-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
- Cosmetic Ingredient
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On October 12, the website of the Drug Review Center (CDE) of the State Drug Administration of China announced that the application for the listing of the new drug toluene sulfonate donaphine tablets of Ze-Yuan Pharmaceuticals 1 is to be included in the priority review, and the proposed adaptation of this application is - for the treatment of advanced (unable to operate or metastatic) hepatocellular carcinoma.
means not only that Donaini is expected to accelerate its approval in China, but also that Zee-Pharma is on track to welcome the first drug to be approved for sale.
screenshot source: CDE official website Donaphini is an oral multi-target, multi-kinase inhibitor-type small molecule anti-tumor drug developed by Zeppeni Pharmaceuticals, belonging to a new class of drugs.
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: Zeal Pharmaceuticals Website It's worth noting that a summary of ZGDH3's findings was also selected for oral presentation at this year's 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.
.