Qihan Biotech Announces NMPA Approval of Investigational New Drug (IND) Application for QN-019a, a Multi-locus Gene-Editing Cell Therapy Product to treat CD19-positive B-Cell Lymphoma

HANGZHOU, China–(BUSINESS WIRE)–Hangzhou Qihan Biotech Co., Ltd. (“Qihan” or “Qihan Biotech” or “the Company”), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, announced today that the National Medical Products Administration (NMPA) approved its clinical trial application for the product QN-019a. It is the first IND approved in China for a gene-edited iPSC-derived cell therapy product.

Qihan Biotech utilizes multiplexable genome editing technology to modify human Induced Pluripotent Stem Cells (iPSCs) and differentiate them into natural killer (NK) cell therapy product QN-019a, targeting CD19-positive B-cell lymphoma. The clinical indication for QN-019a is CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. According to the official website of the Center for Drug Evaluation, NMPA, the clinical trial application for QN-019a cell injection has received approval as of July 18, 2023.

“The approval of our application for the clinical trial is a result of our team’s collaborative efforts and also signifies Qihan entering a new phase in its evolution. The IND approval is the first step in a long drug development journey, and we will adhere to scientific rigor and fully use our genome editing technology and in-depth biological knowledge to continue our research,” said Dr. Luhan Yang, the founder and CEO of Qihan Biotech. “We look forward to developing Off-the-Shelf cell therapy products with long-term efficacy for patients and realizing the vision of Qihan.”

About Qihan Biotech

Qihan Biotech is a biotechnology company applying genome editing technology to develop novel cell therapies and organs for transplantation. The company’s mission is to use high-throughput, multiplexable genome editing combined with expertise in transplantation immunology to create immunologically privileged allogeneic cells and xenogeneic organs for use as therapies to treat cancer, organ failure, and other complex medical conditions. With a vision to create a world in which cell and organ therapies are universally available to patients, Qihan Biotech has raised two rounds of financing and has multiple products at different stages of development, including QN-019a. Qihan’s deep scientific experience and technology advancements have enabled the company to create cutting-edge cell therapy products. Qihan Biotech is headquartered in Hangzhou, China. For more information, please visit the company’s website at www.qihanbio.com.

Forward-looking Statements

This release contains statements including, but not limited to, Qihan’s research development and/or relevant programs, its past, ongoing, and planned research studies, and the potential of Qihan’s research candidate. These and any other statements in this release are based on Qihan management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such statements. These risks and uncertainties include, but are not limited to, the risk that Qihan’s research program may not warrant further development, the risk that results observed in prior studies of Qihan’s research candidates will not be observed in ongoing or future studies involving these candidates, the risk of a delay or difficulties in the developing or transforming of Qihan’s research candidates, the risk that Qihan may cease or delay the research development of any of its candidates for a variety of reasons. Qihan is providing the information in this release as of this date and does not undertake any obligation to update any statements contained in this release as a result of new information, future events, or otherwise. Information concerning therapies and related products contained herein is not intended as medical advice.

Contacts

Media:

Mollee Xu

Qihan Biotech Public Relations

Tel: +86 0571-83500380

Fax: +86 0571-83500370

[email protected]