Zejing Pharmaceutical's application for the first class of new drugs for liver cancer is planned to be included in the priority review

Screenshot source: CDE official website Donaphini is an oral multi-target, multi-kinase inhibitor-type small molecule anti-tumor drug developed by Zeppeni Pharmaceuticals, which belongs to class 1 new drug.
Preclinical pharmacological studies have confirmed that the drug can inhibit the activity of VEGFR, PDGFR and other subjects tyrosine kinase, but also directly inhibit a variety of Raf kinases, and inhibit downstream Raf/MEK/ERK signaling path, inhibit tumor cell proliferation and tumor blood vessel formation, play a multi-inhibition, multi-target blocking anti-tumor effect.
, according to an earlier press release issued by Zee-Pharma, the application for the new drug is based on the results of the trial ZGDH3.
ZGDH3 is an open, randomized, parallel control, multi-center Phase 2/3 clinical study led by Professor Qin Shuxuan, Vice President of the Chinese Society of Clinical Oncology (CSCO), to explore the effectiveness and safety of donapheal tablets in first-line treatment in patients with advanced hepatocellular carcinoma.
the main endpoints of the study were total lifetime (OS), and the secondary endpoints included indicators such as no progression survival time (PFS), objective mitigation rate (ORR), disease control rate (DCR), safety and tolerance.
test results show that the ZGDH3 study met the preset main endpoint and statistical requirements.
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.
addition, the Donaforinie 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.
According to the official website of Ze-Yuan Pharmaceuticals, in the 2020 edition of the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer published by the Chinese Society of Clinical Oncology in July this year, Donaphini has been listed as a first-line treatment drug for advanced hepatocellular carcinoma and is recommended by Class I experts and Class 1A evidence.
Photo Source: Zee-Pharma's website It's worth noting that the summary of ZGDH3's findings was also successfully included in this year's oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO).
According to the Chinese Society of Clinical Oncology, this is the first time in a decade that a large-scale clinical study of advanced hepatocellular carcinoma, developed independently by China and led by Chinese scholars, has presented results and data to the world at the ASCO Conference.
In addition to liver cancer, zeitone Pharmaceuticals is currently conducting key clinical studies on the treatment of advanced colorectal and thyroid cancers in Donaphinib, and is also actively promoting new research on the combination of Donaphinib PD-1/PD-L1 monoantigenic treatment of a variety of tumors.
: The drug review center (CDE.Retrieved Oct 12,2020, from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Retrieved May 12, 2020, from s.3. Donaphini was recommended by I.D. experts in CSCO's Guidelines for the Diagnosis and Treatment of Primary Liver Cancer. Retrieved July 03, 2020, from.