Heyuan Bio's Yuandar® Receives CDE's Implicit Approval for New IND Application in Autoimmune Disease Indication
Juventas
Innovative Cell Therapy Drug Developer
Preface
Preface
On October 11, 2024, information disclosed on the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed:Daotong Family Enterprises——Juventas (Tianjin) Biotechnology Co., Ltd. (referred to as "Juventas")The New Drug Clinical Trial Application (IND) for the new indication in the field of autoimmune diseases of the first original CAR-T cell therapy product, Yuanruida® (Nagiolun Race Injection), has been granted tacit approval.(Application No.: CXSL2400450), for the treatment of refractory systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP),This is the first Investigational New Drug (IND) approval for Nakiolumab 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, posing 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. The paper, titled "Anti-CD19 CAR T cells in refractory immune thrombocytopenia of SLE", reported on the study of CD19-targeted chimeric antigen receptor autologous T-cell (CD19 CAR-T) injection (Najiolumab Injection) for treating systemic lupus erythematosus-associated immune thrombocytopenia (SLE-ITP). The report demonstrated the favorable and durable efficacy and safety of Najiolumab Injection in SLE-related immune thrombocytopenia, highlighting the potential application of CAR-T in the treatment of SLE and ITP.
Yuanruida® (Nadofarcept Injection) is a CD19-targeted CAR-T cell therapy product independently developed by Juventas, originating 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® (Nadofarcept Injection) is the 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. Its new drug application for the treatment of 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 the treatment of 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, after its launch, Yuanruida® has been recommended by several authoritative diagnosis and treatment guidelines, including those from CSCO (Chinese Society of Clinical Oncology) and the Chinese Medical Association; it has covered 80 top hematology treatment hospitals in China, with its real-world efficacy and safety highly recognized by doctors and patients.
Professor Zeng Xiaofeng, Department of Rheumatology and Immunology, Peking Union Medical College Hospital:
"Systemic lupus erythematosus (SLE) is an autoimmune disease caused by a combination of genetic, environmental, and hormonal factors, which leads to strong heterogeneity in the condition and high requirements for personalized diagnosis and treatment. The harsh reality is that in China, patients with an onset age of around 30 years old have a mortality rate exceeding 50% by the age of 55 to 60. We are highly anticipating the rapid advancement of the clinical trial for the new drug, Najiolun Sai, in treating refractory thrombocytopenia associated with systemic lupus erythematosus, to benefit the vast number of patients suffering deeply from this disease."
Professor Mengtao Li, Department of Rheumatology and Immunology, Peking Union Medical College Hospital:
"In the exploratory clinical study we conducted on the treatment of refractory systemic lupus erythematosus-associated immune thrombocytopenia with Naciorl Injection, multiple patients have been successfully treated, and the first patient has achieved 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 Naciorl as a new drug for treating refractory systemic lupus erythematosus-associated thrombocytopenia. The multidisciplinary team at Xiehe will continue to explore and deepen the application of CAR-T cell therapy in this disease, advancing progress in the field of autoimmune disease treatment to benefit more patients."
Professor Wang Jianxiang, Chief Clinical Expert of the Blood Diseases Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology of the Chinese Academy of Medical Sciences) and Director of the National Clinical Research Center for Hematological Diseases:
"Heartfelt congratulations on the approval of the new drug clinical trial for the treatment of refractory systemic lupus erythematosus thrombocytopenia with China's self-developed CD19 CAR-T drug, Nageo-lun Race Injection! Nageo-lun Race Injection has demonstrated good clinical efficacy in the field of hematological tumor treatment and has gained widespread recognition. It has also achieved positive clinical progress in exploratory clinical research related to autoimmune diseases. We look forward to the expansion and approval of more indications for Nageo-lun Race Injection, 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 thrombocytopenia. This means that after the initial focus on hematological malignancies such as treating adult relapsed or refractory B-cell acute lymphoblastic leukemia, treating relapsed or refractory large B-cell lymphoma, and treating pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia, Najiolumab Injection has now entered a new phase in expanding its application into autoimmune diseases. In addition to this approved IND indication for refractory systemic lupus erythematosus thrombocytopenia (SLE-ITP), Najiolumab Injection is also undergoing investigator-initiated clinical studies and IND submissions for various other autoimmune diseases like lupus nephritis and autoimmune hemolytic anemia. We will accelerate the clinical research and application of Najiolumab Injection across multiple autoimmune diseases with the hope of benefiting more patients through this innovative therapy."
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