Two Blockbuster Therapies Approved in China: Inaticabtagene Autoleucel and Glofitamab

Nov 09, 2023 17:13 CST Updated 17:13

Juventas

Innovative Cell Therapy Drug Developer

On November 8, the NMPA announced,Through the Priority Review and Approval Procedure with ConditionsApproved SeparatelyNaciorl Injection declared by Juventas Biotechnology (Tianjin) Co., Ltd.(Product name: Yuan Ruida),Gefitumab Injection Submitted by Roche Pharma (Schweiz) AG(Product name: Gao Luohua/Columvi) launched.

NirabotulinumtoxinA Injection is used to treat adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) and is the first CAR-T product approved for marketing in China for the treatment of leukemia.

Gefitumab Injection is used to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma who have previously received at least two lines of systemic therapy.

Original text as follows:

Recently, the National Medical Products Administration (NMPA) has granted conditional approval for the listing of Nirocaben Autologous Injection (brand name: Yuanruida) submitted by Juventas Biotechnology (Tianjin) Co., Ltd. through the priority review and approval process. This drug is used to treat adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Naciaurolen Injection is an autologous T-cell immunotherapy product prepared by using gene modification technology to express a chimeric antigen receptor (CAR) targeting CD19 on the surface of T cells. After infusion into the body, it binds to target cells expressing CD19, activates downstream signaling pathways, induces CAR-T cell activation and proliferation, and exerts cytotoxic effects on the target cells.

The market launch of this product provides a new treatment option for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Recently, the National Medical Products Administration (NMPA) has granted conditional approval for the listing of Glofitamab Injection (brand name: Columvi), submitted by Roche Pharma (Schweiz) AG via the priority review and approval process. It is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who have previously received at least two lines of systemic therapy.

Glofitamab Injection is a bispecific antibody that simultaneously binds to CD20 on the surface of B cells and CD3 on the surface of T cells, mediating the formation of immune synapses, subsequently inducing T-cell activation and proliferation, cytokine secretion, and release of cytolytic proteins, thereby leading to the lysis of CD20-expressing B cells.

The market launch of this product provides a new treatment option for adult patients with relapsed or refractory diffuse large B-cell lymphoma.