Congratulations! Ucello’s Cord Blood-Derived Allogeneic Universal CAR-T Approved by US FDA IND!

Ucello Biotechnology Co., Ltd., a key strategic partner of Yeasen Biotechnology, has independently developed a CD19-targeted chimeric antigen receptor (CAR) allogeneic universal T cell injection (UC101), which was approved by the US Food and Drug Administration (FDA) for a new drug clinical trial application (IND) on January 11, 2025. This marks the first time a universal CAR-T product from China has been approved by the FDA for new drug clinical trials.

The World's First Cord Blood-Derived Allogeneic Universal CAR-T

UC101 is the world’s first cord blood-derived allogeneic universal CAR-T product to be approved by the FDA IND. Cord blood-derived T cells, being the youngest T cells, possess natural advantages such as low immunogenicity and an early differentiation state. This low immunogenicity reduces the risk of host-versus-graft (HvGR) reactions, facilitating the expansion of allogeneic universal CAR-T cells in patients and significantly improving their in vivo retention time. Furthermore, 90% of cord blood T cells are naive T cells, with 80% remaining as Tscm and Tcm cells even after extensive in vitro expansion. These early-stage differentiated Tscm and Tcm cells exhibit enhanced expansion and persistence in vivo, leading to improved therapeutic outcomes.

Yeasen Biotechnology Congratulates Ucello on This Milestone!

Yeasen Biotechnology extends its heartfelt congratulations to Ucello for reaching this important milestone. In this project, Yeasen Biotechnology provided essential products and technical services, including the HEK293 host cell DNA residue detection kit, which met all application requirements. This HEK293 DNA residue detection kit was fully validated according to Chp, USP, ICHQ2 (R1), and other standards, ensuring compliance with both Chinese and international regulations and authoritative organizations. This collaboration played a crucial role in helping secure FDA approval for the clinical trial application of this project.

About Ucello

Ucello Biotechnology Co., Ltd. was founded in December 2020 with a focus on the research, development, and commercialization of allogeneic universal CAR-T cell therapy drugs. The company is recognized as a national technology-based small and medium-sized enterprise, a “specialized, refined, and innovative” enterprise in Sichuan Province, a “potential” unicorn enterprise in Chengdu, and a high-level talent enterprise in the High-tech Zone. Since its establishment, the company has been dedicated to addressing unmet clinical needs, and its independently developed "allogeneic universal CAR-T cell engineering transformation technology" has shown promising efficacy and safety in IIT clinical trials for blood cancers and autoimmune diseases. This technology won the "National Disruptive Technology Innovation Competition" organized by the Torch Center of the Ministry of Industry and Information Technology. Looking ahead, the company plans to accelerate industrialization, establish an "independent research and development production chain," and overcome core technical challenges, aiming to become a leading player in allogeneic universal CAR-T technology.

Yeasen Biotechnology's Related Products:

• HEK293 Host Cell DNA Residue Detection Kit

About Yeasen Biotechnology

Yeasen Biotechnology (Shanghai) Co., Ltd. is a high-tech enterprise specializing in upstream core raw materials for the life sciences industry. The company is involved in the research, development, production, and sales of three main categories of biological reagents: molecules, proteins, and cells. Their core products cover a wide range, including qPCR, NGS, reverse transcription, nucleic acid extraction and purification, PCR, molecular cloning, in vitro transcription, antibodies, protein purification, protein analysis, recombinant proteins, cell analysis, cell culture, cell transfection, and reporter gene detection, among others. These products are widely used in life science research, diagnostic testing, biomedicine, and other fields.