Porton Advanced’s End-to-End CDMO Service Drives Qihan Biotech’s First-in-Class Dual-targeting CAR-T IND Approval in China

November 21, 2025 – Qihan Biotech announced that China's National Medical Products Administration (NMPA) has cleared Qihan Biotech's Investigational New Drug (IND) application for its proprietary, first-in-class, dual-targeting CAR-T cell therapy, QT-019B for refractory systemic lupus erythematosus (rSLE).

According to Qihan Biotech, QT-019B is the first universal CAR-T cell product for autoimmune diseases to secure IND approvals from both the U.S. FDA and NMPA. As Qihan Biotech’s CDMO partner, Porton Advanced leveraged its CMC expertise to secure China-U.S. IND approvals while maintaining a flawless regulatory record.

Porton Advanced's 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.

So far, Porton Advanced has supported 12 IND approvals for CAR-T therapies across China and U.S. with 100% submission success, and has facilitated 21 global IND approvals across modalities including 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 in vivo CAR-T pipelines, further enhancing its position as a trusted CDMO in cell and gene therapies worldwide.

About QT-019B

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.

QT-019B’s dual CD19/BCMA targeting is designed to address a broad spectrum of antibody-mediated autoimmune disorders. Leveraging unmet clinical needs, robust IIT data and tailored regulatory pathways, Qihan Biotech will expand the indication into multiple sclerosis (MS), autoimmune hemolytic anemias (AIHA), idiopathic inflammatory myopathies (IIM) and beyond — delivering a truly universal therapy to patients 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, 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 21 global IND approvals from NMPA, FDA, and Medsafe, with 9 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.