Qihan Bio's Multiplex Gene-Edited iPSC-Derived Cell Therapy QN-019a Granted IND Approval in China

On July 18, Hangzhou Qihan Biotech Co., Ltd. announced that the clinical trial application for its product QN-019a has received tacit approval from the National Medical Products Administration.This is the first gene-editing iPSC-derived cell therapy product approved in China.

Qihan Biotech utilizes multi-site gene editing technology to modify human-induced pluripotent stem cells (iPSC) and differentiate them into natural killer (NK) cell product QN-019a targeting CD19-positive B-cell tumors. Its clinical indication is CD19-positive relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

Dr. Luhan Yang, founder and CEO of Hangzhou Qihan Biotech Co., Ltd., stated: "The approval of this new drug clinical trial application is the result of years of joint efforts by the team, and it also marks that Qihan's pharmaceutical, non-clinical, and clinical development has entered a new phase. The IND approval is just the first step in the long journey of drug development. We will adhere to the principles of scientific rigor and diligence, fully leverage our gene-editing technology and deep biological expertise to continue researching and develop off-the-shelf cell therapy drugs that are effective for patients in the long term, fulfilling Qihan's vision."

About Qihan Biotech

Hangzhou Qihan Biotech Co., Ltd. was founded in Hangzhou, China in 2017. It is a biotechnology company that applies high-throughput gene editing technology to the fields of cell therapy and organ transplantation. Qihan Biotech aims to leverage its high-throughput gene editing technology and deep understanding of immune transplantation to develop immunologically compatible allogeneic cell therapies and xenotransplantation solutions, bringing hope to millions of patients and their families worldwide. Qihan Biotech has raised over 100 million US dollars in cumulative financing. Currently, the company’s allogeneic cell therapy products have entered investigator-initiated clinical trials, and one of the products has received tacit approval for clinical trials from the National Medical Products Administration. For more information about Qihan Biotech, please visit the company's official website at www.qihanbio.com.

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