HeLuo XinTu Completes World's First Clinical Infusion of Universal iPSC-Derived Platelets, Pioneering a Solution to Global Platelet Shortage

In the post-pandemic era, the global landscape of clinical blood usage has undergone profound changes. The demand for platelets, driven by complex medical scenarios such as cancer chemotherapy, emergency surgeries, thrombocytopenia, and aplastic anemia, continues to rise. At the same time, the acceleration of population aging and the shrinking of the eligible blood donor pool have created dual pressures, intensifying the supply-demand imbalance of clinical platelets. Industry data shows,China's annual shortage of single-donor platelets is expected to exceed 3 million units by 2030, with the corresponding derivative product market size surpassing 50 billion yuan.More critically, the current platelet collection model is constrained by the scarcity of donor resources and the limited storage duration of the products, making it difficult to meet the stepwise increase in regular clinical demands, let alone ensure rapid response for emergency blood transfusions during major public health events.

Renerval Therapeutics relies on the induced pluripotent stem cell (iPSC) directional differentiation technology platform,Breakthrough in overcoming the three core barriers of industrial-scale preparation of artificial platelets—mass production, maintaining high activity and stability, and dynamic all-round quality control, building the world's first"On-demand production, safe and accessible"Intelligent Platelet Biomanufacturing System.

The successful infusion of clinical-grade platelets marks Renerval Therapeutics' achievement in the field of cell therapy.Two Major Milestone Breakthroughs:

First,Bridging the industrialization gap of artificial regenerated platelets from laboratory processes to GMP-standard scaled production;

Second,For the first time in the history of biomedicine, the clinical feasibility of a universal artificial blood "on-demand precision blood supply" model has been verified, providing a disruptive solution for building an anti-cyclical and anti-emergency resilient blood security system.

Renerval Therapeutics was founded in 2021, asThe first innovative enterprise in China to achieve industrial-grade preparation of clinical-grade iPSC-derived blood cells without nuclei, always focusing on the field of cell therapy and regenerative medicine. In recent years, under the leadership of Dr. Wang Wenyuan, chairman and chief scientist, the research and development team has been committed to building a complete in vitro artificial blood system, covering the preparation and application research and development of platelets and other non-nucleated blood components. Through independent research and development and technology integration,Achieved breakthroughs in multiple core technologies, including key technologies such as the bottleneck of iPSC directional differentiation efficiency and the functional homeostasis maintenance of anucleate cells, and successfully advanced the first pipeline into the clinical stage.

"This technological breakthrough is not only the result of our ten years of perseverance, but also a mission driven by the significant medical needs of our country."Wang Wenyuan, founder of Renerval Therapeutics and researcher at the Center for Excellence in Molecular Cell Science, Chinese Academy of Sciences, stated,“Based on our self-developed modular biomanufacturing system, we will accelerate the industrialization process of artificial platelets, expedite the completion of large-scale production line construction and clinical entry, to provide global patients with efficient, safe, and readily accessible platelet products, striving to become a core driving force in the transformation of global transfusion medicine.