999,000-Yuan CAR-T Therapy Covered by Insurance: He Yuan Bio Leads as First CAR-T Included in China's Commercial Health Insurance Innovation Drug List

"Negotiations Successful!" On the afternoon of November 2, Lü Lulu, CEO of Juventas, confirmed the news to the media with a smile after completing the commercial insurance directory negotiations for the 2025 National Medical Insurance in China.

These simple three words, for the CAR-T therapy that has repeatedly failed to enter the national medical insurance directory over the past four years, mark a brand-new starting point. Unlike previous years when it directly aimed for basic medical insurance, this year...Five CAR-T Drugs Shift Collectively，Targeting the "Commercial Insurance Innovative Drug List" which was established for the first time.

The national medical insurance negotiation launched on October 30, 2025, represents its greatest institutional innovation with the formal introduction for the first time."Commercial Insurance Innovative Drug List" Mechanism, opening up an independent "second front" for the payment of high-value innovative drugs.

The core reason why Juventas was able to gain the upper hand in this crucial negotiation lies in its "game-changing advantage" —Yuan Ruida® (Najiolun Sai Injection)。

This CAR-T product, which was approved for marketing in 2023, isFirst in ChinaA CAR-T product for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), alsoThe first product with full independent intellectual property rights in ChinaCD19 CAR-T. The globally unique CD19 scFv (HI19a) sequence it employs provides it with a differentiated competitive advantage.

For patients with a median survival of only 2-6 months under traditional treatment, Nakiolumab achieved results in key clinical studies.82.1% response rate, bringing breakthrough survival hope. However, like all CAR-T therapies, its high personal production cost is an unavoidable challenge. Juventas' strategy is to price it at999,000 yuan/vial, becoming one of the currently marketed CAR-T drugs in ChinaLowest Priceproducts, which has created a decisive advantage for its entry into the commercial insurance catalog with relatively flexible payment thresholds.

CAR-T therapy is a personalized cellular immunotherapy, and its "custom-made" nature for patients determines that it is difficult to significantly reduce costs through scaled production.Million-dollar-level single treatment costMaking it always difficult to cross the threshold of the national medical insurance's "basic protection" positioning.

The following table clearly illustrates the current market landscape and payment exploration of major CAR-T products in China:

Qiu Shi Pharmacy Collection

In fact, before the official mechanism of commercial insurance catalog appeared, the market had spontaneously formed.Diverse Payment LandscapeThe prototype. According to statistics, by the end of 2024, the CAR-T products of Fosun Kite and WuXi Jumo have been included in more than 80 and 70 commercial medical insurance plans, respectively. At the same time,Exceed60% of the Huiminbao projectsCAR-T therapy has also been included in the coverage scope, laying a market foundation for the official launch of the commercial insurance catalog.

The collective inclusion of CAR-T drugs in the commercial insurance directory highlights the payer's recognition of high-value innovative drugs.Recognition of Clinical Value, instead of being stuck in a rigid "price competition."

According to the data from the "White Paper on Diversified Payment for Innovative Pharmaceuticals and Medical Devices in China (2025)", China's per capita expenditure on innovative drugs in 2023 was only$20, much lower than in mature markets like Europe and the U.S. The establishment of a commercial insurance catalog creates a payment space outside of basic medical insurance that acknowledges the value of innovative drugs which, while highly valuable, cannot yet be priced at rock-bottom levels.

Juventas Team Only Used20 minutesThis detail itself reflects the inclusiveness and efficiency of the new mechanism.

Zhao Heng, founder of Latitude Health, a medical strategy consulting firm, pointed out another practical value of the commercial insurance catalog:Convenient AccessHe pointed out that innovative drugs included in this directory can be directly listed online according to regulations and enjoy supportive measures such as simplified procedures, which can greatly accelerate the speed of products entering hospitals and promote market expansion.

As a corporate negotiator said: "We don't need to directly slash prices significantly; we just need to recover the substantial R&D costs incurred upfront. Forcing highly innovative products to drastically cut prices would be a blow to our innovation." The commercial insurance catalog strikes a valuable balance between value recognition and cost recovery.

Juventas’ “successful negotiation” has thus transcended the company's own commercial success, becoming aLandmark EventIt indicates that, for high-value innovative drugs such as CAR-T, which can cost millions of yuan, there is no longer a need to linger hopelessly outside the gate of medical insurance.

A fast track named "Commercial Insurance Innovative Drug List" has been launched. In the future, aBasic medical insurance covers the basics, while commercial insurance supplements the high-end.The multi-level medical security system is accelerating from blueprint to reality. Although the specific implementation effects of the commercial insurance directory and the actual benefits to patients remain to be seen, the wheels of payment mechanism reform are already rolling forward, injecting new certainty into the innovation of China's biopharmaceuticals industry.

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