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On May 31, the NMPA official website showed that Zejing Pharmaceutical’s Class 1 new drug "Donafinil Tosylate Tablets" has completed the listing review and entered the approval status.
Donafinil tosylate tablets are oral multi-target, multi-kinase inhibitors, small molecule anti-tumor drugs with independent intellectual property rights developed by Zejing Pharmaceuticals, and belong to Class 1 new drugs.
Preclinical pharmacological studies have confirmed that Donafenib can not only inhibit the activity of VEGFR, PDGFR and other receptor tyrosine kinases, but also directly inhibit various Raf kinases, and inhibit the downstream Raf/MEK/ERK signal transduction pathway , Inhibit the proliferation of tumor cells and the formation of tumor blood vessels, and exert the anti-tumor effect of multiple inhibition and multi-target blocking.
This new drug marketing application is mainly based on the results of an open, randomized, parallel controlled, multi-center phase II/III clinical study of Donafenib tosylate tablets for the first-line treatment of advanced hepatocellular carcinoma (trial code ZGDH3).
The above-mentioned clinical trial results were selected as an oral report at the 2020 ASCO annual meeting.
From March 2016 to April 2018, a total of 668 patients were enrolled (ITT set, 334 cases in each group), of which 659 cases (328 vs 331 cases) were included in the FAS set.
In the two groups, 191 cases (57.
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