Heyuan Biosciences Presents First Real-World Evidence of Inaticabtagene Autoleucel (NaJiAolunSai Injection, Brand: Yuanruida®) at ASCO and EHA 2025

Jun 17, 2025 14:30 CST Updated 14:30

Juventas

Innovative Cell Therapy Drug Developer

SimbayPark Star North · FT Account No.1 Park Enterprise JuventasThe CAR-T innovative cell therapy product independently developed —— Najiolumab Injection (Trade name: Yuan Ruida)^®）The First Real-World Research Achievement Makes a Brilliant Debut2025YearASCOAndEHAConference，This isChina's First LeukemiaCAR-TFirst Report on Real-World Data of Cell Therapy Products. Presented at the conference in the form of a poster (ASCO Poster Abstract No.: 6529; EHA Poster Abstract No.: PF379).

ASCO and EHA Posters

As of April 24, 2025, 164 patients underwent leukapheresis, and 97 patients subsequently received injections of Naciorlumab and obtained evaluable efficacy and safety results.

Breakthrough Objective Response Rate (ORR) and long-term survival rate:Data as of April 30, 2025,Median Follow-up6.2Months,3Within monthsORRFor92.8%，3Relief of minimal residual disease (MRD) in patients within months (MRD) The negative rate reached100%The median duration of response (DOR), overall survival (OS), and relapse-free survival (RFS) have not yet been reached.Estimated all patients1Year'sOSAs high as90%。

Excellent Safety:In this study,Grade 3 or higher cytokine release syndrome (CRS）and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) The incidence rates are all2.1%No deaths occurred due to CRS or ICANS.

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Dr. Lulu Lyu

Dr. Lulu Lv, CEO of Juventas, emphasized:

Naciorlen Injection (Trade Name: Yuan Ruida)^®) is a CAR-T cell product independently developed in China. Relying on its unique CD19 scFv warhead, CAR-T structure, and process design, it can precisely identify and target tumor cells. It features high efficiency, low toxicity, a single infusion, and sustained effectiveness, providing a breakthrough treatment for acute lymphoblastic leukemia. The findings from this real-world study further validate that the Naciorlen Cell Injection possesses clinical advantages of "high remission, sustained remission, and safety controllability." In this real-world study, the application of Naciorlen Cell Injection has gradually moved to earlier stages, enhancing the efficacy of CAR-T cell therapy while further reducing the incidence of CAR-T cell therapy-related adverse reactions such as CRS and ICANS. It is a great honor to present the latest research results of Naciorlen Cell Injection at top international academic conferences like the 2025 ASCO and EHA. The remarkable efficacy and safety data of Naciorlen Cell Injection in real-world studies highlight the outstanding capabilities of China's innovative pharmaceutical companies, giving Juventas greater confidence and motivation to focus on product development in the field of cell therapy. Juventas will continue to innovate in the field of cell therapy, achieving new breakthroughs continuously, to provide more high-quality cell therapy products for patients in China and worldwide, creating new life and a high-quality existence for more patients suffering from diseases.

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About Juventas

Juventas, founded in June 2018, has grown into a leading innovator in China's cell therapy industry, committed to becoming a globally leading biopharmaceutical enterprise driven by next-generation cell and gene technologies.

The Company's First Core Product: Yuanruida^®(Najiolun 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 self-innovated CD19 CAR-T drug in China. Juventas has deeply cooperated with top national institutions to build an international new drug research and development system centered on technology platforms such as the CAR technology platform and gene editing technology platform, with more than 10 pipeline products under research covering diseases such as hematological tumors, solid tumors, and autoimmune diseases. Yuan Ruida^®(Inaticabtagene Autoleucel Injection, CNCT19) 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 r/r B-cell acute lymphoblastic leukemia. It has also received the "Breakthrough Therapy Designation" from the Center for Drug Evaluation of the NMPA and Orphan Drug Designation (ODD) from the U.S. FDA. In December 2022, the NMPA officially accepted the New Drug Application (NDA) for Inaticabtagene Autoleucel Injection for the treatment of adult r/r B-ALL and granted it priority review. In March 2023, the IND application for Inaticabtagene Autoleucel Injection for the treatment of adult r/r B-ALL was approved by the U.S. Food and Drug Administration (FDA). In November 2023, Juventas...^®(Najiolun Injection) Officially Approved for Marketing by China's National Medical Products Administration (NMPA).

Guided by clinical needs, the company is committed to creating safe, efficient, and accessible immune cell therapy products for patients through a strict cell therapy product manufacturing and quality system. Juventas boasts world-class R&D technology platforms, process development platforms, quality control systems, and commercial production bases. In June 2021, it obtained the first-ever "Drug Manufacturing License" for cell-based drugs in Tianjin, China. The company holds multiple invention patents and has been selected for the National Key R&D Program of the Ministry of Science and Technology of China under the “Technology Supporting the Economy 2020 Key Special Projects.” It has also received titles such as "National Intellectual Property Advantage Enterprise" and "Tianjin City's Specialized, Precise, Unique, and Innovative SME Certification."

About SimbayPark

Shanghai FT1 Life Science Park (Abbreviation"Simbay Park, Star North · Free Trade Zone No.1") is located in the Waigaoqiao Bonded Area, the core of Shanghai's Pudong New Area Free Trade Zone. It is an innovative service-oriented characteristic industrial park under the Star North Group, focusing on the incubation, cultivation, and transformation of medical enterprises.The park relies on the unique advantages of an "FTZ + bonded" outward-oriented economic zone. By gathering the entire industrial chain service resources of CRO+CDMO+CSO+EHS in the biopharmaceutical field, government innovation and entrepreneurship support policies, and numerous well-known investment institutions, it provides enterprises with truly in-depth technical incubation in the medical industry. It acts as a steward for corporate technology transfer achievements, striving to create an international biopharmaceutical industry innovation and entrepreneurship base.