Heyuan Biotech's YORWIDA® (Inaticabtagene Autoleucel) Included in China's National Healthcare Security Administration Commercial Health Insurance Innovative Drug List

This inclusion not only marks a significant breakthrough in the payment accessibility of China-developed CAR-T products, bringing new hope of "affordable, accessible, and curable" treatment to patients with relapsed or refractory acute lymphoblastic leukemia, but also represents a key advancement in the construction of a multi-layered medical security system in China, marking an important step forward in meeting the accessibility of high-value innovative drugs urgently needed in clinical practice.

As the only CAR-T product approved in China for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), Najiolumab Injection features a unique CD19 scFv (HI19a) sequence structure and internationally leading manufacturing processes and quality systems, stemming from the long-term technological innovation accumulation at the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences. Najiolumab Injection is highly innovative and demonstrates significant clinical value.Real-world effectiveness rate as high as 92.8% post-market, 100% MRD negativity rate, 1-year overall survival rate of 90%, long-term survival benefits from a single infusion.Patients can return to normal life, making adult acute lymphoblastic leukemia a "curable" disease.

With its excellent efficacy and safety, Juventas' Nakiolumab InjectionReceived the "Breakthrough Therapy" designation and "Priority Review" status from the National Medical Products Administration (NMPA) of China and the Saudi Food and Drug Authority (SFDA), as well as the "Orphan Drug" designation from the U.S. FDA.. Naciorl Injection orThe Only CAR-T Product Selected for the National Ministry of Industry and Information Technology's First Batch of "Biomanufacturing Landmark Products" ListIn addition, the new drug market approval for Naciorl Injection in the treatment of large B-cell lymphoma was officially granted by the National Medical Products Administration (NMPA) in November 2025, becomingThe Only CAR-T Product in China Covering Two Major Hematological Tumor Indications: Leukemia and Lymphoma`, bringing breakthrough treatment options to patients.`

The release of the "Commercial Health Insurance Innovative Drug List (2025)" is an important measure by the National Healthcare Security Administration to implement the decisions and arrangements of the Communist Party of China Central Committee and the State Council. It aims to improve the multi-level medical security system, further enhance the drug coverage for insured individuals, and support the high-quality development of innovative drugs. By including highly innovative drugs with significant clinical value and patient benefits into this list, it will effectively broaden payment channels, substantially reduce patients' financial burden, better meet the multi-level and diversified medication needs of the people, and also provide effective incentives for innovative drug companies, further strengthening their commitment to independent innovation.

CEO of Juventas:

The successful inclusion of Naciorl Injection in the National Healthcare Security Administration's "Commercial Health Insurance Innovative Drug Directory (2025)" is a recognition of Juventas' years of commitment to independent innovation and a strong affirmation of the clinical value of the company’s products. Moving forward, the company will closely collaborate with the National Healthcare Security Administration and commercial health insurance agencies to advance the implementation of relevant programs. At the same time, Juventas is dedicated to raising insurance awareness among patients and the general public, encouraging the purchase of corresponding commercial health insurance to build a safety net for personal health.

Juventas will also enhance the accessibility and patient coverage of its Najiolumab Injection through the inclusion in the "Commercial Health Insurance Innovative Drug List (2025)." The company aims to accumulate more clinical data, pharmacoeconomic data, and real-world application data while continuously reducing drug costs. This effort serves as preparation for the eventual inclusion in China's National Reimbursement Drug List (NRDL), demonstrating the company’s commitment to serving national strategies, supporting healthcare security, and promoting public health as part of its social responsibility.