Good News! Hycells Supports Qihan Bio’s Universal CAR-T Therapy in Obtaining FDA Approval!
Release Date:
2025-08-21 15:36
On August 13, 2025, Qihan Bio, a biotechnology company dedicated to applying high-throughput gene-editing technologies to cell therapy and organ transplantation, announced that its Investigational New Drug application for QT-019B, the company’s first independently developed universal, dual-target CAR-T cell product, has received formal approval from the U.S. Food and Drug Administration (FDA). QT-019B is the first universal CAR-T cell product for the treatment of autoimmune diseases that has been independently developed by a Chinese company and granted FDA clinical trial approval in the United States.
Hycells is deeply honored to have provided the core raw material—apheresis-derived leukopak—for this approved CAR-T product, thereby helping to secure FDA approval for its clinical trials and vigorously supporting the global recognition of China’s domestically developed cell therapies. To date, Hycells has assisted numerous clients in obtaining IND approvals and has successfully delivered thousands of batches of sample cells, consistently meeting the stringent audit requirements of more than 30 leading global pharmaceutical companies and CROs with exceptional quality, thus fostering long-term strategic partnerships.
Safer and more efficient! Universal CAR-T
For autoimmune A Blessing for Patients
QT-019B cell injection is a “off-the-shelf” allogeneic CAR-T cell product developed by Qihan Bio. It is manufactured using leukapheresis products derived from the peripheral blood of healthy donors as the starting material, which are then subjected to gene editing to stably express chimeric antigen receptors (CARs) targeting CD19 and BCMA. As a result, QT-019B is capable of both recognizing and eliminating cells that express CD19 and BCMA. In addition, precise gene editing has been employed to reduce the risk of graft-versus-host disease (GvHD), minimize allogeneic immune rejection, and enhance safety. Qihan Bio plans to conduct clinical trials in the United States evaluating QT-019B for the treatment of refractory Systemic lupus erythematosus A Phase 1/2 clinical trial of (rSLE) is being conducted, with the University of Pennsylvania Hospital in the United States serving as the primary clinical research site.
“Qihuan Bio has designated the development of a universal cell therapy for autoimmune diseases as a strategic priority,” stated Dr. Yang Luhan, Founder and CEO of the company. “QT-019B is the company’s first self-developed, globally patented universal CAR-T cell product. To date, in investigator-initiated clinical studies conducted in China, this product has demonstrated robust clinical efficacy across a range of refractory autoimmune conditions, including refractory systemic lupus erythematosus. Taking into account multiple factors, the company has decided to prioritize the development of QT-019B for the indication of refractory systemic lupus erythematosus. Qihuan Bio is also honored to have established collaborative partnerships with the team led by Dr. Carl June at the University of Pennsylvania in the United States, as well as with its Department of Rheumatology and Immunology.”
She further stated, “Given the substantial unmet clinical needs among patients with refractory SLE, coupled with a relatively well-defined regulatory pathway for this indication and a high success rate in clinical trials, Qihuan Bio is highly confident in expediting the transition of QT-019B into the clinical development phase and in conducting pivotal registration studies within a short timeframe to secure marketing approval. To that end, the company has already established a clear global clinical development roadmap. Qihuan sincerely hopes that QT-019B, as a potentially disruptive innovative therapy, will fundamentally transform the current treatment landscape for refractory autoimmune diseases and provide safe, effective, and affordable therapeutic options for patients worldwide. In addition, the company is advancing several iterative innovation programs, including a specially designed allogeneic CAR-T cell product that does not require lymphodepleting preconditioning. The company anticipates that these products will progressively enter clinical trials, thereby reshaping the global treatment paradigm for patients with autoimmune diseases.”
Introduction to the Hycells Clinical Collection System
Hycells Biotechnology has meticulously developed a single-donor blood collection clinical system that far exceeds industry standards, providing innovative pharmaceutical companies with end-to-end, high-standard, seamlessly integrated solutions that span the entire value chain—from the “subject’s arm” to the “manufacturing floor.”
Hycells not only provides clients with fully compliant raw materials for single-donor blood collection, but has also innovatively launched a “Super Donor Screening Service” that employs a systematic approach to significantly enhance R&D efficiency and success rates. Currently, two flexible pathways are available. ：
1. Precision pre-screening of the cryopreserved PBMC library: Based on the customer’s specific cellular functional requirements, we rapidly identify and select eligible donor candidates from our large-scale cryopreserved PBMC library. Once the target donors are confirmed, we efficiently re-engage these “super donors” for apheresis collection, providing you with high-quality, highly active cell starting materials.
2. One-stop customized “from blood to screening”: Hycells directly recruits healthy donors, collects whole blood, and completes the isolation and cryopreservation of PBMCs, thereby obtaining cryopreserved cells. PBMC cells This is intended for small-scale pilot studies. To further mitigate clients’ R&D risks, Hycells Laboratory can also be engaged to conduct preliminary screening of cell functional assays, thereby identifying the optimal donor before proceeding to the precision apheresis stage.
Advantages of the Hycells Clinical Collection System
1. Standardized and Compliant Clinical Center Network
Rigorous Clinical Center Accreditation and Quality Management System: Both Hycells and its collaborating clinical centers are required to undergo comprehensive assessments and audits to ensure full compliance with GCP and the company’s stringent internal standards in terms of infrastructure, personnel qualifications, standard operating procedures (SOPs), and ethical guidelines.
Standardized workflows: From subject screening, informed consent, and sample-collection scheduling to the actual collection procedure, sample labeling, temporary storage, and transportation, each step is clearly defined to ensure operational consistency, data integrity, and traceability in multi-center clinical studies.
2. Precision Refine the data collection process
Personalized customization of parameters: rejecting a one-size-fits-all collection approach. Based on the specific type of cell therapy product, process requirements, and individual subject characteristics, the team proactively optimizes key parameters of the collection procedure to maximize the yield, viability, and functional purity of the target cells.
End-to-end cell-state management: from the selection of anticoagulants and precise flow-rate control to maintaining optimal temperature throughout the collection process, every detail that could exert stress on the cells is meticulously managed to ensure they are in peak condition from the moment they leave the body.
3. A specialized, traceable cold-chain logistics system
Specialized cold-chain solutions: fully validated, professional transport containers with real-time temperature monitoring. Any deviation from the preset temperature range triggers an alarm, which is promptly addressed by dedicated personnel, ensuring that samples are always maintained in a perfectly stable environment.
End-to-end digital chain management: each transfer package is uniquely identified,
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This article will examine how He Yousheng proactively integrates the quality management system into the hospital setting, translating compliance requirements into concrete, actionable practices starting at the sample collection stage, thereby establishing a trust‑based chain that can withstand audit scrutiny.
In selecting hPL raw materials, Heyousheng consistently upholds the principle that “safety is determined at the source.” The samples used in production are rigorously collected in accordance with applicable standards and undergo stringent donor screening, effectively mitigating the risk of disease transmission at the very outset. Moreover, from informed consent forms and ethical approvals to clinical‑grade collection under the GCP framework, Heyousheng has established a fully traceable documentation chain, ensuring that every sample is accounted for and verifiable. In contrast to the industry’s longstanding reliance on the conventional model of using expired blood supplies from blood banks, this approach represents a structural, generational upgrade.
Recently, the research team led by Researcher Bian Yingjie at the Guangzhou National Laboratory, in collaboration with partners from Sun Yat-sen University, published a study titled “Iron overload in the tumor microenvironment induces CD8⁺ T cell ferroptosis and dysfunction” in the internationally renowned academic journal Nature Communications.
Hycells Recruitment | Never Stop Exploring, Never Stop Innovating
The company consistently upholds its core values of “people‑centricity, quality first, and innovation as the foundation,” remains driven by technological innovation, and sets new industry benchmarks for domestic innovation, thereby laying a solid foundation for the development and global advancement of China’s innovative pharmaceutical sector.
The HiXpan® NK Serum-Free Culture Kit, Version 3.0, is manufactured in strict compliance with GMP standards, and its production system fully adheres to relevant guidelines and regulations, including the “818 Requirements,” positioning it for pharmaceutical‑grade manufacturing and applications.
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