China-based Luye Pharma Group (HKG: 2186) has announced that Hong Kong’s pharmacy and poisons board has approved a market approval filing for the company’s lurbinectedin (LY01017), a drug indicated for metastatic small-cell lung cancer (SCLC) in patients with tumor progression during or after platinum-based chemotherapy. The approval, facilitated by the Greater Bay Area (GBA) drug and device special green channel, positions the product for availability to patients in mainland China as well.
Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (BME: PHM), selectively inhibits oncogenic transcription, promoting tumor cell death and normalizing the tumor microenvironment. Luye acquired exclusive development and commercialization rights for lurbinectedin in China through a licensing deal with Pharma Mar in April 2019. Conditionally approved to treat SCLC in the US in 2020, the drug has received approvals in dozens of countries globally. It was recently approved for marketing in Macau and was awarded priority review status in mainland China in June this year.- Flcube.com
