IND Application of  NX01 was Approved

Zhuangya Biotechnology Co.,LTD (Neoletix) announced that NX01, Recombinant Human Coagulation Factor VIII for Injection, the first biologics based on Neoletix's proprietary protein expression technology platform, has been cleared on its Investigational New Drug (IND) application by NMPA for its clinical phase studies.

Recombinant factor FVIII is the first choice for the hemophilia A therapy and highly safe compared with plasma derived FVIII. However, due to the large size of the protein and its complicated manufacturing process, the expression level of recombinant factor FVIII is quite low, resulting in higher price for hemophilia A treatment, especially for low-and middle-income patients. Neoletix has developed a novel manufacturing process for recombinant FVIII covered by patents that are granted in both US and China, as well as PCT applications. The recombinant FVIII expression level has been increased more than 20 times or more, as compared tothe current international production levels. As the cost of this molecule can be dramatically reduced, we believe that we can have a major impact on landscape of hemophilia A prophylaxis and on-demand therapy once the product is on the market.

NX01 is a B-domain deleted human recombinant coagulation factor VIII and the clearance of our first IND marks an important milestone for Neoletix.