AstraZeneca's KRAS G12D Inhibitor AZD0022 Granted Clinical Trial Approval in China for Advanced Solid Tumors
AstraZeneca
Biopharmaceutical Manufacturer
On January 15, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced,AstraZeneca's New Drug Class 1 AZD0022 Receives Implied Clinical Trial Approval for Proposed Development in TreatmentCarryKRAS G12DAdvanced Solid Tumors with Mutations. According to the pipeline information on AstraZeneca's official website,This is a KRAS G12D inhibitor,Currently, within the international scope,1/2Phase of clinical trial.
AstraZeneca reached an agreement with Yosen Jianheng in November 2023Authorization Cooperation, obtained the targeted therapy in the preclinical stage at that timeKRAS G12DThe global exclusive license for the small molecule candidate drug UA022 project, which may be the AZD0022 recently approved for clinical trials.
Screenshot source:CDE Official Website
KRASIs a common driver gene mutation,KRAS G12DYesKRASThe primary mutation subtype in mutations, occurring in approximately 34% ofPancreatic Ductal Adenocarcinoma, 12% of colorectal cancers, 4% of non-small cell lung cancers, and various other types of cancer can be detected.KRAS G12DPatients with mutations have a poor prognosis, and there are currently no targeted therapies approved for marketing.
AZD0022 is a small molecule KRAS G12D inhibitor.According toClinicalTrialsAccording to the official website, AstraZeneca launched a Phase 1/2a study (ALAFOSS-01) in October 2024 to evaluate AZD0022.As a single therapy or in combination with anticancer drugsKRAS G12DMutated Adult Tumor PatientsSafety, tolerability, pharmacokinetics, and efficacy.This study is an international multicenter research planned to be conducted in countries such as China, the United States, Australia, and Canada, with an aim to enroll 430 participants.Including tumor types such as advanced solid tumors, non-small cell lung cancer, colorectal cancer, and pancreatic ductal carcinoma., scheduled for initial completion in January 2028.
According to public channel inquiries, dozens of new drugs targeting KRAS G12D have entered clinical research stages globally, with the more advanced products already in Phase 2 clinical trials.These types of drugs under research cover small molecules, TCR-T cell therapy, siRNA drugs, protein degradation therapy, etc.In clinical research, products targeting this site have also seen significant progress, such as:In July 2024, a subsidiary of "Cell"Cancer CellLaunched a Specific Inhibitor for KRAS G12DHRS-4642A latest development in the development;In October 2024, Revolution Medicines announced its KRAS G12D-targeted covalent inhibitorRMC-9805Preliminary positive data in treated pancreatic ductal adenocarcinoma (PDAC) patients receiving RMC-9805The disease control rate for PDAC patients is as high as 80%.。
We look forward to more products achieving breakthroughs in clinical applications, so that cutting-edge technologies can benefit patients as soon as possible.
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