China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Zepzelca (lurbinectedin) with priority review status. This approval allows the use of Zepzelca to treat adult patients with metastatic small cell lung cancer (SCLC) who are undergoing platinum-based chemotherapy or have experienced disease progression after chemotherapy.
Lurbinectedin: A Selective Inhibitor of Oncogenic Transcription
Discovered and developed by Spain-based Pharma Mar, S.A. (MCE: PHM), lurbinectedin is a drug that selectively inhibits oncogenic transcription, promoting tumor cell death and normalizing the tumor microenvironment. This mechanism of action offers a new approach to treating SCLC, a particularly aggressive form of lung cancer.
Luye Pharma’s Licensing Deal and Global Expansion
Luye acquired exclusive development and commercialization rights to lurbinectedin for the territory of China through a licensing deal with Pharma Mar in April 2019. This strategic move has positioned Luye to bring this innovative treatment to Chinese patients. The drug received conditional approval to treat SCLC in the US in 2020 and has since been approved in dozens of countries worldwide.
Recent Approvals in Hong Kong, Macau, and China
Zepzelca was approved for marketing in Hong Kong and Macau to treat metastatic SCLC in patients with tumor progression during or after platinum-based chemotherapy in November and December of last year, respectively. The drug was awarded priority review status in China mainland in June of the same year, highlighting its potential impact on the treatment landscape for SCLC in the region.-Fineline Info & Tech
