China-based Luye Pharma Group (HKG: 2186) announced approval from the Hainan Medical Products Administration for lurbinectedin (LY01017), an RNA polymerase II inhibitor, to treat metastatic small-cell lung cancer (SCLC) in patients with disease progression after chemotherapy. The drug will be available through Hainan’s Boao Lecheng International Medical Tourism Pilot Zone, designated for urgent clinical needs.
Drug Profile
Developed by Spain’s Pharma Mar (MCE: PHM), lurbinectedin targets RNA polymerase II, an enzyme overactivated in transcriptionally addicted tumors. The drug promotes tumor cell death and normalizes the tumor microenvironment. Approved in the U.S. (June 2020) as Zepzelca, it also received temporary nods in Australia, UAE, Canada, and Singapore for recurrent SCLC. Clinical trials showed a 35% overall response rate (ORR) and 5.3-month median duration of response (DoR).
Regulatory Details
Luye licensed exclusive China rights from Pharma Mar in April 2019. A Hong Kong NDA filing was submitted in March 2024. The Hainan approval grants local access to lurbinectedin, aligning with the zone’s policy for overseas-approved drugs addressing critical needs.-Fineline Info & Tech
