RE: Savolitinib approval14 Jan 2025 10:30
Yes, good news.
Cavendish company flash
HUTCHMED has announced that that the Chinese drug regulator (NMPA) has granted full approval for Orpathys (savolitinib), expanding its indication to both first-line (treatment-naïve) and previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring the MET exon-14 skipping (METex14) genetic alteration. This follows the conditional approval granted in 2021, which allowed Orpathys to be used in previously treated METex14 NSCLC patients. The transition to full approval, alongside the expanded indication, is based on data from a Chinese Phase III clinical trial in which Orpathys demonstrated encouraging efficacy and safety in both patient groups. Orpathys generated c$46.1m in inmarket sales in China in 2023 (c$29m attributable to HCM). With HCM’s partner AstraZeneca providing robust commercial infrastructure in China, we anticipate that the expanded label indication into first-line use will further increase market share and drive future Orpathys revenue growth.