On November 25, 2024, according to the official website of the Center for Drug Evaluation (CDE), KQ-2002, an autologous CAR-T product targeting CD19 and CD22 developed independently from Novatim, which is intended for the treatment of adult relapsed/refractory acute B lymphoblastic leukemia and relapsed/refractory B-cell non-Hodgkin's lymphoma, has been granted approval for clinical trials by the National Medical Products Administration's Center for Drug Evaluation (CDE).
KQ-2002
KQ-2002 is based on the company's independently developed core technology - the enhanced dual-target CAR-T platform. It independently develops CD19 & CD22 enhanced dual-targeted autologous CAR-T products, focusing on adult patients with relapsed/refractory acute B lymphocytic leukemia and relapsed/refractory B-cell non-Hodgkin's lymphoma. It conducts combined treatment targeting the CD19 and CD22 targets, which can cover various cell subgroups of primary and relapsed B-cell malignant hematological tumors, bringing new treatment hope and deep and lasting therapeutic effects to patients.
Novatim
Novatim Immune Therapeutics (Zhejiang) Co., Ltd. was established in 2018. It is a biopharmaceutical technology enterprise specializing in the research and development of innovative drugs for tumor immunotherapy. Based on clinical needs and differentiation, it is committed to establishing three research and development platforms: dual-function antibody platform, nano-bispecific ADC platform, and enhanced dual-target CAR-T platform. It independently developed over 10 novel and differentiated potential FIC/BIC pipelines.
Based on the dual-functional antibody platform, Novatim independently developed the first βγ-biased PD1/IL2 fusion protein in China. Currently, the PD1/IL2 antibody is in Phase Ⅰb clinical trial in China, and has also obtained IND approval in the United States. Based on the nano-bispecific ADC platform, Novatim independently developed the world's first nano-bispecific ADC, and both China and the United States have obtained IND approval. Based on the enhanced dual-target CAR-T platform, Novatim independently developed the world's first parallel enhanced structure dual-target CAR-T, which is currently in clinical Phase Ⅰ/Ⅱa.
