Chengdu YouSaiNuo's Umbilical Cord Blood-Derived Allogeneic CAR-T Therapy UC101 Receives CDE IND Acceptance in China Following FDA Approval

Recently,UCELLOThere isUCELLO's self-developed "UC101 CAR-T Cell Injection" Receives Approval from the Center for Drug Evaluation of the National Medical Products Administration（CDE）Acceptance, officially launching the clinical trial application process in China!

This follows the approval by the U.S. FDA for a new drug clinical trial on January 11, 2025.（IND）Another milestone progress after approval, marking that the "Chengdu High-Tech Made" innovative drug has achieved dual-driven success in global layout and local clinical transformation, bringing a more cost-effective new treatment option for cancer and autoimmune disease patients in China and even globally.

UC101 is the world's first umbilical cord blood-derived allogeneic universal CAR-T to receive FDA IND approval.Umbilical cord blood-derived T cells are the youngest T cells, with the natural advantages of low immunogenicity and being in an early stage of differentiation. The low immunogenicity of umbilical cord blood T cells can reduce host-versus-graft.（HvGR）Response, making allogeneic universal CAR-T easier and better to expand in patients, significantly increasing the median in vivo persistence time of allogeneic CAR-T cells. More importantly, 90% of umbilical cord blood T cells are naïve T cells, and after extensive in vitro expansion, 80% of them remain as Tscm and Tcm cells. Tscm and Tcm cells, which are at an early stage of differentiation, exhibit stronger in vivo expansion capacity and persistence, resulting in better therapeutic effects of the product.

UC101 is also the world's first CAR-T to use a stable cell line for lentiviral vector production and receive IND approval. Lentiviral vector production using stable cell lines does not require plasmids as raw materials, making the production process simpler.The lentiviral vectors produced under this process have the advantages of high batch-to-batch consistency, high viral titer, low empty capsid rate, high transduction efficiency, and more controllable quality. Compared with lentiviral vectors produced by traditional transient transfection processes, this method significantly reduces costs while improving quality.

UC101 employs a unique gene-editing combination, which reduces immunogenicity and enhances efficacy while better controlling adverse reactions. In this FDA IND application, the company successfully utilized imported American umbilical cord blood to complete multiple large-scale production batches in a GMP environment. A single batch can provide over 100 doses, significantly reducing the cost of CAR-T cell therapy and improving medical accessibility.

Editorial Responsibility | Yong

Proofread by Jiebolian |

References:

1.https://mp.weixin.qq.com/s/sglSFrk-tiRot4SN67R9OA

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