Heyuan Bio's CAR-T Therapy Najeocabtagene Receives CDE Acceptance for Second Indication in Relapsed/Refractory Large B-Cell Lymphoma

On September 26, the CDE website showed that Juventas' first CAR-T cell therapy productNaciorl Injection（Yuan Ruida®）The new indication marketing authorization application has been officially accepted.（CXSS2400104） ，For the treatment of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy（r/r LBCL）。

Source of the image: CDE official website

This is a follow-up to adult relapsed or refractoryB-cell Acute Lymphoblastic Leukemia (r/r B-ALL)Subsequently, Juventas submitted a new drug marketing application in China.The Second Indication。

This new drug marketing application is based on a single-arm, open-label, multi-center pivotal clinical study.（NCT04586478）。

Non-Hodgkin's Lymphoma (NHL) is a group of malignant tumors of the lymphohematopoietic system, with an increasing incidence rate year by year. It is a hematologic malignancy that seriously endangers human life and health. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype, accounting for approximately 25%-50%. DLBCL is highly heterogeneous and aggressive. Even after first-line treatment, 30%-40% of DLBCL patients may relapse or become refractory. 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, remaining a significant clinical challenge. More effective treatment options are urgently needed.

Nacaoerensai is a CD19 CAR-T cell therapy product independently developed by Juventas, and it is also the first CD19 CAR-T cell therapy product with full independent intellectual property rights in China.Have been deployed in 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....and multiple other indications.

In November 2023, it was approved for use in China.Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.

As of now,NaciorlcelRecommended by multiple diagnosis and treatment guidelines such as CSCO and the Chinese Medical Association; already covered 80 top hematology treatment hospitals in China, with real-world efficacy and safety highly recognized by doctors and patients.

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