Newsletter summary
Jakoz-B (01167) submitted an application for listing of a new KRASG12C inhibitor Glecirasib to NMPA in China.CapcomarcadeFor the treatment of KRASG12C mutationsCapcomarcadePatients with advanced or metastatic non-small cell lung cancer. The drug was identified as a breakthrough treatment, and clinical trials showed a high remission rate and disease control rate.
Text of news flash
[the new drug marketing application (NDA) of Glecirasib (JAB-21822), a KRASG12C inhibitor independently developed by Jiakos-B (01167), was formally submitted to the Drug Evaluation Center (CDE) of the State Drug Administration (NMPA) of China]
Recently, Gacos-B (01167) announced that its KRASG12C inhibitor Glecirasib (JAB-21822) new drug marketing application (NDA) has been formally submitted to the Drug Evaluation Center (CDE) of the State Drug Administration (NMPA) of China. This application indicates that the second-line and above treatment of advanced or metastatic non-small cell lung cancer patients with KRASG12C mutation will usher in a new treatment option.
It is reported that the submission of the NDA is based on the positive 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 KRASG12C mutated non-small cell lung cancer. The results of the relevant clinical studies are scheduled to be announced at the American Society of Clinical Oncology (ASCO) full Series (ASCOPlenarySeries) in April 2024 and the ASCO Annual meeting Education Special session (EducationSession) in June. According to the data released by ASCOPlenarySeries in April 2024, the confirmed objective remission rate (cORR) of Glecirasib in patients with second-line non-small cell lung cancer reached 47%.Capcomarcade.9% (56mp 117), with a median progression-free survival (mPFS) of 8.CapcomarcadeThe median overall survival time (mOS) was 13.6 months.
It is worth noting that, based on its remarkable efficacy and good safety, Glecirasib was awarded a breakthrough therapeutic drug certification by the Drug Review Center of the State Drug Administration in December 2022. In addition, a number of monotherapy and combination studies of Glecirasib are in full swing around the world, including combination with SHP2 inhibitor JAB-3312 in the treatment of non-small cell lung cancer, combination with cetuximab in the treatment of colorectal cancer, and registered clinical studies of monotherapy.