜索)'s Nakiolunsa Injection (搜索) and WuXi Juno (搜索)'s Relmacabtagene Autoleucel, are negotiating for inclusion in China's basic medical insurance catalog during the 2026 NRDL talks.
If any CAR-T therapy succeeds, it would mark the first time a cell therapy priced in the millions breaks through the basic medical insurance payment threshold, holding epoch-making significance.
The dual-catalog model (basic medical insurance plus commercial health insurance) is being explored to balance fund sustainability with patient access for high-cost innovative drugs.
Two CAR-T cell therapies are vying for what would be a landmark first: inclusion in China's basic medical insurance catalog. On the second day of the 2026 National Reimbursement Drug List (NRDL) negotiations, Heyuan Bio (搜索)'s CD19 (搜索)-targeted CAR-T therapy Nakiolunsa Injection (搜索) and WuXi Juno (搜索)'s Relmacabtagene Autoleucel (Ruijiolunsa Injection) both approached the negotiation table, according to on-site reporting by Shanghai STAR Market Daily.
The stakes are considerable. CAR-T therapies have historically been among the most watched categories in NRDL negotiations. Constrained by the industry's implicit threshold of "no negotiations above RMB 500,000, no inclusion above RMB 300,000," several CAR-T products failed to secure a spot in the basic medical insurance scheme in recent years despite passing preliminary reviews.
Industry analysts point out that if any CAR-T therapy is successfully included in the basic medical insurance catalog this time, it would hold epoch-making significance. This would not only mean that cell therapy drugs priced in the millions will break through the basic medical insurance payment threshold for the first time, significantly alleviating the medication burden for patients with hematologic malignancies such as lymphoma (搜索) and leukemia (搜索). It would also establish a new pricing paradigm for high-cost cell therapies within China's medical insurance system, reshape the commercialization path for innovative cell drugs, and provide key samples and important references for the access mechanisms of similar products and other high-priced innovative drugs in the future.
A Dual-Catalog Pathway for High-Cost Innovation
Both CAR-T products had previously entered the first edition of the Commercial Health Insurance Innovative Drug List. In 2025, Heyuan Bio (搜索)'s Nakiolunsa Injection (搜索) was included in that inaugural list, and in 2026 the product aimed for inclusion in the National Essential Medical Insurance List while also applying for adjustments to indications within the commercial insurance list. WuXi Juno (搜索)'s Relmacabtagene Autoleucel had likewise entered the first edition of the Commercial Health Insurance Innovative Drug List.
Since the introduction of the first commercial health insurance innovative drug catalog last year, this dual-catalog access model has been exploring a new pathway that balances fund sustainability with patient accessibility for high-cost innovative drugs. According to Li Tao, deputy director and spokesperson of the National Healthcare Security Administration, the agency will optimize and refine the commercial health insurance innovative drug catalog, recommending that innovative drugs exceeding basic medical insurance's scope—but demonstrating high innovation, significant clinical value, and clear patient benefit—be paid initially by commercial health insurance.
This "basic medical insurance + commercial health insurance" dual-guarantee approach aims to reduce the household economic burden on patients with serious illnesses. Under this framework, even for companies adopting a "dual filing" strategy targeting both catalogs, three outcomes remain possible: clearing the negotiation table for basic medical insurance inclusion, being transferred to the commercial insurance catalog for initial payment by commercial health insurance, or failing to make either list.
Additional CAR-T and Global First-in-Class Contenders
Beyond the basic medical insurance negotiations, Precision Biotech's Nakiocel Injection and Carsgen Therapeutics' Cilta-cel Injection—described as the world's first CAR-T product for treating solid tumors—have separately applied for inclusion in this year's commercial health insurance innovative drug catalog.
The negotiations also featured several "global first-in-class" products. Lunkangyilongtuomab (搜索), an EGFR (搜索)×HER3 (搜索) bispecific antibody-drug conjugate (ADC) brought by Bailidote under BaiLi TianHeng, was approved for market launch in June of this year for later-line treatment of recurrent/metastatic nasopharyngeal carcinoma (搜索). It is the world's first and currently the only approved bispecific ADC. Leveraging the newly added pre-declaration mechanism, it seamlessly qualified for the 2026 NRDL negotiations.
Huidian Bio's Aofumin, based on its "rice-based hematopoiesis" technology, was approved for market launch last July, becoming the first domestically approved recombinant human albumin drug. Relying on the market ramp-up of this product, Huidian Bio achieved revenue of RMB 18.2742 million in the first half of this year, a year-on-year increase of 43.77%; net profit attributable to shareholders was negative RMB 62.7565 million, representing a narrowing of losses compared to the RMB 81.6278 million loss in the same period last year. In May of this year, the price of Aofumin was reduced from RMB 890 to RMB 615, a decrease of over 30%, laying groundwork for its NRDL bid.
Rare Disease and Hemophilia Therapies
Among companies participating in the afternoon session, Roche, Sanofi, and Jiangsu Bejietai Biologics all had innovative drugs for hemophilia (搜索)—a rare disease—pass the initial review for inclusion in this year's NRDL. Bejietai Biologics (a wholly-owned subsidiary of Shutaishen) saw its drug Pomitase Alfa (搜索) for Injection (brand name: Bojianing) approved for market launch only in June of this year.
Compared with other hemophilia (搜索) therapies, the active ingredient in Bojianing is a coagulation factor X activator purified from the venom of the Russell's viper. It is a global first-in-class bypassing agent whose mechanism of action involves specifically activating coagulation factor X (FX), converting it to FXa, thereby promoting the coagulation process to achieve hemostasis. It is specifically designed to address high-titer inhibitors, the most serious complication in hemophilia replacement therapy. Data indicates that the listed online price for Bojianing in Jiangsu Province is RMB 20,460 per vial (box).
Negotiation Dynamics and the Pre-Declaration Mechanism
The 2026 national medical insurance negotiations officially kicked off on September 5, with sessions expected to last four to five days—roughly a month earlier than previous years. According to the National Healthcare Security Administration, the overall pass rate for preliminary formal review reached 92%, up 8 percentage points from last year. New drugs dominated the submissions, with 343 new generic-name drugs approved within the past five years filed under Category 1 for off-catalog inclusion.
This year's scheduling differed markedly from previous years, abandoning the convention of organizing negotiations by therapeutic categories such as "digestive" or "antiviral." Instead, drugs spanning multiple traditional Chinese medicine and Western medicine categories were negotiated on the same day.
A pharmaceutical industry insider told reporters: "As long as companies balance their pricing well, the success rate of negotiations should be quite high, especially since expectations are set after pre-communications. As long as they do not become overly rigid, the overall market access process tends to proceed relatively smoothly."
Since 2018, the National Healthcare Security Administration has continuously improved the dynamic adjustment mechanism for the medical insurance drug catalog, adding a cumulative total of 949 drugs, including 199 innovative drugs. Behind this figure lies an ongoing exploration of transitioning the medical insurance catalog from "ensuring basic coverage" to "multi-tiered protection."