China-based Luye Pharma Group (HKG: 2186) has announced the launch of a Named Patient Program (NPP) in Hong Kong, enabling access to lurbinectedin (LY01017), an RNA polymerase II inhibitor used to treat patients with relapsed small-cell lung cancer (SCLC). The program will provide immediate access to the drug for SCLC patients who have no other treatment options, with availability in all hospitals across the city. To facilitate the program, Luye has granted exclusive distribution rights to Abacus Medicine Pharma Services (AMPS) for the territory of Hong Kong.
Mechanism and Clinical Profile
RNA polymerase II is an essential enzyme that facilitates the transcription process and can be over-activated in tumors with transcriptional addiction. Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (BME: PHM), selectively inhibits oncogenic transcription, thereby promoting tumor cell death and normalizing the tumor microenvironment. The drug received its first approval in the US in June 2020 under the trade name Zepzelca and has since secured 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. Clinical studies have shown that lurbinectedin can achieve a 35% overall response rate (ORR) and a 5.3-month median duration of response (DoR).
Licensing and Development
Luye Pharma Group acquired exclusive development and commercialization rights to lurbinectedin for the territory of China through a licensing deal with Pharma Mar in April 2019. A new drug application (NDA) for the drug was filed in Hong Kong in March 2022. Additionally, Luye launched a patient access program in Hainan’s Lecheng Bo’ao International Medical Tourism Pilot Zone in July 2022, further expanding access to this innovative therapy.
Future Outlook
The launch of the Named Patient Program for lurbinectedin in Hong Kong marks a significant step in providing treatment options for patients with relapsed SCLC. With its proven efficacy and safety profile, lurbinectedin has the potential to improve outcomes for patients with limited therapeutic options. Luye’s strategic initiatives underscore its commitment to advancing oncology treatments and enhancing patient access to innovative therapies.-Fineline Info & Tech
