Luye's SCLC therapy lurbinectedin under clinical trial review in China



China-based Luye Pharma Group (2186.HK) announced a clinical trial filing for LY01017 (lurbinectedin), an RNA polymerase II inhibitor licensed from Spain’s Pharma Mar SA. The filing has been accepted for review by China's Center for Drug Evaluation (CDE).

RNA polymerase II is an essential enzyme that facilitates the transcription process, and can be over-activated in tumors with transcriptional addiction. Lurbinectedin gained approval from the US FDA in June this year, and is marketed under the trade name Zepzelca for use in relapsed small-cell lung cancer (SCLC) that has progressed after platinum-based chemotherapy treatment. The drug also hit Australia and Singapore via the Special Access Scheme, and has obtained orphan drug designations (ODDs) for SCLC in the US, European Union (EU), Switzerland, and Australia.

Luye struck a licensing deal with Pharma Mar in April 2019, taking exclusive development and commercialization rights to lurbinectedin in China. The Chinese biopharma also has the right to request a full technology transfer in relation to the molecule during the agreement period.

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