bonuswin|加科思-B：KRAS G12C抑制剂Glecirasib新药上市申请（NDA）

Garkos-B (01167) issued an announcement that the company developed on its own.BonuswinThe new drug marketing application (NDA) of KRAS G12C inhibitor Glecirasib (JAB-21822) has been formally submitted to the Drug Evaluation Center (CDE) of China's State Drug Administration (NMPA) for the treatment of second-line and above patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutation.

The NDA submitted this time is based on the results of a Phase II registered clinical study (NCT05276726) conducted in China. The purpose of this study was to evaluate the efficacy and safety of Glecirasib monotherapy in patients with non-small cell lung cancer with KRAS G12C mutation. The registered clinical results have been officially announced in the American Society of Clinical Oncology (ASCO) Series (ASCO Plenary Series) in April 2024 and at the American Society of Clinical Oncology Annual meeting Education Special session (Education Session) in June 2024. Data from the phase II registered clinical trial of Glecirasib published by ASCO Plenary Series in April 2024 showed that the confirmed objective remission rate (cORR) was 47% in patients with second-line non-small cell lung cancer.Bonuswin.9% (56amp 117), including 4 patients achieving complete remission (CR), 36 patients with tumor reduction of more than 50%, and a disease control rate (DCR) of 86.3%. The median progression-free survival (mPFS) was 8.2 months, and the median total survival (mOS) was 13.6 months. The median duration of remission (mDoR) data is not yet mature, with a 6-month and 12-month DoR ratio of 73.6 and 56.6 per cent, respectively.

In December 2022, based on its good efficacy and safety characteristics, Glecirasib was awarded by the Drug Evaluation Center of the State Drug Administration as a breakthrough drug for second-line and above treatment of patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutation.