Heyuan Bio's CD19-Targeted CAR-T Therapy Receives CDE Clearance for New Autoimmune Indication

Oct 12, 2024 07:21 CST Updated 07:21

Juventas

Innovative Cell Therapy Drug Developer

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October 12, 2024

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On October 11, Juventas announced its first self-developed CAR-T cell therapy product, Yuan Ruida.^®(Juventas' Naciorl Injection) has obtained tacit approval for a new Investigational New Drug (IND) application in the field of autoimmune diseases, intended forTreatment of Refractory Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia (SLE-ITP)This is the first Investigational New Drug (IND) approval for Naciorlson Injection in the field of autoimmune disease treatment.

Systemic Lupus Erythematosus (SLE) is a chronic systemic autoimmune disease that often causes damage to multiple organs throughout the body. Abnormal B-cell activity and the production of autoantibodies play a crucial role in its pathogenesis. SLE can lead to immune thrombocytopenia, which occurs in approximately 16% of Chinese patients with SLE. A significant proportion of these patients show poor responses to glucocorticoids, immunosuppressants, and biologics, resulting in poor prognosis and a long-term risk of major organ bleeding, representing a major challenge in the treatment of SLE.

In July this year, the international top journal "New England Journal of Medicine" (NEJM, IF: 96.2) published online a research paper by Professor Zeng Xiaofeng and Professor Li Mengtao from the Department of Rheumatology and Immunology, Peking Union Medical College Hospital, and Professor Zhou Daobin from the Department of Hematology, titled "Anti-CD19 CAR T cells in refractory immune thrombocytopenia of SLE". The study focused on the use of a CD19-targeted chimeric antigen receptor autologous T-cell (CD19 CAR-T) injection (Narigenles Injection) for the treatment of systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP).The report demonstrates the good and lasting efficacy and safety of Naciorlence Cell Injection in systemic lupus erythematosus (SLE) and immune thrombocytopenia (ITP), highlighting the potential application of CAR-T in the treatment of SLE and ITP.

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Yuan Ruida^®(Natiluxen-cel Injection) is a CD19-targeted CAR-T cell therapy product independently developed by Juventas, stemming from the long-term technological innovation accumulation of the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences. It features a globally unique CD19 scFv (HI19a) structure and internationally leading production and manufacturing processes. Yuanruida^®(Natco Relin Injection) isThe First CD19 CAR-T Cell Therapy Product with Full Independent Intellectual Property Rights in China. It has been developed for multiple indications, including 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 various types of autoimmune diseases. The new drug application for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia was officially approved by the National Medical Products Administration (NMPA) in November 2023, and the new drug application for treating relapsed or refractory large B-cell lymphoma was formally accepted by the NMPA in September 2024.

As the first CAR-T cell therapy product in China's leukemia treatment field, Yuan Rui Da^®Post-marketing, it has been recommended by several authoritative diagnosis and treatment guidelines, such as CSCO (Chinese Society of Clinical Oncology) and the Chinese Medical Association; it has been adopted by 80 top hematology treatment hospitals in China, with its real-world efficacy and safety highly recognized by doctors and patients.

Professor Mengtao Li from the Department of Rheumatology and Immunology at Peking Union Medical College Hospital: "In our exploratory clinical study using Naciaurelase Injection to treat refractory systemic lupus erythematosus-associated immune thrombocytopenia, we have successfully treated multiple patients, with the first patient achieving sustained remission for over a year. We presented this world-first application of CD19 CAR-T cell therapy in treating systemic lupus erythematosus-associated immune thrombocytopenia in The New England Journal of Medicine. We are very pleased to see the approval of the clinical trial for Naciaurelase as a new drug to treat refractory systemic lupus erythematosus-associated thrombocytopenia. The multidisciplinary team at Peking Union Medical College will continue to explore and expand the application of CAR-T cell therapy in this disease, advancing the field of autoimmune disease treatment and benefiting more patients."

Dr. Lulu Lv, CEO of Juventas: "We are extremely excited about the approval of the new drug clinical trial for Najiolumab Injection in treating refractory systemic lupus erythematosus with thrombocytopenia. This means that after the layout of Najiolumab Injection in treating adult relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory large B-cell lymphoma, and relapsed or refractory B-cell acute lymphoblastic leukemia in children and adolescents, its expansion into a new area of autoimmune diseases has also entered a new stage."In addition to the recently approved IND for refractory systemic lupus erythematosus with immune thrombocytopenia (SLE-ITP), the injectable drug Naciorlen is also undergoing investigator-initiated clinical studies and IND applications for various types of autoimmune diseases, including lupus nephritis and autoimmune hemolytic anemia."We will accelerate the clinical research and application of Naciorlen Cell Injection in various autoimmune diseases, with the hope that more patients can benefit from this innovative therapy."

Juventas, founded in June 2018, has grown into a leading innovator in China's cell therapy industry, striving to become a globally recognized biopharmaceutical company driven by cutting-edge cell and gene technologies. The company’s first independently developed CAR-T product is Yuan Ruida.^®The New Drug Application (NDA) for (Najiolun Cell Injection) was officially approved 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 developed in China. It was successively included by the National Medical Products Administration in the category of "Breakthrough Therapy Designation" and "Priority Review Procedure," and received the U.S. FDA’s "Orphan Drug" designation. In addition to the already approved indication for treating adult relapsed or refractory acute lymphoblastic leukemia, Yuanruida...^®Clinical research and new drug marketing for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, relapsed or refractory B-cell acute lymphoblastic leukemia in children and adolescents, and autoimmune diseases are also proceeding in an orderly manner.

References：

1. https://mp.weixin.qq.com/s/9-w9DlWNPKFMdZ8KjxGz7g

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