Recently, Novatim Immune Therapeutics (Zhejiang) Co., Ltd.'s wholly-owned subsidiary, Shanghai Novatim Immune Therapeutics Co., Ltd., received official approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the clinical trial application of its next-generation CAR-T product KQ-2003 autologous chimeric antigen receptor T-cell injection, which was independently developed from the ground up. The Phase I clinical study is set to be conducted at Peking Union Medical College Hospital, primarily targeting patients with relapsed/refractory multiple myeloma who have undergone three or more prior lines of therapy.

As of the approval date, there are 10 evaluable patients in the IIT study of KQ-2003 CAR-T Cell Injection for the treatment of relapsed/refractory multiple myeloma.In these 10 patients, the overall response rate (ORR) was 100%.Among them, 5 cases achieved complete remission (CR), 5 cases achieved very good partial remission (VGPR), and the longest progression-free survival (PFS) lasted for 21 months. No cytokine release syndrome (CRS) of grade 3 or higher occurred. The existing preliminary data show that the safety and efficacy of KQ-2003 CAR-T cell injection are favorable.

Dr. Guoxiang Wu, founder and chairman of Novatim, stated: "KQ-2003 CAR-T Cell Injection is a CAR-T product targeting relapsed/refractory multiple myeloma patients. In the ongoing IIT clinical research, the ORR for relapsed/refractory multiple myeloma patients reached 100%, demonstrating excellent therapeutic effects. The approval of this IND also fully reflects the CDE’s high recognition of the existing clinical trial data and the product itself. In the future, Novatim will continue to explore and develop more first-in-class or best-in-class candidate products in the field of tumor immunotherapy, providing patients with more treatment options."

About KQ-2003

KQ-2003 Autologous Chimeric Antigen Receptor T-Cell Injection is a next-generation CAR-T product independently developed from the ground up by Novatim Immune Therapeutics (Zhejiang) Co., Ltd. It can simultaneously target two therapeutic antigens, B-cell maturation antigen (BCMA) and CD19, offering new hope and deep, lasting treatment effects for more patients with relapsed/refractory multiple myeloma in the future.

About Novatim

Novatim Immune Therapeutics (Zhejiang) Co., Ltd. was established in 2018 as a biopharmaceutical technology enterprise focused on the research and development of innovative drugs for cancer immunotherapy and their clinical applications. It wholly owns Shanghai Novatim Pharmaceuticals Technology Co., Ltd. Based on clinical needs and its corporate positioning in cancer immunotherapy, the company has developed platforms for bispecific antibodies, dual-target ADC/dual-epitope ADC, CAR-T, and more, with nearly 10 FIC/BIC products in development.

Novatim's first core product independently developed from the ground up, the PD-1-targeted mutant IL-2 fusion protein — KY-0118 injection, features a unique design concept that harnesses the effects of a next-generation agonist (Next Generation Agonist). Reportedly, this product’s development progress ranks second globally in its field, just behind Roche. Clinical trials are currently underway at the General Hospital of the People's Liberation Army in China, and preliminary clinical trial data has shown promising safety and significant efficacy.