Eli Lilly & Co. (NYSE: LLY) has secured special approval for its RET kinase inhibitor Retevmo (selpercatinib) in China’s Bo’Ao Lecheng Medical Tourism Pilot Zone. The drug will be available at the Boao Super Hospital to treat RET gene fusion-positive non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and thyroid cancer in adults and children aged 12 and older. This marks Lilly’s first oncology product in the Lecheng zone, which allows accelerated access to drugs addressing critical unmet needs before formal mainland China approval.
Drug Profile and Approval Context
Retevmo, approved in the U.S. in 2020 for RET mutation-driven NSCLC and MTC, received conditional approval based on the Phase I/II LIBRETTO-001 trial. The Lecheng approval expands access to the drug for patients with advanced or metastatic cancers, leveraging the zone’s fast-track regulatory framework.
Partnership with Innovent Biologics
In March, Lilly deepened its partnership with China-based Innovent Biologics (HKG: 1801), granting Innovent exclusive commercialization rights to Retevmo and Cyramza (ramucirumab) in mainland China. The collaboration aims to accelerate Retevmo’s rollout in China’s oncology market.-Fineline Info & Tech