Qihan Bio Announces First Clinical-Grade Xenotransplantation Prototype 'Pig 3.0' in Nature Biomedical Engineering

Hangzhou Qihan Biotech Co., Ltd. is a biotechnology company dedicated to developing cell and organ products using multi-gene targeting technology. Today, Qihan Biotech announced that its scientists have successfully created the first-generation prototype for clinical xenotransplantation, dubbed “Pig 3.0.” This achievement was published in Nature Biomedical Engineering, a subsidiary journal of Nature. The study demonstrates that the organs developed by Qihan Biotech exhibit improved immunocompatibility with humans and have completely eliminated porcine endogenous retroviruses (PERV).

Today, organ shortage is a significant global issue. The birth of “Pig 3.0” marks an important step forward in the safety and efficacy of xenotransplantation. Meanwhile, this achievement demonstrates that Hangzhou Qihan Biotech Co., Ltd. has leveraged its high-throughput gene-editing technology platform to endow cells with new functionalities, showing considerable potential for applications in tumor immunocyte therapy and regenerative medicine.

Qihan Biotech’s primary research focuses on two pipelines: immunocompatible human allogeneic cell therapies and xenotransplantation therapies. Currently, cell therapy remains a novel treatment modality, with clinical applications constrained by immune compatibility issues. Moreover, xenotransplantation carries the risk of endogenous retrovirus infection. The research findings published today by Qihan Biotech hold significant importance for overcoming these two major limitations.

In this study, scientists at Qihan Biotech combined CRISPR-Cas9 and transposon technologies to breed a special pig with 13 independent genetic modifications. Qihan Biotech addressed the immunological and coagulation incompatibilities between pigs and humans and eradicated porcine endogenous retroviruses (PERVs). Meanwhile, these genetically engineered pigs and their organs exhibited normal physiological characteristics, fertility, and the ability to transmit transgenes to the next generation.

Dr. Luhan Yang, Co-founder and CEO of Qihan Biotech, stated, “This is Qihan’s first clinical-grade prototype for xenotransplantation featuring dual functionalities. This achievement is highly encouraging, and we are currently evaluating the efficacy and safety of the engineered organs in non-human primates.”

James F. Markmann, Director of the Transplantation Center at Massachusetts General Hospital, also stated, “This study marks a milestone for Qihan Biotech in bringing hope to millions of patients awaiting organ transplantation.”

Dr. George Church, Professor of Genetics at Harvard Medical School, Co-founder of Qihan Biotech, and Co-Chair of its Scientific Advisory Board, expressed strong confidence in the company’s development. He stated, “The global demand for organ transplants far exceeds the number of available donors. If this technology is validated in subsequent research, it will significantly alleviate the severe shortage of organs worldwide. Leveraging its achievements, Qihan Biotech holds promise for developing novel immunocompatible cell and organ products, demonstrating the promising prospects of multi-gene targeting technology.”

Hangzhou Qihan Biotech Co., Ltd. was established in Hangzhou, China, in 2017. As a biotechnology company dedicated to developing cell and organ products using multi-gene targeting technology, Qihan Biotech aims to leverage its high-throughput gene editing platform and profound understanding of immunotransplantation to develop immune-compatible allogeneic cell therapies and xenogeneic organ therapies, bringing hope to millions of patients and their families worldwide.

Following its Series A+ financing, Hangzhou Qihan Biotech Co., Ltd. is currently in the IND preparation stage for allogeneic cell therapy.

As a pioneer in novel gene-editing technologies, Qihan Biotech has established a high-throughput gene-editing platform leveraging CRISPR-Cas9 and transposon technologies. The company has achieved the world’s most complex and highest-throughput gene knockouts and insertions, demonstrating their functionality in vivo.

Qihan Biotech’s research team is committed to in-depth exploration of genetic immunology, leveraging specialized expertise and technologies to develop immunocompatible cells and organs that evade host immune attacks. Currently, the company primarily uses pigs as donors for xenotransplantation research. Meanwhile, Qihan Biotech aims to engineer allogeneic immune cells for cancer therapy and develop other functional cell types to commercialize regenerative medicine applications.