Heyuan Biosciences' Nacelorcabtagene Injection Receives Second NMPA Approval for Dual Indications in Leukemia and Lymphoma

Recently, Juventas announced that its self-developed CAR-T cell therapy product, Nalkio Cell Injection (brand name: Yuan Ruida),^®) The new drug has been approved by the China National Medical Products Administration (NMPA) for marketing.Used for treatmentRelapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy。

This is the second new drug marketing approval for Naciorl Injection in China, following its approval in November 2023 for the treatment of adult relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). This marks the first CD19 CAR-T product with full independent intellectual property rights in China, becomingCurrently the only CAR-T cell therapy product in China that covers two major hematological tumor indications: leukemia and lymphoma.。

Lymphoma is one of the most common malignant tumors of the hematological system, and large B-cell lymphoma (LBCL) is the most common type of adult non-Hodgkin lymphoma (NHL). After first-line treatment, about 40% of patients will experience progression or relapse. These patients have a poor prognosis, posing significant challenges in clinical treatment. The approval of this new indication is based on the positive results from a single-arm, open-label, multi-center pivotal Phase II clinical study (NCT04586478) of Naciauclel Injection for the treatment of r/r LBCL.

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