iPSC-CAR-NK Cell Therapy Clinical Result Published in Cell, Marking a Global Breakthrough in Autoimmune Disease Treatment

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 the publication of groundbreaking clinical result in Cell. The study highlights the therapeutic success of Qihan’s off-the-shelf, dual-targeting iPSC-derived CAR-NK cell product, QN-139b, in treating refractory systemic sclerosis (SSc). Conducted in collaboration with Professor Huji Xu’s clinical team at Shanghai Changzheng Hospital, this work marks the first-ever application of iPSC-CAR-NK cells in treating autoimmune disease, representing Qihan’s global leading technology for the cell therapy field.

QN-139b is a universal, dual-targeting CAR-NK product that eliminates pathogenic B cells and plasma cells by targeting both CD19 and BCMA. The product was developed from Qihan’s high-throughput gene editing platform and incorporates advanced features for enhanced safety and persistence. These include edits to nine genes, non-cleaving editing tools to prevent chromosomal rearrangements, transgene insertion into genomic “safe harbor”, and production from sequenced monoclonal iPSC lines to minimize genomic toxicity. To further enhance product safety, QN-139b includes a tEGFR safety switch and an innovative CD16 knockout to reduce risk of disease flares in autoimmune patients. In addition, incorporating proprietary persistence-enhancing elements and a low-immunogenicity design strengthens its in vivo expansion and therapeutic durability.

In the reported study, a 36-year-old female patient with a nearly 20-year history of diffuse cutaneous systemic sclerosis (dcSSc) received four doses of QN-139b (6 × 10⁸ cells per dose) on days 0, 3, 7, and 10, starting August 4, 2024. After six months of follow-up, QN-139b demonstrated a strong safety profile and remarkable clinical efficacy:

• Significant reduction in autoantibodies and normalization of complement levels
• Dramatic improvement in modified Rodnan skin score (mRSS)
• Enhanced ACR-CRISS score
• Histological evidence of B cell clearance, fibrosis suppression, lymphocyte depletion in affected tissues, and skin microvascular remodeling

These findings collectively indicate that QN-139b successfully induced immune reset in this refractory SSc patient.

“We are proud to see a patient with nearly two decades of systemic sclerosis achieve such meaningful clinical improvement following QN-139b treatment,” said Dr. Luhan Yang, Founder and CEO of Qihan Biotech. “We are grateful for Professor Xu’s team collaboration and the patient’s trust. While our journey in iPSC-NK development has seen both success and failure, we have remained steadfast in our mission to develop safer, more effective therapies for patients. Our years of innovation in reducing allogeneic immune rejection now empower not only iPSC-NK but also iPSC-T and universal CAR-T platforms—offering renewed hope for patients with autoimmune diseases worldwide.”

Qihan Biotech continues to lead the next wave of cell therapy innovation, with its patient-centered approach and commitment to redefining immune reset therapies for chronic, refractory autoimmune diseases.

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, autoimmune diseases, 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 financing rounds. It has multiple products at different stages of development, including QN-019a, which had already received IND approval from China NMPA to treat CD19-positive relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. 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.

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