Juventas Biotech 

On September 26, 2024, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that Heyuan Biotechnology (Tianjin) Co., Ltd. (referred to as "Heyuan Biotechnology") had launched its first CAR-T cell therapy product, Yuanruida ® The application for marketing authorization for the new indication of (Nakiolenza Injection) has been officially accepted, with acceptance number CXSS2400104, for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) after second-line or above systemic therapy. This is after the recurrence or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in adults ® The second indication for submitting a new drug listing application domestically. This new drug listing application is based on a single arm, open label, multicenter critical clinical study (NCT04586478) jointly led by the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) and Ruijin Hospital affiliated with Shanghai Jiao Tong University.

Serial No. Pending No. Drug name Drug type Application type Registration classification Company Processing date
1 CXSS2400104 Inaticabtagene Autoleucel Injection Therapeutic biological product New drug 2.2 Juventas Biotechnology (Tianjin) Co., Ltd. Sept. 16, 2024

Non Hodgkin's lymphoma (NHL) is a group of malignant tumors in the lymphohematopoietic system. The incidence rate is increasing year by year. It is a blood malignant tumor that seriously endangers human life and health. Among them, diffuse large B-cell lymphoma (DLBCL) is the most common, accounting for 25%~50% [1]. DLBCL has high heterogeneity and strong invasiveness. Even with first-line treatment, 30% to 40% of DLBCL patients may still experience recurrence or be difficult to treat [2]. Once it progresses to recurrence or difficult to treat (R/R), DLBCL progresses rapidly and has a high mortality rate, with a median survival of only 6.3 months [3]. This remains a major challenge in clinical practice, and there is an urgent need to explore more effective treatment options.
Yuanruida ® (Nakiolenza Injection) is a targeted CD19 CAR-T cell therapy product independently developed by Heyuan Biotechnology. It originates from the long-term technological innovation accumulation of the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences), and has a globally unique CD19 scFv (HI19a) structure and internationally leading manufacturing process. Yuanruida ® (Nakiolenza Injection) is the first CD19 CAR-T cell therapy product with fully independent intellectual property rights in China. It has been deployed 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 multiple types of autoimmune diseases.
As the first CAR-T cell therapy product in the field of leukemia treatment in China, Yuanruida ® The indications for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia will be launched in China in November 2023. As of now, Yuanruida ® It has been recommended by multiple diagnostic and treatment guidelines, including CSCO (Chinese Society of Clinical Oncology) and the Chinese Medical Association; It has covered 80 top domestic blood disease treatment hospitals, and its real-world efficacy and safety are highly recognized by doctors and patients.
Professor Wang Jianxiang, Chief Clinical Expert of the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) and Director of the National Clinical Medical Research Center for Hematological Diseases:

Congratulations on the official acceptance of the marketing authorization application for the treatment of relapsed or refractory large B-cell lymphoma by the National Medical Products Administration (NMPA)! Nagiolanse injection is a targeted CD19 CAR-T drug independently developed by China. It has demonstrated significant clinical benefits in clinical studies and real-world clinical practices, including adult relapsed or refractory B-cell acute lymphoblastic leukemia, relapsed or refractory large B-cell lymphoma, children and adolescents relapsed and refractory acute B-cell lymphoblastic leukemia, and has also obtained very positive clinical data in the exploration of autoimmune diseases. We look forward to the continuous approval of multiple indications for Nagiolanse injection, so that more and more patients can benefit from independent treatment. Original CAR-T therapy

Dr. Lv Lulu, CEO of Heyuan Biotechnology:

Yuan Ruida ® The new drug application for treating lymphoma indications has been officially accepted by the National Medical Products Administration, which is another important milestone for Heyuan Biotechnology. We are thrilled! We are committed to achieving Yuanruida ® Maximizing clinical value, through the layout of multiple disease fields such as leukemia, lymphoma, autoimmune diseases, etc., continuously achieving the maximization of the applicable population of Nakiolenza injection, laying a solid foundation for its subsequent inclusion in national medical insurance. Yuanruida ® The indications for treating adult relapsed or refractory B-cell acute lymphoblastic leukemia have been officially approved for marketing by the National Medical Products Administration in November 2023, and the registered clinical research for treating relapsed or refractory B-cell acute lymphoblastic leukemia in children and adolescents is also progressing in an orderly manner. This time, Yuanruida ® The advancement of indications towards lymphoma will bring another important treatment option for patients, and we look forward to obtaining approval as soon as possible to reignite the hope of life for more patients