Juventas Bio Announces First-Ever Data from Inaticabtagene Autoleucel in Autoimmune Hemolytic Anemia, Adult and Pediatric r/r B-ALL at ASH 2024, Alongside Early-Stage Dual-Targeting CAR-T and Super-γδ T Cell Therapy Results

• The meeting will announce for the first time in an oral report format the data results of CD19 CAR-T (Nagiolun Race Injection) in treating refractory autoimmune hemolytic anemia.

• The meeting will present updated key clinical data on the treatment of adult relapsed/refractory acute B lymphoblastic leukemia with Naciorlen Cell Injection in a poster format.

• The conference will publish the abstract summarizing the efficacy and safety data results of Nakiolumab injection in treating children with relapsed or refractory acute B lymphoblastic leukemia.

• The meeting will present early research data on CD19/BCMA dual-target and Super-Γδ T cell therapy in the form of a poster.

• This conference featured a total of five research achievements, systematically showcasing the various developments in research and clinical progress for the company's core products and pipeline products.

Juventas, established in June 2018, has grown into a leading innovator in China's cell therapy industry and aims to become a global leader in the new generation of biopharmaceuticals driven by cutting-edge cell and gene technologies. The company’s first proprietary CAR-T product, Yuan Ruida® (Nageoaurine Injection), received official approval for its New Drug Application (NDA) from the National Medical Products Administration in November 2023. This marks the first CAR-T drug in China’s leukemia treatment field and the first fully self-innovated CD19 CAR-T drug developed in China. It was granted the designation of "Breakthrough Therapy" and included in the "Priority Review Process" by the National Medical Products Administration, as well as receiving "Orphan Drug" status from the U.S. FDA. In addition to being approved for treating adult patients with relapsed or refractory acute lymphoblastic leukemia, clinical research and new drug approval processes are also underway for Yuan Ruida® in treating relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia, and autoimmune diseases.

Yuanruida® (Najiolunsa Injection, CNCT19 Injection, Inaticabtagene Autoleucel Injection) is a CAR-T cell therapy product targeting CD19 with independent intellectual property rights. It features a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing processes. It has been granted the "Breakthrough Therapy Designation" by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) and Orphan Drug Designation (ODD) by the U.S. FDA. In December 2022, the NMPA officially accepted the New Drug Application (NDA) for Najiolunsa Injection for the treatment of adult r/r B-ALL and included it in the priority review process. In March 2023, the Investigational New Drug (IND) application for Najiolunsa Injection for the treatment of adult r/r B-ALL was approved by the U.S. Food and Drug Administration (FDA). In November 2023, Yuanruida® (Najiolunsa Injection) was officially approved for marketing by the NMPA in China.

Juventas closely collaborates with top national institutions such as the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, to build an international new drug research and development system centered on technology platforms including CAR, iPSCs, and gene editing. It has over 10 pipeline products under research, covering multiple disease areas such as hematological tumors, solid tumors, autoimmune diseases, and regenerative medicine.

Guided by clinical needs, the company is committed to creating safe, efficient, and accessible immune cell therapy products for patients through a strict production and quality system for cell therapy products. Juventas boasts 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 Production License" for cell-based drugs in Tianjin, China. The company holds multiple invention patents, has been honored as a "National Intellectual Property Advantage Enterprise," approved to establish a national postdoctoral research workstation, and selected for the National Key Research and Development Program of the Ministry of Science and Technology of China under the "Science and Technology Supporting Economic 2020 Key Special Project."

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