Heyuan Bio's Yuandar® (Najiorlense Injection) Listed in China's First Batch of 'Flagship Biomanufacturing Products' by MIIT

Aug 19, 2025 09:02 CST Updated 09:02

Juventas

Innovative Cell Therapy Drug Developer

Recently, the Ministry of Industry and Information Technology announced the first batch of "Biomanufacturing Iconic Products," with a total of 36 innovative achievements selected. Among them, the CAR-T cell therapy drug independently developed by Juventas.ObjectYuanruida® (Natrium Allogeneic CAR-T Injection)Becoming the List ofThe Only CAR-T Product, gaining national recognition once again for the industrialization and clinical application of China's original drugs. This selection not only highlights the technological breakthroughs and manufacturing capabilities in the field of cell and gene therapy in China, but also provides an important demonstration for accelerating the global reach of domestically produced innovative drugs.

Danlu Capital will continue to focus on cutting-edge biomanufacturing tracks such as cell and gene therapy, supporting...Original Technology + Industrialization CapabilityDriven by Innovation: China Goes Global.

Original text as follows:

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)," and Juventas' self-developed CAR-T cell therapy product, Nacioran Injection (brand name: Yuanruida®), has been successfully selected. This achievement not only represents the nation's high recognition of the technological innovation and industrial value of Nacioran Injection but also strongly affirms Juventas' years of dedication to the cell therapy field and its commitment to independent innovation.

List of Landmark Products in Biomanufacturing is issued by the Ministry of Industry and Information Technology of ChinaIn order to implement the spirit of the National Conference on the Promotion of New Industrialization, promote the tackling of original and disruptive technologies and the application of landmark products, accelerate the transformation of innovative achievements into real productive forces, and enhance the integrated development capability of biomanufacturing "technology research and development - production manufacturing - market promotion," based on relevant work arrangements and work plans, after procedures such as recommendations from provincial industrial and information technology authorities and expert reviews, a selection was formed. This time, a total of 36 innovative products were selected for the first batch.List of Landmark Products in Biomanufacturing: Juventas' self-developed innovative drug product, Naciorl Injection, falls within the biopharmaceutical field and is also the only CAR-T cell therapy innovative drug product selected.

Since its establishment in 2018, Juventas has focused on core technology breakthroughs and industrialization in the field of cellular immunotherapy. It has grown into a leader in China's cell drug industry, known for its independent innovation, and is committed to becoming a globally leading biopharmaceutical enterprise driven by next-generation cell and gene technologies. Juventas possesses end-to-end autonomous capabilities spanning R&D innovation, process development, manufacturing, and commercialization. The company has filed over 90 patent applications globally, earning recognition as a "National Intellectual Property Advantage Enterprise." It has been approved to establish a national postdoctoral research workstation, selected for the National Key R&D Program by China’s Ministry of Science and Technology, and certified as a specialized and innovative enterprise. Juventas has also been named a rising star in China's healthcare industry by Forbes China and recognized as an emerging force in China's medical sector by the Hurun Report. Its independently developed core CAR-T product, Yuanruida®, received approval from the National Medical Products Administration (NMPA) for market launch in November 2023. The product was acclaimed as one of the "Top 10 Advances in Chinese Medicine in 2023" by the Chinese Academy of Medical Sciences and included in the "Top 10 Progresses in China's Pharmaceutical and Biotechnology Industry in 2023" by the China Association of Biotechnology, offering patients a breakthrough treatment option.

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Dr. Lulu Lyu

Dr. Lulu Lv, CEO of Juventas, stated:

Juventas' First Core Product, Yuanruida® (Najiolunsa Injection), Selected for the List of Iconic Biomanufacturing Products by China’s Ministry of Industry and Information Technology: An Honor and Responsibility for Juventas. This recognition will inspire us to continue focusing on clinical needs, adhere to independent innovation, and enable more patients to benefit from innovative immune cell therapies such as CAR-T. Building on the approval of Najiolunsa Injection for adult acute lymphoblastic leukemia, we will accelerate its expansion into new indications like lymphoma, pediatric acute lymphoblastic leukemia, and various types of autoimmune diseases. At the same time, we will advance international product registration and collaborations, bringing China-developed CAR-T therapies to the global stage.

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About Juventas

Juventas, established in June 2018, has grown into a leading innovator in China's cell drug industry and aims to become a globally leading biopharmaceutical company driven by next-generation cell and gene technologies. The company’s first core product, Yuanruida® (Nabegalen Cel Injection, CNCT19), was officially approved for marketing by the National Medical Products Administration in November 2023. This product is the first CAR-T drug in China’s leukemia treatment field and also the first fully China-developed CD19 CAR-T drug. Juventas has formed deep collaborations with top-tier national research institutions, establishing an international new drug R&D system centered on technology platforms such as CAR and gene-editing. The company has over 10 pipeline products under development, covering diseases including hematological malignancies, solid tumors, and autoimmune disorders.

Yuanruida® (Nadiveucel Injection, CNCT19, Inaticabtagene Autoleucel Injection) is a CAR-T cell therapy product with proprietary intellectual property targeting CD19. It features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. It has successively obtained three Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for the treatment of adult relapsed or refractory acute lymphoblastic leukemia (r/r B-ALL), relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia. Additionally, it has been granted "Breakthrough Therapy Designation" by the Center for Drug Evaluation of the NMPA and Orphan Drug Designation (ODD) by the U.S. FDA. In December 2022, the NMPA officially accepted the New Drug Application (NDA) for Nadiveucel Injection for treating adult r/r B-ALL and included it in the priority review process. In March 2023, the IND application for Nadiveucel Injection for treating adult r/r B-ALL was approved by the U.S. FDA. In November 2023, Yuanruida® (Nadiveucel Injection) was officially approved for marketing by the NMPA in China.

Juventas adheres to the principle of meeting clinical needs, and through a strict cell therapy product manufacturing and quality system, provides patients with safe, effective, and accessible immune cell therapy products. The company possesses world-class R&D technology platforms, process development platforms, quality control systems, and commercial-scale production bases. In June 2021, it obtained the first-ever "Drug Manufacturing License" for cellular drugs in Tianjin, China. The company holds multiple invention patents and has been selected for the National Key Research and Development Program under the Ministry of Science and Technology’s “Technology Supporting the Economy 2020 Key Special Projects.” It has also received titles such as "National Intellectual Property Advantage Enterprise" and "Tianjin Specialized, Refined, Unique, and Innovative SME Recognition."

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