On May 22, 2025，Allist Pharmaceuticals announced that its innovative drug Airuikai (Glecirasib Citrate Tablets), a KRAS-G12C inhibitor, has been officially approved for market launch by the National Medical Products Administration (NMPA). The approval allows Airuikai to be used for the treatment of adult patients withKRAS®®G12C-mutated advanced non-small cell lung cancer (NSCLC) who have previously received at least one line of systemic therapy. This marks another innovative lung cancer therapy approved for Allist Pharmaceuticals, offering a new treatment option for patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) and helping to reshape the treatment landscape for this hard-to-treat cancer subtype.
The approval is based on results from a pivotal Phase II single-arm study evaluating the safety, tolerability, and effectiveness of Glecirasib monotherapy in patients with advanced non-small cell lung cancer harboring KRASG12Cmutations who had either failed or were intolerant to standard treatments.
The results demonstrated that Goleresai is both effective and well-tolerated. As of September 28, 2024, a total of 119 NSCLC patients were included in the analysis. The confirmed objective response rate (cORR), as assessed by the Independent Review Committee (IRC), was 49.6% (40.2%-59.0%), with a disease control rate (DCR) of 86.3% (78.7%-92.0%). The median duration of response (DOR) was 14.5 months (9.6 months to not estimable), median progression-free survival (PFS) was 8.2 months (5.2–11.1), and median overall survival (OS) was 17.5 months (13.6 months to not estimable).
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
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Post time: May-27-2025