AstraZeneca's KRAS G12D Inhibitor AZD0022 Receives IND Acceptance in China for Solid Tumors

Today (November 13), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China,AstraZeneca's Class 1 New Drug AZD0022 Clinical Trial Application Accepted. According to AstraZeneca's official pipeline information,This is a KRAS G12D inhibitor intended for the treatment of solid tumors.. The product is currently in Phase 1 clinical trials internationally.

Notably, AstraZeneca reached an agreement with Yoson Genehealth in November 2023.Authorized Cooperation, Obtain preclinical stage targetingKRAS G12DThe global exclusive license for the small molecule candidate drug UA022 project with mutations is speculated to be AZD0022, which is currently under clinical application.

Screenshot source:CDE Official Website

KRASIs a common driver gene mutation,KRAS G12DYesKRASThe predominant mutation subtype, found 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 currently, no targeted therapies have been approved for marketing.

AZD0022 is a small molecule KRAS G12D inhibitor that has just entered the clinical research stage in the fourth quarter of this year.According toClinicalTrialsAccording to the official website, AstraZeneca launched a Phase 1/2a study (ALAFOSS-01) in October this year 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 the United States, Australia, and Canada, with an enrollment target of 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.

This timeAZD0022's IND application in China suggests it may enter clinical trials in the country in the near future.

According to publicly available information, dozens of new drugs targeting KRAS G12D have entered clinical research stages worldwide, with the most advanced candidates already in Phase 2 clinical trials.These types of drugs under research cover small molecules, TCR-T cell therapies, siRNA drugs, and protein degradation therapies.Since this year, products targeting this site have also seen significant progress, such as:

• In July this year, the subsidiary journal of "Cell", "Cancer Cell" (Cancer Cell) Launched a specific inhibitor related to KRAS G12DHRS-4642A latest development in the research, the paper points out, is the first reported clinically effective KRAS G12D-specific inhibitor to date;

• In October this year, 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 technology can benefit patients as soon as possible.