Heyuan Bio's Yuanruida® (Najiorunsa Injection) Receives Formal Acceptance for New Indication NDA to Treat Relapsed or Refractory Large B-Cell Lymphoma
Juventas
Innovative Cell Therapy Drug Developer
On September 26, 2024, information disclosed on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed:Xingbei·FTO No.1 Park Enterprise Juventas (Tianjin) Co., Ltd. (referred to as "Juventas")The First CAR-T Cell Therapy ProductYuan Ruida®The new indication marketing authorization application for (Najiolun Injection) has been officially accepted., Application No. CXSS2400104,For the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapyThis is the second indication for which Yuanruida® has submitted a new drug marketing application in China, following adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The submission of this new drug application is based on a single-arm, open-label, multi-center pivotal clinical study (NCT04586478) jointly led by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Ruijin Hospital affiliated with Shanghai Jiao Tong University.
Non-Hodgkin lymphoma (NHL) is a group of malignant tumors of the lymphohematopoietic system, with an increasing incidence rate year by year. It is a serious hematologic malignancy that endangers human life and health. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype, accounting for approximately 25%-50% [1]. DLBCL exhibits high heterogeneity and strong invasiveness; even after first-line treatment, 30%-40% of DLBCL patients may relapse or become refractory [2]. Once progressed to relapsed or refractory (R/R) DLBCL, the disease advances rapidly with a high mortality rate, and the median survival time may be only 6.3 months [3], remaining a significant clinical challenge that urgently requires exploration of more effective treatment options.
Yuanruida® (Najiolunsa Injection) is a CD19-targeted CAR-T cell therapy product independently developed by Juventas Biotechnology. It originates from the long-term technological innovation accumulation of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS). It features a globally unique CD19 scFv (HI19a) structure and internationally leading production technology. Yuanruida® (Najiolunsa Injection) is the first CD19 CAR-T cell therapy product with full independent intellectual property rights in China. Its indications cover adult relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory large B-cell lymphoma, pediatric relapsed or refractory B-cell acute lymphoblastic leukemia, and multiple types of autoimmune diseases.
As the first CAR-T cell therapy product in China's leukemia treatment field, Yuanruida® was launched in China in November 2023 for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. To date, Yuanruida® has been recommended by several clinical guidelines, including those from CSCO (Chinese Society of Clinical Oncology) and the Chinese Medical Association; it has been made available in 80 top hospitals specializing in hematological disease treatment across China, with its real-world efficacy and safety highly recognized by both doctors and patients.
Professor Wang Jianxiang, Chief Clinical Expert of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS) and Director of the National Clinical Research Center for Hematological Diseases：
"Congratulations on the formal acceptance by the National Medical Products Administration (NMPA) of the marketing authorization application for a new indication of Naciorlence Injection in treating relapsed or refractory large B-cell lymphoma! Naciorlence Injection is a CD19-targeted CAR-T drug independently developed in China. It has demonstrated significant clinical benefits in clinical research and real-world clinical practice, including in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory large B-cell lymphoma, and children and adolescents with relapsed or refractory B-cell acute lymphoblastic leukemia. Additionally, it has shown highly positive clinical data in exploratory clinical studies related to autoimmune diseases. We look forward to the continuous approval of multiple indications for Naciorlence Injection, allowing more and more patients to benefit from domestically developed CAR-T therapies."
Professor Wang Jianxiang, Chief Clinical Expert of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (CAMS) and Director of the National Clinical Research Center for Hematological Diseases：
"Congratulations on the formal acceptance by the National Medical Products Administration (NMPA) of the marketing authorization application for a new indication of Naciorlence Injection in treating relapsed or refractory large B-cell lymphoma! Naciorlence Injection is a CD19-targeted CAR-T drug independently developed in China. It has demonstrated significant clinical benefits in clinical research and real-world clinical practice, including in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory large B-cell lymphoma, and children and adolescents with relapsed or refractory B-cell acute lymphoblastic leukemia. Additionally, it has shown highly positive clinical data in exploratory clinical studies related to autoimmune diseases. We look forward to the continuous approval of multiple indications for Naciorlence Injection, allowing more and more patients to benefit from domestically developed CAR-T therapies."
Dr. Lulu Lv, CEO of Juventas:
"The new drug marketing application for Yuanruida® in the treatment of lymphoma has been officially accepted by the National Medical Products Administration, marking another significant milestone for Juventas. We are truly excited! We are committed to maximizing the clinical value of Yuanruida®, expanding its reach across multiple disease areas such as leukemia, lymphoma, and autoimmune diseases, with the aim of broadening the eligible patient population for the injection of Nalorcart and laying a solid foundation for its future inclusion in China’s national medical insurance system. The indication of Yuanruida® for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia was officially approved by the National Medical Products Administration in November 2023. Registration clinical trials for treating pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia are also proceeding in an orderly manner. This advancement of Yuanruida® into lymphoma indications will provide patients with another important treatment option. We look forward to its swift approval, bringing renewed hope to more patients."
"The new drug marketing application for Yuanruida® in the treatment of lymphoma has been officially accepted by the National Medical Products Administration, marking another significant milestone for Juventas. We are truly excited! We are committed to maximizing the clinical value of Yuanruida®, expanding its reach across multiple disease areas such as leukemia, lymphoma, and autoimmune diseases, with the aim of broadening the eligible patient population for the injection of Nalorcart and laying a solid foundation for its future inclusion in China’s national medical insurance system. The indication of Yuanruida® for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia was officially approved by the National Medical Products Administration in November 2023. Registration clinical trials for treating pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia are also proceeding in an orderly manner. This advancement of Yuanruida® into lymphoma indications will provide patients with another important treatment option. We look forward to its swift approval, bringing renewed hope to more patients."
About Juventas
Juventas, established in June 2018, has grown into a leading innovator in China's cell therapy industry, striving to become a globally recognized biopharmaceutical enterprise driven by cutting-edge cell and gene technologies. The company’s first independently developed CAR-T product, Yuanruida® (Nagio-cel Injection), received official approval for its New Drug Application (NDA) from the National Medical Products Administration in November 2023. This product marks the first CAR-T drug in China’s leukemia treatment field and is also the first fully self-innovated CD19 CAR-T drug developed in China. It was designated as a "Breakthrough Therapy" by the National Medical Products Administration and included in the "Priority Review Process," while also receiving "Orphan Drug" designation from the U.S. FDA. In addition to its approved indication for treating adult relapsed or refractory acute lymphoblastic leukemia, clinical research and new drug development for Yuanruida® are progressing steadily for other indications, including 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 with proprietary intellectual property rights targeting CD19. 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 the 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 like CAR, iPSCs, and gene editing. It has over 10 pipeline products under research, covering multiple disease areas including 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 became the first company in Tianjin, China, to obtain a "Drug Manufacturing License" for cell-based drugs. The company holds multiple invention patents, has been awarded the title of "National Intellectual Property Advantage Enterprise," approved to establish a national postdoctoral research workstation, and selected for the National Key Research and Development Program under the Ministry of Science and Technology of China, specifically the "Science and Technology Supporting the Economy 2020 Key Special Project."
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 industry chain service resources of CRO+CDMO+CSO+EHS in biomedicine, government innovation and entrepreneurship support policies, and numerous well-known investment institutions, it provides enterprises with deep technical incubation within the medical industry, acting as a steward for the transformation of corporate technological achievements, while striving to create an international biomedical industry innovation and entrepreneurship base.
