Porton Advanced Powers Qihan Biotech’s Second FDA IND Approval for Allogeneic Dual-Targeting CAR-T Product

Recently, Qihan Biotech announced that its off-the-shelf, dual-targeting (CD19/BCMA) CAR-T cell therapy, QT-019C, has received IND clearance from the U.S. Food and Drug Administration (FDA). This milestone follows the successful China-U.S. filings for their first partnered product, QT-019B, and once again highlights the role of Porton Advanced's CDMO services in advancing Qihan’s universal cell therapy pipeline.

Leveraging its extensive experience in plasmid manufacturing and CMC delivery, Porton Advanced once again rapidly and efficiently supported Qihan Biotech in securing FDA IND clearance, further strengthening the partnership between the two companies.

End-to-End CDMO Platform

Porton Advanced operates over 20,000 square meters of R&D and GMP manufacturing facilities, offering an integrated CRO and CDMO platform covering plasmids, viral vectors, cell therapy, gene therapy, and nucleic acid therapeutics. We support clients across the full product lifecycle, from preclinical development through to commercialization.

To date, Porton Advanced has facilitated 26 global IND approvals across modalities including CAR-T, TIL, MSC, NK, in vivo CAR-T, mRNA, oncolytic virus, and oncolytic bacteria. Porton Advanced continues to demonstrate CDMO leadership by advancing multiple clinical supplies production projects and supporting global partners in developing next-generation cell and gene therapy pipelines, further enhancing its position as a trusted CDMO in cell and gene therapies worldwide.

About Qihan Biotech

Qihan Biotech is a clinical-stage company headquartered in Hangzhou, China. Co-founded by Dr. Luhan Yang and Professor George Church, it combines multiplex gene editing, synthetic biology and scalable GMP manufacturing to turn off-the-shelf cell therapies into reality. Our mission: safe, effective, immune-silent universal cell therapies that patients everywhere can access.

About Porton Advanced

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, Investigator-initiated Clinical Trial Services (IITs), and Investigational New Drug (IND) applications to clinical trials, New Drug Applications (NDA), and 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., bacterial vector and nucleic acid therapies. Our state-of-the-art, GMP-compliant facilities span an impressive 215,000 sq ft, equipped with 10 viral vector GMP-compliant production lines, 12 cell therapy GMP-compliant production suites (2 for commercial products) and a multitude of cleanrooms. As of now, we have successfully supported our clients to secure 26 global IND approvals from NMPA, FDA, and Medsafe, with 12 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 earlier access to good medicines.