By Fineline Cube 
China-based CR Boya Biological Pharmacy Co. Ltd. (SHE: 300294) has announced that it has received clinical trial approval from the National Medical Products Administration of China (NMPA) for its human immunoglobulin for subcutaneous injection. The product is intended for the treatment of primary immunoglobulin deficiency, including conditions such as X-linked hypoimmunoglobulinemia, common variable immunodeficiency diseases, and immunoglobulin G subtype deficiency diseases.
Product Background and Market Context
Currently, similar products such as Hizentra, Cuvitru, and Xembify are available in overseas markets, having first secured marketing approval in the US, Holland, and the US in 2010, 2016, and 2019, respectively. However, foreign subcutaneous injection human immunoglobulin blood products are barred from domestic market approval in China, and no domestic manufacturers have been authorized to produce them. This leaves a significant gap in the market, with no approved subcutaneous injection human immunoglobulin products currently available in the country.-Fineline Info & Tech