AstraZeneca PLC Sponsored ADR (AZN.US) KRAS G12D inhibitor approved for clinical trials in China.

On January 15th, the China National Medical Products Administration Center for Drug Evaluation (CDE) announced on its official website that Astrazeneca PLC Sponsored ADR (AZN.US) has been granted clinical trial implicit approval for a new Class 1 drug AZD0022. This drug is intended to treat advanced solid tumors carrying the KRAS G12D mutation. According to information on the Astrazeneca PLC Sponsored ADR's official website, this is a KRAS G12D inhibitor currently in Phase 1/2 clinical trials internationally. In November 2023, Astrazeneca PLC Sponsored ADR reached an authorization agreement with Yousen Health to obtain global exclusive authorization for the UA022 project, a small molecular candidate drug targeting the KRAS G12D mutation in preclinical stages at that time. This may be the same drug that has now received clinical approval as AZD0022. Screenshot source: CDE official website KRAS is a common driver gene that undergoes mutations, and KRAS G12D is a major mutation subtype in KRAS mutations, detected in about 34% of pancreatic ductal adenocarcinoma, 12% of colorectal cancer, 4% of non-small cell lung cancer, and other types of cancer. Patients with KRAS G12D mutation have a poor prognosis, and there is currently no approved targeted therapy available. AZD0022 is a small molecular KRAS G12D inhibitor. According to the ClinicalTrials website, Astrazeneca PLC Sponsored ADR initiated a Phase 1/2a study (ALAFOSS-01) in October 2024 to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AZD0022 as a single therapy or in combination with the anticancer drug United Therapeutics Corporation in adult patients with KRAS G12D-mutated tumors. This international multicenter study is planned to be conducted in countries such as China, the United States, Australia, and Canada, with a target of enrolling 430 participants with various types of tumors including advanced solid tumors, non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma, and is expected to be preliminarily completed by January 2028.