HeLuoXinTu Completes World’s First Clinical Infusion of Universal iPSC-Derived Platelets

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 pool of eligible blood donors create dual pressures, intensifying the supply-demand imbalance of clinical platelets. Industry data shows,China's annual shortage of apheresis 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 shelf life of the products, making it difficult to meet the stepwise increase in routine 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) directed differentiation technology platform,Breakthrough in overcoming the three core barriers of industrial preparation of artificial platelets—large-scale mass production, maintaining high activity and stability, and dynamic comprehensive quality control, building the world's first"Produced on Demand, Safe and Accessible"Intelligent Platelet Biomanufacturing System.

This successful infusion of clinical-grade platelets,Marks Renerval Therapeutics' Achievement in Cell Therapy FieldTwo Major Milestone Breakthroughs:

First,Bridging the industrial transformation gap from laboratory processes to GMP-standard scaled production of artificially regenerated platelets;

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 validated, providing a disruptive solution for building an anti-cyclical and anti-emergency resilient blood security system.

Renerval Therapeutics, established in 2021, has always focused on the fields 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 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 directed 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 our mission-driven commitment to addressing China's critical medical needs."Wang Wenyuan, founder of Renerval Therapeutics and researcher at the Center for Excellence in Molecular Cell Science, Chinese Academy of Sciences, Shanghai, stated,“Based on our independently developed modular biomanufacturing system, we will accelerate the industrialization process of artificial platelets, expedite the completion of large-scale production line construction and clinical access, 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.