Heyuan Bio Announces Naxilogene Injection Approved for New Indication in Relapsed/Refractory Large B-Cell Lymphoma

November 28,Juventas Announces Approval by China's National Medical Products Administration for the Market Launch of Its Self-Developed CAR-T Cell Therapy Product, Najiolumab Injection.For the treatment of relapsed 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 Narlakilocel 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).

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.

Nacijaolumab Injection is a CD19-targeted CAR-T cell therapy product. The approval of this new indication is based on the positive results of a single-arm, open-label, multi-center pivotal phase 2 clinical study (NCT04586478) evaluating Nacijaolumab Injection for the treatment of r/r LBCL. The study was jointly led by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, and Ruijin Hospital, Shanghai Jiao Tong University, and conducted across more than ten clinical centers in China.Key clinical research data show that Naciorlen Injection provides durable remission and long-term survival benefits for lymphoma patients, while demonstrating good safety.No cases of ≥3 grade cytokine release syndrome occurred, and only one patient developed ≥3 grade immune effector cell-associated neurotoxicity syndrome (ICANS).

References:
[1] The Marketing Approval of Naciorl Cell Injection (Yuanruida®) for Lymphoma, China-developed CAR-T Ushters in a New Era of Dual Indications. From https://www.prnasia.com/story/513962-1.shtml

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