He Yuan Bio Announces Third IND Approval in Autoimmune Diseases for Najiolen Cell Injection to Treat Refractory Lupus Nephritis

As of now,Juventas' Naciorl Injection has obtained 3 IND approvals in the field of autoimmune disease treatment....specifically targeting immune thrombocytopenia associated with systemic lupus erythematosus (SLE-ITP), autoimmune hemolytic anemia (AIHA), and the recently approved refractory lupus nephritis (LN). This also marks the seventh clinical approval globally for the drug Naciaurolsen Injection.

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease that affects multiple systems and organs throughout the body. The main clinical features include alternating periods of disease remission and acute flare-ups, as well as the presence of numerous autoantibodies. Without timely treatment, irreversible damage to the affected organs can occur, ultimately leading to patient death. The etiology of SLE is complex and involves various factors such as genetics, sex hormones, and environmental factors (e.g., viral and bacterial infections). It is estimated that the global incidence rate of SLE is 5.14 (1.4-15.13) per 100,000 people annually, while the incidence rate in China is 14.09 per 100,000 people annually.

Lupus Nephritis (LN) is kidney damage caused by Systemic Lupus Erythematosus (SLE), and it is one of the most common visceral involvement manifestations as well as an important factor affecting patient prognosis. In China, nearly half of SLE patients develop LN, a rate higher than that in Caucasians. It is the most common secondary immune glomerular disease in China and one of the leading causes of end-stage renal disease (ESRD). LN is also a significant cause of mortality in SLE patients. Currently, the treatment of SLE-LN still faces many challenges, as some patients respond poorly to conventional therapies, indicating unmet clinical needs.

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Professor Zeng Xiaofeng

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, leading to strong heterogeneity in the condition and high demand 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. Systemic lupus erythematosus is a systemic autoimmune disease that causes various kidney-related issues, including problems in the kidneys, nervous system, and blood system, all of which can lead to life-threatening conditions. The recent implied clinical approval of Naciorlen Injection for SLE-LN once again demonstrates the potential of CAR-T cell therapy and indicates that SLE treatment is moving towards diversification, with broad prospects for future therapies.

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Professor Li Mengtao

Professor Mengtao Li, Department of Rheumatology and Immunology, Peking Union Medical College Hospital:

Systemic Lupus Erythematosus Patients in China Present with a Large Population, Severe Conditions, Heavy Disease Burden, High Complication Rates, and Serious Impact on Fertility. We are very pleased to see the approval of the clinical trial for the new drug Naciorlucel for refractory lupus nephritis. The multi-disciplinary 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.

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Professor Wang Jianxiang

Blood Disease Hospital, Chinese Academy of Medical Sciences(Institute of Hematology, Chinese Academy of Medical Sciences)Chief Clinical Expert and Director of the National Clinical Research Center for Hematological Diseases, Professor Wang Jianxiang：

Warm congratulations on the implied permission for the new drug clinical trial of China's self-developed CD19 CAR-T drug, Najiolumab Injection, for the treatment of refractory lupus nephritis! As a representative of China's fully independent intellectual property CAR-T therapy, Najiolumab Injection has demonstrated excellent efficacy in the field of hematological tumors such as leukemia and lymphoma, and has shown breakthrough potential in autoimmune diseases. We look forward to this innovative therapy achieving more progress and success in clinical research, promoting the role of CAR-T therapy in a wider range of disease areas.

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Dr. Lulu Lyu

CEO of Juventas, Dr. Lulu Lv:

Within a month, Juventas' Najiolumab Injection (Trade Name: Yuanruida)^®) has obtained two new IND approvals in the field of autoimmune diseases, once again demonstrating the therapeutic potential and clinical value of its products. Autoimmune diseases are a key focus for Juventas, and currently, the company has established a robust pipeline of candidate products for multiple indications, including SLE-ITP, AIHA, and SLE-LN. It is anticipated that the injection of Naciorlen will fulfill significant unmet needs across more disease areas, offering patients more innovative cell therapy options.

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