Kaito Bio Celebrates Qihan Bio's QT-019B Receiving FDA IND Approval for Autoimmune Disease Treatment

QT-019B is an "off-the-shelf" allogeneic CAR-T cell product that can simultaneously target CD19 and BCMA, possessing the ability to precisely eliminate diseased cells through dual targeting, and reducing immunogenicity via multi-gene editing to minimize the risk of immune rejection and GvHD. In this milestone project,Catug Biotechnology Co., Ltd. undertakes the core gene editing mRNA preparation task, providing high-standard delivery that meets international clinical application requirements.

In this project, aimed at the characteristics of long fragments and complex sequence structures in gene-editing cell therapy products, Catug effectively removed double-stranded RNA and other potential immunogenic impurities by optimizing templates and transcription systems, making targeted adjustments to purification strategies, and applying its proprietary patented impurity removal process.Ultimately AchieveLinearized Plasmid Template Purity 95%, mRNA Integrity＞90%, capping rate >95%, residual dsRNA only0.003% high-quality delivery,Core parameters are stable and meet the application requirements. With a rigorous quality control system and process stability, Catug has provided a solid guarantee for the smooth progress of QT-019B.

As a CRDMO focusing on full-process services for advanced therapies, Catug Biotechnology Co., Ltd. has built a complete platform covering plasmid preparation, IVT RNA production, LNP delivery system development, and formulation filling, supported by a GMP quality management system compliant with international standards such as FDA/EMA/NMPA.Already possesses an integrated production capacity and technology layout from the early R&D stage to commercialization, providing services that coverCustomers in the broad CGT field, including in vivo and ex vivo cell therapy (including gene-edited cell therapy),The cooperation with Hangzhou Qihan Biotech Co., Ltd. not only reaffirms Catug's technical depth and delivery capabilities in the mRNA manufacturing field but also highlights the value of the CDMO model in accelerating the internationalization of innovative therapies.

In the future, Catug will continue to collaborate with global partners through its high-standard quality system, stable and reproducible production capacity, and continuously innovative process optimization. It aims to help more breakthrough therapies move from China to the world, bringing tangible health hope to patients globally.

QT-019B Cell Injection is an "off-the-shelf" allogeneic CAR-T cell product developed by Hangzhou Qihan Biotech Co., Ltd. QT-019B cells are derived from the leukapheresis products of healthy donor peripheral blood as the starting raw material, and are genetically edited to stably express two different chimeric antigen receptors (CARs), targeting CD19 and BCMA respectively, thereby enabling QT-019B to simultaneously recognize and eliminate cells expressing CD19 and BCMA.

To reduce the risk of graft-versus-host disease (GvHD), the product eliminates the expression of the T-cell receptor (TCR) through gene knockout. Meanwhile, to minimize allogeneic immune rejection, Hangzhou Qihan Biotech Co., Ltd. achieves low immunogenicity via multi-gene editing, thereby reducing the recognition and cytotoxic effects mediated by the patient's own NK cells and T cells.

Qihan Biotech is a biotechnology company that applies high-throughput gene editing technology to the fields of cell therapy and organ transplantation. Qihan aims to leverage its high-throughput gene editing technology and deep understanding of immune transplantation to develop immunologically compatible allogeneic cell therapies and xenogeneic organ treatments, bringing hope to millions of patients and their families worldwide.