August 13, 2025 – Qihan Biotech announced that the U.S. Food and Drug Administration (FDA) has provided formal clearance of the company’s Investigational New Drug (IND) application of its proprietary, first-in-class, dual targeting CAR-T cell therapy, QT-019B. According to Qihan Biotech, QT-019B is the first universal CAR-T cell product for autoimmune diseases to receive FDA IND clearance in China. Qihan Biotech plans to initiate a Phase 1/2 clinical trial of QT-019B for refractory systemic lupus erythematosus (rSLE) in the U.S.
As Qihan Biotech’s CDMO partner, Porton Advanced extends its warmest congratulations on this milestone achievement!
To date, Porton Advanced has successfully supported clients in obtaining a total of 19 global IND approvals, including 13 from NMPA, 5 from FDA, and 1 from MedSafe. Our comprehensive CDMO solutions in cell and gene therapy, including Investigator-Initiated Trials (IIT) support and IND-enabling CMC studies, and GMP clinical supplies manufacturing , have facilitated the advancement of multiple innovative therapies from R&D through clinical stages to commercialization.
QT-019B cell injection is an allogeneic CAR-T cell therapy developed by Qihan Biotech. QT-019B cells are derived from leukapheresis products of healthy donors and genetically engineered to stably express two distinct chimeric antigen receptors (CARs) targeting CD19 and BCMA, enabling simultaneous recognition and clearance of CD19- and BCMA-expressing cells.
To mitigate graft-versus-host disease (GvHD) risk, T-cell receptor (TCR) expression is eliminated via gene knockout. Additionally, Qihan employs multiplex gene editing to reduce immunogenicity, thereby minimizing host NK- and T-cell-mediated recognition and cytotoxicity against the allogeneic product.
In investigator-initiated clinical studies in China, QT-019B has demonstrated promising efficacy in multiple refractory autoimmune diseases, including rSLE. Qihan Biotech has prioritized rSLE as the lead indication and plans to conduct a Phase 1/2 trial of QT-019B for rSLE in the U.S., with the University of Pennsylvania Hospital serving as the primary clinical site.
Qihan Biotech is a biotechnology company applying genome editing technology to develop novel cell therapies and organs for transplantation. The company's mission is to use high-throughput, multiplexable genome editing combined with expertise in transplantation immunology to create immunologically privileged allogeneic cells and xenogeneic organs for use as therapies to treat cancer, autoimmune diseases, organ failure, and other complex medical conditions. With a vision to create a world in which cell and organ therapies are universally available to patients, Qihan Biotech has raised two financing rounds. It has multiple products at different stages of development, including QN-019a, which had already received IND approval from China NMPA to treat CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Qihan's deep scientific experience and technology advancements have enabled the company to create cutting-edge cell therapy products. Qihan Biotech is headquartered in Hangzhou, China.
Porton Advanced Solutions is a subsidiary of the leading CDMO, Porton Pharma Solutions. Porton Advanced has headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, providing end-to-end CDMO solutions for ATMPs. We offer services from cell banking, process, and analytical method development, cGMP production to fill & finish, covering different stages of drug development from early research, IITs, Investigational New Drug (IND) applications, clinical trials, New Drug Applications (NDA), to commercialization.
Porton Advanced has developed specialized CRO and CDMO platforms focusing on plasmids, viral vectors (lentiviral vector, adenoviral vector, AAV,etc), cell therapy CMC services including CAR-T, TCR-T, CAR-NK, HSC, exosome, etc) and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector production lines, 12 GMP-compliant cell therapy production suites (including 2 suites for infectious donors), and a multitude of clean rooms. As of now, we have successfully supported our clients to secure 19 global IND approvals from NMPA, FDA, and Medsafe, with 7 ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has supported the successful transition of several overseas clinical-stage pipelines into China.
Porton Advanced is committed to a customer-centric approach, offering excellent global, end-to-end CDMO services to our clients, enabling effective drugs to benefit the public sooner.
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