Yongsheng Biotech-KY applies for Taiwan drug license for cord blood cell preparation REGENECYTE®

Yongsheng Biotechnology-KY (4178) announced today (30th) that it has officially applied to the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare for the inspection and registration of the cord blood cell preparation REGENECYTE® Taiwan regenerative medical preparations to expand the clinical application of Yongsheng's cord blood cell preparations that meet international standards.

Yongsheng's umbilical cord blood cell preparation REGENECYTE® has been approved by the U.S. FDA for biologics and is approved for use in approximately 80 hematopoietic and immune system diseases. Zhang Shuoxiu, Vice President of Yongsheng, said that REGENECYTE® is an allogeneic umbilical cord blood hematopoietic precursor cell preparation. It is suitable for hematopoietic precursor cell transplantation from unrelated donors. With appropriate pretreatment, it can be used to rebuild the patient's hematopoietic system and immune system, and treat hereditary and acquired diseases that affect the hematopoietic system or related diseases caused by bone marrow suppressive therapy.

In the past, the clinical application scope of Taiwan's umbilical cord blood was limited to the 29 previously announced diseases. However, the application scope of REGENECYTE® approved by the US FDA BLA is broader than Taiwan's existing disease enumeration framework. It is expected to expand the clinical use of Taiwan's umbilical cord blood.

Zhang Shuoxiu pointed out that Yongsheng has more than 36,000 units of its own publicly donated umbilical cord blood bank resources, has successfully used more than 2,300 doses in clinical transplantation, and has been adopted by more than 350 medical centers around the world. It has dual international quality certifications from AABB and FACT.