By Fineline Cube 
China-based Suzhou Xueji Biotechnology Co., Ltd (HemaCell), a pioneer in platelet regeneration-focused cell therapy, announced that its XJ-MK-002 has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of giant platelet syndrome (BSS). This marks another significant milestone for the company, which has already secured two Rare Pediatric Disease Designations (RPDDs) and two ODDs in the US.
Company Overview
HemaCell, recognized as the world’s third and China’s first cell therapy developer focused on platelet regeneration, is dedicated to advancing innovative solutions for blood disorders. The company’s lead product, XJ-MK-002, utilizes in vitro induction of stem cells to produce platelets without gene editing, ensuring high safety and maturity.
Product Innovation
XJ-MK-002 represents a novel approach to treating BSS, a rare genetic disorder characterized by abnormally large platelets. The therapy leverages HemaCell’s proprietary technology to generate platelets that are safe for transfusion across all age groups, including children, with no risk of tumorigenesis.
Market Potential
The FDA’s recognition underscores the potential of XJ-MK-002 to address significant unmet medical needs in the treatment of BSS. HemaCell is poised to further expand its global presence through strategic partnerships and clinical advancements.-Fineline Info & Tech