Heyuan Bio's Yuoruida® Becomes First CAR-T Therapy to Pass Dual Preliminary Reviews for 2026 National Reimbursement Drug List and Commercial Health Insurance Innovation Drug List, Securing First-Ever Indication Expansion in Commercial Insurance Directory

On June 29, 2026, the National Healthcare Security Administration officially released the Preliminary List for Formal Review of Adjustments to the 2026 National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalogue and the Commercial Health Insurance Innovative Drug Catalogue, along with official policy interpretations. A total of 818 application submissions were received for this catalogue adjustment, covering 674 generic drug names. After rigorous preliminary review and screening,Juventas’ independently developed, original CAR-T cell therapy product, Yuanruida® (nacabtagene autoleucel injection), has successfully stood out by simultaneously passing the initial review for inclusion in the National Essential Medical Insurance Drug List and the initial review for the Innovative Drug List of Commercial Health Insurance. It has become one of the few CAR-T therapies this year to secure dual access through both “Basic Medical Insurance + Commercial Insurance” channels.

According to the latest preliminary list of drugs in the National Essential Drug List that have passed the formal review, as publicly announced by the National Healthcare Security Administration in 2026, Yuanruida® (Nakiolencel Injection) is included (Serial No. 185). Leveraging dual eligibility criteria for new drugs not currently listed—Criterion 1 (a Class 1 new drug with a new generic name approved after January 1, 2021) and Criterion 5 (already included in the 2025 Edition of the Commercial Health Insurance Innovative Drug Directory)—Yuanruida® (Nakiolencel Injection) successfully passed the initial review, thereby officially qualifying for subsequent expert evaluation, clinical value assessment, and national medical insurance price negotiations.

Nakiolencel Injection is currently the only CAR-T cell therapy product approved in China for both adult relapsed/refractory B-cell acute lymphoblastic leukemia and relapsed/refractory large B-cell lymphoma.

Yuanruida® (Nakiolencel Injection) is included in the adjustment of the commercial insurance innovative drug catalog this time.ComeHistoric Breakthrough: The newly added indications for the commercial insurance catalog submission have successfully passed the formal review, becoming the first innovative drug to expand its indications within the catalog and pass the initial review since the implementation of the National Commercial Health Insurance Innovative Drug Catalog system.

According to the regulations of the National Healthcare Security Administration, the Commercial Insurance Innovative Drug Catalog is divided into two channels: “New Access for Drugs Outside the Catalog” and “New Indications for Drugs Within the Catalog.” Yuanruida® (Nakiolencel Injection) was included in the first batch of the Commercial Insurance Innovative Drug Catalog in 2025, further improving the multi-tiered medical security framework of “basic medical insurance covering basic needs, and commercial insurance covering high-value specialized drugs.”

As a Class 1 novel biologic drug with global independent intellectual property rights, Yuanruida® (naciolencel injection), a CD19-targeted CAR-T therapy, leverages the unique HI19a antigen-recognition sequence to demonstrate superior long-term survival benefits in two indications: adult relapsed or refractory B-cell acute lymphoblastic leukemia and large B-cell lymphoma. Its simultaneous passage of the preliminary reviews for both the National Essential Drug List and the Commercial Insurance Innovative Drug Directory represents a strong endorsement by national healthcare security authorities of its clinical value and product innovation.

Since its market launch, Juventas has been committed to exploring a sustainable development path for high-value cell therapy drugs that maximizes clinical benefits and rationalizes payment burdens. Moving forward, Juventas will fully cooperate with subsequent expert reviews and price assessments, while continuing to deepen its focus on original innovation in cell therapy. As multi-tiered payment channels gradually break down access barriers to CAR-T therapy, domestically developed cell therapy drugs in China will be accelerated into a diversified security system, enabling more patients with leukemia and lymphoma to truly access and afford cutting-edge innovative treatments.

Dr. Lu Lulu, Founder and CEO of Juventas, stated:

Juventas’ Naqiorencel Injection (brand name: Yuanruida®) has successfully passed the preliminary reviews for both the 2026 National Essential Medical Insurance List and the Commercial Insurance Innovative Drug Directory. This achievement is not only a tremendous encouragement to our commitment to independent innovation but also a testament to the continuous improvement of China’s multi-tiered medical security system. Notably, the successful preliminary approval for the expansion of indications within the Commercial Insurance Directory sets an industry precedent, truly embodying the original intent of the directory’s mechanism of “dynamic adjustment, continuous optimization, and expansion of the beneficiary population.” Looking ahead, Juventas will fully cooperate with the subsequent review and negotiation processes of the National Healthcare Security Administration, while deepening collaboration with commercial insurance institutions to accelerate the implementation of diversified payment solutions. We will continue to focus on original innovation in the field of CAR-T cell therapy, constantly improving product accessibility, so that China’s originally developed CAR-T therapies can benefit a broader patient population and help more families reignite hope.