Biotec Pharmacon Congratulates Qihan Bio on CDE's Implicit Approval of China's First Universal Dual-Target CAR-T Therapy QT-019B for Clinical Trials

November 21, 2025Qihan Biotech Announces IND Approval for QT-019B, Its First Universal, Dual-Target (CD19/BCMA) CAR-T Cell Product with Global Rights, with its first indication being refractory systemic lupus erythematosus (rSLE).

According to Qihan Biotech, QT-019B is the first universal dual-target CAR-T cell product independently developed by a Chinese company to have consecutively received implied approval from the U.S. FDA and China's CDE.Porton Biologics, as the CDMO partner of Hangzhou Qihan Biotech, extends its heartfelt congratulations! With extensive experience in project execution and CMC delivery, Porton Biologics rapidly facilitated the acquisition of IND approvals in both China and the United States for this project.

To date, Porton Biologics has cumulatively supported six innovative therapies in obtaining FDA clinical trial approval and assisted clients globally in securing 21 clinical approvals, covering a variety of innovative therapy products such as CAR-T, TIL, MSC, NK, mRNA, oncolytic viruses, and oncolytic bacteria. Porton Biologics continues to upgrade its CDMO one-stop platform. In the ex vivo CAR-T field, it has successfully helped CAR-T products obtain 12 IND approvals in both China and the U.S. without any supplementary filings, while launching multiple clinical sample production projects. At the same time, it is helping several global clients advance the research, development, and implementation of in vivo CAR-T pipelines in China.

About QT-019B

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 T-cell receptors (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.

QT-019B Targets Both CD19 and BCMA, Holds Promise for Meeting Medical Needs of Different Types of Autoimmune Diseases, Potentially Applicable to Various Antibody-Related Conditions. Hangzhou Qihan Biotech Co., Ltd. will develop indications including Multiple Sclerosis (MS), Autoimmune Hemolytic Anemia (AIHA), and Idiopathic Inflammatory Myopathies (IIM), among others, based on unmet clinical needs of patients with autoimmune diseases, Investigator-Initiated Trial (IIT) data, and consideration of registration pathways for different indications, aiming to fulfill broader medical needs of patients.

About Qihan Biotech

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

About Porton Biologics Ltd.

Porton Biologics Ltd. was established in December 2018, based in Suzhou, relying on the listed company-Porton Co., Ltd. (stock code: 300363), providing global customers with one-stop service solutions for gene and cell therapy drugs from preclinical research to the entire life cycle of drug marketing.

Porton Biologics Ltd. has established CRO and CDMO platforms for plasmids, viral vectors, cell therapy, gene therapy, and nucleic acid therapies. It owns R&D and production bases with a total area of over 20,000 square meters, 10 viral vector production lines, 12 GMP cell therapy production lines (including two positive production workshops), and hundreds of cleanrooms. As of November 2025, Porton Biologics has helped clients obtain 21 clinical trial approvals globally, covering countries such as China, the United States, and New Zealand. It has nine Phase I/II clinical cell therapy projects and has successfully assisted multiple overseas projects in transferring to China.

We are committed to being customer-centric and providing customers with excellent global, end-to-end CDMO services, enabling life-saving drugs to benefit the public sooner.