Kaiti Medicine's Solid Tumor CAR-T Product KT032 Injection Receives IND Acceptance in China

2023Year6Month29Day,Focus on Solid TumorsCAR-TNanjing CART Medical Technologies, Ltd(hereinafter referred to as"Nanjing CART Medical Technologies, Ltd"）Independently developed and with independent intellectual property rightsThe IND application for the product "KT032 Cell Injection" has officially been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2300444).

KT032 Cell Injection is a novel multi-chain CAR-T developed by Nanjing CART Medical Technologies, Ltd based on the DAP-CAR platform technology, indicated for advanced ovarian cancer. The DAP-CAR platform developed by CART Medical provides natural immune receptor signals to T cells. This receptor design splits the recognition domain from the activation domain, enabling T cells to switch between coupled activation and decoupled resting states, maintaining CAR expression levels in the solid tumor microenvironment, preventing CAR-T cell exhaustion and dysfunction, thereby enhancing the anti-solid tumor efficacy of CAR-T.

 CDE Public Notice Information

Relevant data both in China and abroad show that ovarian cancer is one of the most common gynecological malignant tumors in women, with the highest mortality rate among gynecological tumors. Due to its insidious onset, about 70% of patients are diagnosed at an advanced stage. The 5-year survival rate for early-stage ovarian cancer can exceed 90%, but the prognosis for advanced ovarian cancer is poor, with a 5-year survival rate of only 30%-40%. The mortality rate of ovarian cancer ranks first among female reproductive system tumors. There is an urgent need to develop new and effective treatment methods, and CAR-T cell therapy, as a breakthrough medical technology, is expected to bring hope to patients with ovarian cancer.

Nanjing CART Medical Technologies, Ltd is a clinical-stage new drug research and development company. The company focuses on the development of novel CAR-T cell drugs for the treatment of malignant solid tumors. Relying on its advanced immune receptor library technology platform, CART Medical has successfully developed multiple pipelines for first-class new CAR-T drugs targeting malignant solid tumors. These include DAP-CAR-T, which resists the tumor microenvironment; secretory CAR-T that promotes persistence and prevents exhaustion; VIVO CAR, which enables low-cost and rapid production; TCR-T that redirects TCR signaling; and dual-epitope dual-targeting CAR-T. The company has filed 38 patent applications domestically and internationally, with four patents already authorized.

Nanjing CART Medical Technologies, Ltd was founded by Dr. Enxiu Wang, a core member of the Carl June team, which pioneered CAR-T immunotherapy, upon his return to China. The University of Pennsylvania is the cradle of CAR-T drug development. Following its pioneering and pragmatic approach, Nanjing CART is committed to the development and application of innovative proprietary drugs. Since its establishment in 2017, the company has developed four new product matrices and dozens of product pipelines focused on the "recognition, activation, carriers, and processes" of solid tumor cell therapy. Its most advanced product pipeline has now entered the rapid industrialization phase.

Innovation is the driving force of Nanjing CART Medical Technologies, Ltd., and transformation is its path to survival. Innovation, continuous innovation, keeps new technologies and products at the forefront of the field; transformation, efficient transformation, allows new technologies to quickly become new drugs that serve patients in clinical settings!