China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has revealed that a market filing for its generic version of Japan-based Takeda’s (TYO: 4502) Livtencity (maribavir) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the potential introduction of a more accessible treatment option for cytomegalovirus (CMV) infections in China.
Indications and Approval Status of Maribavir
Maribavir is an anti-CMV antiviral drug used to treat CMV infection and/or disease in adult patients who have undergone hematopoietic stem cell transplantation or solid organ transplantation and are refractory to one or more previous treatments, such as ganciclovir, valganciclovir, cidofovir, or foscarnet. The drug has already received approval in the US, European Union, and Japan, and was granted NMPA approval in December 2023.
Regulatory Landscape for Generic Versions in China
Currently, no generic version of maribavir is approved in China. However, another copycat version manufactured by Aosaikang’s Nanjing unit is also awaiting regulatory decisions in the country. The acceptance of Aosaikang’s market filing for review highlights the potential for increased competition and availability of treatment options for patients with CMV infections.-Fineline Info & Tech
