On January 15, AstraZeneca (AZN.US) received implied approval for clinical trials of its new Class 1 drug AZD0022, intended for the treatment of advanced solid tumors carrying the KRAS G12D mutation.
According to the latest announcement on January 15 from the official website of the Chinese National Medical Products Administration's Center for Drug Evaluation (CDE), AstraZeneca (AZN.US) has received implied approval for clinical trials of its new Class 1 drug AZD0022, intended for the treatment of advanced solid tumors carrying the KRAS G12D mutation. According to the pipeline information on AstraZeneca's official website, this is a KRAS G12D inhibitor currently in Phase 1/2 clinical trials globally.
In November 2023, AstraZeneca reached an authorized collaboration with Yousen Jianheng, obtaining global exclusive rights to the preclinical-stage small molecule candidate drug UA022 project targeting the KRAS G12D mutation, which may be the AZD0022 approved for clinical trials this time.
Screenshot source: CDE official website.
KRAS is a commonly mutated driver gene, and KRAS G12D is the main mutation subtype among KRAS mutations, detectable in approximately 34% of pancreatic ductal adenocarcinomas, 12% of colorectal cancers, and 4% of non-small cell lung cancers, as well as several other types of cancers. Patients with KRAS G12D mutations have poor prognoses, and currently, no related targeted therapies have been approved for marketing.
AZD0022 is a small molecule KRAS G12D inhibitor. According to the ClinicalTrials website, AstraZeneca launched a Phase 1/2a study (ALAFOSS-01) in October 2024, aimed at evaluating the safety, tolerability, pharmacokinetics, and efficacy of AZD0022 as a monotherapy or in combination with anticancer drugs for adults with KRAS G12D mutation tumors. This study is an international multicenter study intended to be conducted in countries such as China, the USA, Australia, and Canada, planning to recruit 430 participants, including those with advanced solid tumors, non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma, and other tumor types, with the goal of preliminary completion in January 2028.
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