AstraZeneca's (AZN.US) KRAS G12D inhibitor has been approved for clinical trials in China.

On January 15, the latest public information on the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed that AZD0022, a new drug of AstraZeneca (AZN.US), was granted a clinical trial implicit approval, which is intended to develop for the treatment of advanced solid tumors carrying KRAS G12D mutation. According to the pipeline information on AstraZeneca's official website, it is a KRAS G12D inhibitor, which is currently in the 1/2 phase clinical trial stage in the international range. AstraZeneca reached an exclusive license agreement with Yousen Healthcare in November 2023 for the targeted KRAS G12D mutation small molecule candidate drug UA022 project, which may be the same as the clinical approval AZD0022. The screenshot source: CDE's website KRAS is a frequently mutated driver gene, and KRAS G12D is the major mutation subtype of KRAS mutations, which can be detected in approximately 34% of pancreatic ductal adenocarcinoma, 12% of colorectal cancer, and 4% of non-small cell lung cancer and other types of cancer. Patients with KRAS G12D mutations have poor prognosis and currently no related targeted therapies have been approved for marketing. AZD0022 is a small molecule KRAS G12D inhibitor. According to ClinicalTrials.gov, AstraZeneca started a 1/2a phase study (ALAFOSS-01) in October 2024 to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AZD0022 as a single agent or in combination with anticancer drugs in adult patients with KRAS G12D mutations. This is an international multicenter study, which is planned to be conducted in China, the United States, Australia, Canada and other countries, and plans to enroll 430 participants, including advanced solid tumors, non-small cell lung cancer, colorectal cancer, pancreatic ductal cancer and other tumor types, and is expected to be completed preliminarily in January 2028.