Heyuan Bio's Self-developed Naji Orun赛 Injection Achieves Dual Milestones, Strengthening Competitive Edge in Cell Therapy

Recently, Juventas, a company within the SimbayPark industrial park, has been achieving frequent breakthroughs in the biopharmaceutical field. With its self-developed Naloracel Injection (Yuanruida®), the company has consecutively achieved two significant milestones. These accomplishments not only demonstrate the company's strong innovative capabilities but also inject robust momentum into the development of the park’s biopharmaceutical industry.

Recently, the Ministry of Industry and Information Technology of the People's Republic of China announced the "List of Landmark Products in Biomanufacturing (First Batch)." Juventas' self-developed CAR-T cell therapy product, Naciaurolsen Injection (brand name: Yuan Ruida®), has been successfully selected. The purpose of this list is to implement the spirit of the National New Industrialization Promotion Conference, promote breakthroughs in original and disruptive technologies, and accelerate the promotion and application of landmark products, transforming innovative achievements into real productive forces. After a rigorous process involving recommendations from provincial industrial and information technology authorities and expert evaluations, only 36 innovative products were selected. Notably, Juventas' Naciaurolsen Injection stands as the sole CAR-T cell therapy product in the biopharmaceutical field, underscoring its profound significance.

This achievement represents the country's high recognition of the technological innovation and industrial value of the Natrium Olerson Injection, and more importantly, a strong affirmation of Juventas' years of dedication to the cell therapy field and its commitment to independent innovation. Since its establishment in 2018, Juventas has focused on core technological breakthroughs and industrialization in the field of cellular immunotherapy, growing into a leader of independent innovation in China’s cell drug industry. The company is committed to becoming a globally leading next-generation biopharmaceutical enterprise driven by innovative cell and gene technologies. Juventas possesses full-process autonomous capabilities in R&D innovation, process development, manufacturing, and commercialization. It has applied for over 90 patents globally, earned the title of "National Intellectual Property Advantage Enterprise," been approved for a national postdoctoral research workstation, and selected for the National Key R&D Program by the Ministry of Science and Technology. It is also a certified specialized and new enterprise, a rising star in China's Greater Health Industry according to Forbes China, and recognized as an emerging force in China's healthcare sector by the Hurun Report. The company's independently developed core CAR-T product, Yuanruida®, was approved for marketing by the National Medical Products Administration in November 2023. It was named one of the "Top 10 Advances in China's Medicine and Biotechnology in 2023" by the Chinese Academy of Medical Sciences and selected as one of the "Top 10 Progresses in China's Medicine and Biotechnology in 2023" by the China Association of Biotechnology, offering patients a breakthrough treatment option.

In August 2025, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) officially designated Juventas' self-developed CAR-T product, Yuan Ruida® (Nagiolun Cell Injection), as a Breakthrough Therapy drug for the treatment of pediatric relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This marks a significant advancement for China-developed CAR-T products in the field of pediatric leukemia treatment, bringing new hope to more young patients and their families. Previously, the indication for Nagiolun Cell Injection in treating adult relapsed or refractory acute lymphoblastic leukemia was granted Breakthrough Therapy designation in December 2020.

Acute lymphoblastic leukemia (ALL) is the most common hematologic malignancy in children. Although combination chemotherapy and precise stratified treatment have significantly improved overall survival rates, 20%-25% of pediatric ALL cases remain refractory or relapsed. The effective rate of salvage treatment for primary refractory patients is only 31%, with a median overall survival (OS) of less than one year. As the number of treatment lines increases, the prognosis for pediatric ALL worsens and the cure rate declines. Post-relapse B-ALL patients exhibit strong chemoresistance, with a chemotherapy effective rate of approximately 25% and a median survival of 3.7 months, while also facing increased risks of treatment-related toxicity. Ultimately, affected children succumb to disease relapse or treatment-related adverse effects. Currently, relapsed or refractory B-ALL continues to severely threaten the lives of pediatric B-ALL patients in China. To date, there is no unified standard treatment regimen, and there is an urgent clinical need for more effective and safer therapeutic approaches to improve patient outcomes.

Najiceloleucel Injection, with its unique CD19 scFv, CAR structure, advanced manufacturing process, and quality system, has demonstrated outstanding clinical efficacy and safety in early clinical studies and registrational clinical trials. It has been granted Breakthrough Therapy Designation by the CDE, which will further accelerate its market approval process in the field of pediatric acute lymphoblastic leukemia. As China's first fully self-owned intellectual property CD19 CAR-T product, Najiceloleucel Injection has expanded its indications to include adult and pediatric relapsed or refractory B-cell acute lymphoblastic leukemia, lymphoma, and various types of autoimmune diseases. Its adult indication was approved for marketing in November 2023, making it the first CAR-T product in China approved for treating leukemia. The inclusion of pediatric relapsed or refractory B-cell acute lymphoblastic leukemia as a breakthrough therapy will further promote the recognition of this treatment in the field of pediatric leukemia, providing more precise and efficient treatment options for children with leukemia.

SimbayPark Industrial Park has been committed to creating a favorable innovation and entrepreneurship ecosystem, providing comprehensive support and services for入驻 enterprises. The innovative progress achieved by Juventas this time is not only a reflection of the company's own R&D strength but also a vivid portrayal of the vigorous development of the park's biopharmaceutical industry. In the future, the park will continue to leverage the advantages of industrial clustering to help more companies achieve innovative breakthroughs and jointly promote the high-quality development of the biopharmaceutical industry.