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Article source: Medical Rubik's Cube Info
Author: Shi Bei
On November 1, the CDE official website showed that the clinical application of Mirati/Zai Lab's highly selective and potent oral KRAS G12C small molecule inhibitor MRTX849 tablets (adagrasib) was officially accepted by the State Food and Drug Administration
.
Adagrasib was developed by Mirati.
On June 1 this year, Zai Lab reached a cooperation with Mirati to obtain the right to develop and exclusively commercialize adagrasib in Mainland China, Hong Kong, Macau and Taiwan
.
Mirati will receive an upfront payment of US$65 million, as well as potential milestone payments and royalties of up to approximately US$273 million
The KRAS G12C protein regenerates every 24-48 hours, and adagrasib is optimized to have a long half-life and a wide tissue distribution, which can maintain the continuous inhibition of KRAS-dependent signals throughout the dose interval and maximize anti-tumor activity
.
On June 24, the US FDA has granted adagrasib a breakthrough therapy designation for patients with KRAS G12C mutations who have previously received systemic treatment of non-small cell lung cancer (NSCLC)
.
A stage I/Ib and stage II registrable cohort efficacy data (n=51) code-named KRYSTAL-01 showed that the objective response rate (ORR) of adagrasib single-agent 600 mg BID in patients with advanced NSCLC was 45% (23 /51), 70% (16/23) of the patients in remission had a tumor volume reduction of more than 40% compared with baseline, and the disease control rate (DCR) was 96% (49/51)
.
Mirati plans to submit a marketing application to the FDA within this year
On September 19, Mirati announced the results of the KRYSTAL-1 study of adagrasib single agent or combined with cetuximab for the treatment of KRAS G12C mutant colorectal cancer cohort
.
In the adagrasib single-agent group, the PR was 22% (n=45), the DCR was 87%, and the mDOR was 4.
On October 11, Mirati also reached a cooperation with the pharmaceutical giant Sanofi to explore the efficacy of adagrasib and Sanofi's ongoing SHP2 inhibitor SAR442720 for treated NSCLC patients with KRAS G12C mutations
.
There are as many as 10 domestic companies that have applied for KRAS G12C inhibitors.
Among them, Amgen's AMG 510 has been the first to be approved by the US FDA for marketing, and has also been recognized as a breakthrough therapy by CDE in China
.
There are many KRAS inhibitors in the GACOS pipeline, and one of them has entered phase I/II clinical trials
KRAS G12C inhibitor for clinical application in China (Pharma Go)
