China-based Luye Pharma Group (HKG: 2186) has announced that its market filing for lurbinectedin (LY01017) in metastatic small cell lung cancer (SCLC) has been accepted for review by China’s National Medical Products Administration (NMPA). The filing pertains to patients with tumor progression during or after platinum-based chemotherapy, and the RNA polymerase II inhibitor has previously obtained priority review status in China.
Lurbinectedin’s Mechanism and Global Approvals
Discovered and developed by Spain-based Pharma Mar, S.A. (BME: PHM), lurbinectedin selectively inhibits oncogenic transcription, promoting tumor cell death and normalizing the tumor microenvironment. Pharma Mar secured the first approval for lurbinectedin in the US in June 2020 under the trade name Zepzelca, along with temporary approvals in Australia, the United Arab Emirates, Canada, and Singapore for use in recurrent SCLC with disease progression during or after platinum-based chemotherapy. In clinical trials, the overall response rate (ORR) of patients treated with the drug reached as high as 35%, with a median duration of response (DoR) of 5.3 months.
Luye’s Licensing Deal and Regional Development Rights
Luye acquired exclusive development and commercialization rights to lurbinectedin for the territory of China via a licensing deal with Pharma Mar in April 2019. A new drug application (NDA) filing for the drug was made in March 2022 in Hong Kong, where a Named Patient Program (NPP) was initiated for the drug in January of this year. The drug was approved in Hainan in July last year for urgent clinical use, highlighting its potential impact on patient care in the region.-Fineline Info & Tech
