Novatim Immune Therapeutics Announces CDE Clearance of IND Application for KQ-2002, a Novel Enhanced Dual-Target CD19/CD22 CAR-T Therapy

Nov 26, 2024 08:27 CST Updated 08:27

Novatim

Innovative Drug Developer for Tumor Immunotherapy

Congratulations

KQ-2002 Approved

On November 25, 2024, according to the CDE official website, KQ-2002, an enhanced dual-target autologous CAR-T product targeting CD19 & CD22 independently developed by Novatim Immune Therapeutics (Zhejiang) Co., Ltd., is proposed for use in treatment.Adult Relapsed/Refractory Acute B Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma,Has obtained the clinical trial implied permission from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).

About KQ-2002

About KQ-2002

KQ-2002It is based on the company's independently developed core technology—an enhanced dual-target CAR-T platform—and the self-developed CD19&CD22 enhanced dual-target autologous CAR-T product.Focusing on adult relapsed/refractory acute B lymphoblastic leukemia and relapsed/refractory B-cell non-Hodgkin lymphoma,Combination therapy targeting CD19 and CD22 can cover various cellular subpopulations in patients with primary and relapsed B-cell malignant hematological tumors, bringing new therapeutic hope and deep, long-lasting treatment effects to patients.

About Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

About Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Founded in 2018, Novatim Immune Therapeutics (Zhejiang) Co., Ltd. is a biotechnology enterprise focused on the research and development of innovative drugs for cancer immunotherapy and their clinical applications. Based on clinical needs and differentiation, the company is committed to efficient and groundbreaking R&D innovation by establishing three major R&D platforms: bispecific antibody platform, nano-bispecific ADC platform, and enhanced dual-target CAR-T platform. It has independently developed over 10 novel and differentiated potential FIC/BIC pipelines from scratch.

Based on the bispecific antibody platform, the company has independently developed China's first βγ-biased PD1/IL2 fusion protein, which is currently in Phase Ib clinical trials in China as a monotherapy or in combination with PD-L1 monoclonal antibody, and has also obtained IND approval in the United States; based on the nano bispecific ADC platform, the company has independently developed the world’s first nano bispecific ADC, which is about to obtain IND approvals in both China and the United States; based on the enhanced dual-target CAR-T platform, the company has independently developed the world’s first dual-target CAR-T with a parallel-enhanced structure, which is currently in clinical Phase I/IIa.

E.N.D

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