Luye Pharma (02186.HK) announced that its innovative drug Zejula (Niraparib for Injection) has been included in the priority review and approval process and has obtained marketing approval from the China National Medical Products Administration, applicable to adult patients with metastatic small cell lung cancer (SCLC) with disease progression during or after platinum-containing chemotherapy.
As of now, Zejula has obtained marketing approvals in a total of 17 countries or regions worldwide. The group has been authorized to develop and commercialize the product in mainland China, Hong Kong, and Macau, and has successfully promoted its marketing approval in these three regions.