PharmaCRO BoTeng Bio Congratulates Qihan Bio on FDA IND Approval of Second Allogeneic Dual-Target CAR-T Product QT-019C

Recently, Hangzhou Qihan Biotech Co., Ltd. announced that its independently developed universal, dual-target (CD19/BCMA) CAR-T cell product QT-019C has officially received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This marks another significant milestone for Porton Biologics Ltd. in empowering clients to advance in the field of universal cell therapy through high-quality CDMO services, following the successful dual filing in China and the United States for the first collaborative product, QT-019B.

Porton Biologics, as the core CDMO partner of Qihan Biotech, extends its warmest congratulations! Leveraging its extensive experience in plasmid project execution and CMC delivery, Porton Biologics has once again efficiently facilitated Qihan Biotech’s receipt of clinical trial authorization from the U.S. FDA, further strengthening the deep collaboration between the two parties in the field of universal CAR-T therapy.

One-Stop CDMO Service Platform Achieves New Milestones

As a customer-centric CDMO, Porton Biologics Ltd. boasts R&D and manufacturing facilities spanning over 20,000 square meters and has established a one-stop CRO and CDMO platform covering plasmids, viral vectors, cell therapy, gene therapy, and nucleic acid therapies, providing comprehensive service solutions across the entire product lifecycle from preclinical research to commercialization.

Porton Biologics boasts a robust plasmid platform process, with over 90% universality across different types of plasmids; its flexible process design can significantly enhance plasmid yield and reduce production costs. To date, Porton Biologics has cumulatively supported multiple innovative therapies in obtaining FDA approval for clinical trials, assisting clients globally in securing 26 clinical trial approvals. These cover various cutting-edge therapies including CAR-T, TIL, MSC, NK, mRNA, in vivo CAR-T, oncolytic viruses, and oncolytic bacteria, and several clinical sample production projects have been initiated.

About QT‑019C

QT-019C Cell Injection is the second “off-the-shelf” allogeneic CAR-T cell product developed by Hangzhou Qihan Biotech Co., Ltd. It uses leukapheresis products from healthy donors’ peripheral blood as the starting raw material. Through multiple gene-editing technologies, it stably expresses two chimeric antigen receptors targeting CD19 and BCMA respectively, enabling simultaneous recognition and elimination of cells expressing CD19 and BCMA.

To mitigate the risk of graft-versus-host disease (GVHD), this product features knockout of T-cell receptor (TCR) expression. Furthermore, multi-gene editing is employed to achieve low immunogenicity, thereby reducing allogeneic immune rejection. Its core advantage lies in minimizing or even eliminating the need for lymphodepleting chemotherapy preconditioning, aiming to provide patients with a safer and more convenient therapeutic option.

About Qihan Biotech

Qihan Biotech is a clinical-stage biotechnology company headquartered in Hangzhou, China, co-founded by Dr. Luhan Yang and Professor George Church. The company advances the clinical translation of universal cell therapies through multiplex gene editing, synthetic biology, and scalable GMP manufacturing systems. Qihan Biotech’s mission is to provide safe, effective, and immune-evasive universal cell therapy products, making innovative treatments accessible to patients worldwide.

About Porton Biologics

Porton Biologics Ltd., established in December 2018, leverages the support of a listed company—Porton Pharma Solutions Ltd.(Stock Code: 300363), providing global customers with one-stop service solutions for the full lifecycle of gene and cell therapy drugs, from preclinical research to market launch.

Porton Biologics has established CRO and CDMO platforms for plasmids, viral vectors, cell therapy, gene therapy, nucleic acid therapies, and live biotherapeutic products, with a total area exceeding 20,000 m²2a R&D and manufacturing base equipped with 10 viral vector production lines, 12 GMP cell therapy production lines (including two commercial-scale workshops), and over 100 cleanrooms. To date, Porton Biologics has supported 12 projects in Phase I/II clinical trials or undergoing commercial process changes, cumulatively helping clients secure 26 clinical trial approvals globally (covering China, the United States, New Zealand, and other countries), and successfully introducing multiple overseas projects into China.

We remain committed to a customer-centric approach, delivering global, end-to-end, and exceptional CDMO services to ensure that high-quality medicines reach the public sooner.

Porton Pharma Solutions Ltd. was established in 2005, providing end-to-end CDMO services covering the entire lifecycle from preclinical research to commercialization for global pharmaceutical companies, biotechnology firms, and research institutions. Its services encompass the full process from active pharmaceutical ingredients (APIs) to finished dosage forms for small molecule drugs, peptide and oligonucleotide therapeutics, protein and conjugate drugs, as well as cell and gene therapies. By the end of 2025, the company employed over 4,300 people worldwide, had served more than 1,400 clients, and successfully delivered over 5,000 projects. Adhering to a customer-centric approach, we are committed to delivering innovative and reliable global CDMO solutions, ensuring that high-quality medicines reach patients sooner.