Zejing Pharmaceuticals "Donafinil" is planned to be included in the priority review

On October 12, the CDE announced its plan to include zealopharmaceut 1 new drug, toluene sulfonate donaphetamine tablets, in the priority review and approval (acceptance number: CXHS2000010) for the treatment of advanced (unsure or metastatic) hepatocellular carcinoma.
toluene sulfonate donafinib tablets are oral multi-target, multi-kinase inhibitors and small molecule anti-tumor drugs developed by Zetsin Pharmaceuticals with independent intellectual property rights, and belong to class 1 new drugs.
Preclinical pharmacological studies have confirmed that donafinib inhibits the activity of vegFR, PDGFR and other subjects tyrosine kinases, as well as a variety of Raf kinases directly, and inhibits downstream Raf/MEK/ERK signal conduction path, inhibits tumor cell proliferation and tumor blood vessel formation, and plays a multi-inhibition, multi-target blocking anti-tumor effect.
The new drug market application to be included in the priority review is mainly based on the results of the open, randomized, parallel control, multi-center II./III. phase clinical study (trial code ZGDH3) based on the first-line treatment of advanced hepatocellular carcinoma.
ZGDH3 trial was a phase II./III. registered clinical study (conducted simultaneously by 37 research centers and included a 1:1 randomized group of donovany therapy groups or sorafinist control groups).
main endpoints are total lifetime (PFS), objective mitigation rate (DCR), safety and tolerance.
January 1 this year, Zee-Pharma announced that the ZGDH3 study had been successful, reaching the pre-set primary endpoint and safety results.
In patients with non-surgical or metastatic advanced hepatocellular carcinoma who had not received systematic treatment, the medium total survival (mOS) of the donovine treatment group was significantly better than that of the controlled drug sorafine, resulting in statistically significant and clinically significant extensions.
group showed better safety in terms of the rate of adverse events at level 3 and above, and the rate of adverse events associated with drug-related drug suspension or reduction.
no new or more than expected security issues in the test.
detailed data on the study was presented at the 2020 ASCO Conference (Summary: 4506).
At the same time, the official website of Zee-Yuan Pharmaceuticals shows that clinical studies are under way on a variety of malignant tumors such as the treatment of hepatocellular carcinoma, advanced colorectal cancer and iodine refractive differentiated thyroid cancer, phase I clinical treatment of nasopharyngeal cancer, and the combined treatment of advanced hepatocellular carcinoma by Donaphone and anti-PD-1.
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