China Guide Authoritative Voice - Donafini included in CSCO 'Primary Liver Cancer Diagnosis And Treatment Guide' to receive I-level expert recommendation.

On July 3, 2020, the Chinese society of Clinical Oncology (CSCO) officially released the new version of the guidelines for diagnosis and treatment of primary liver cancer.in this guideline update, donafinil, an innovative drug independently developed by Suzhou Zejing biopharmaceutical Co., Ltd., a local pharmaceutical company, has been listed as the first-line treatment drug for advanced hepatocellular carcinoma (HCC), and is recommended by grade I experts and type 1A evidence.this is the first and only national first-line molecular targeted drug for the treatment of liver cancer after sorafenib and rivatinib. It has epoch-making scientific significance and practical value for the treatment of liver cancer in China and even the world! According to statistics, there are 466000 new cases and 422000 deaths each year, which are more than half of the world's, posing a serious threat to people's lives and health."China primary liver cancer registration and research project (CLCS)" shows that HCC in China is significantly different from that in Europe and the United States, with a high degree of heterogeneity. The proportion of HCC related to hepatitis B virus infection is relatively high, and 80% of HCC patients have reached the middle and late stage at the time of initial diagnosis, and have lost the chance to root; at the same time, most patients have basic liver disease (hepatitis and cirrhosis) and poor liver function, Results in treatment difficulties, poor treatment effect, the survival time of patients is very short.therefore, the diagnosis and treatment of liver cancer in China can not completely copy the experience of foreign countries.following the approval of sorafenib for the first-line treatment of HCC in Europe and the United States in 2007, a series of large-scale clinical studies on the first-line treatment of advanced HCC have been carried out by scholars all over the world, but all of them failed.it was not until 2018 that the second first-line targeted therapy, rivatinib, was approved for marketing through the study on the overall survival time not inferior to sorafenib.it is reported that donafinil has been included and strongly recommended in this CSCO guideline for the diagnosis and treatment of primary liver cancer, which is based on the excellent results of the multicenter ll / ll phase clinical study (zgdh3 trial) of donafinil and sorafenib in the first-line treatment of advanced HCC published during the ASCO annual meeting recently.the study was independently designed and organized by famous tumor experts Qin Shukui and Professor Bi Feng. A total of 668 HCC patients in China were included in this study. It is the largest clinical study on liver cancer in China by far.it is worth emphasizing that compared with the reflect, checkmate 459 and imbrave150 studies, zgdh3 trial had worse baseline status and more complicated conditions, including a higher proportion of HBV etiology, higher proportion of BCLC stage C and child Pugh B grade, which was close to the actual status of patients with advanced HCC in China and more in line with the national conditions.the results of zgdh3 trial showed that the main end point of the comparative study - overall survival (OS), donafinil group was significantly better than sorafenib group, MOS was 12.1 months vs. 10.3 months (risk ratio was 0.831, 95% confidence interval was 0.699-0.988; P = 0.0363).donafinil is the first and only drug to achieve excellent OS results in a phase III clinical study comparing sorafenib and sorafenib head-to-head in the world.at the same time, in donafinil group, the incidence of adverse events (AE) ≥ 3, drug-related adverse events (ADR) and AE leading to drug suspension and reduction were significantly lower in donafinil group than in sorafenib group, that is, donafinil is not only more effective than sorafenib, but also safer.just recently, the world's top oncology event, the American Society of Clinical Oncology (ASCO) annual meeting, zgdh3 research was selected as the oral report from more than 6300 contributions. It is also the only heavyweight research selected in the fields of pancreatic cancer, esophageal cancer and liver cancer in this ASCO conference, which shows its high gold content! The successful research and development of donafinil and the excellent results of zgdh3 trial represent a major breakthrough of domestic innovative drugs in the field of liver cancer treatment, and also mean that the deadlock of "monopoly" of imported targeted drugs in the first-line treatment of advanced HCC in China will be completely broken. Zejing pharmaceutical has submitted donafinil's application for listing to the National Drug Administration, and has been officially accepted by the drug evaluation center; If the process is smooth, it is expected to be approved for marketing and have the first-line treatment indications for advanced liver cancer by the end of the year.in the update of CSCO guidelines for diagnosis and treatment of primary liver cancer in 2020, donafinil, which is waiting for the market, is listed as the first-line expert recommended drug for advanced HCC patients in advance, which not only reflects that CSCO mainly based on evidence-based medical evidence and timely absorption of new progress in clinical oncology, but also fully considers that donafinil is the first choice after the drug is approved The application of time in clinical practice under the guidance of the guidelines enables the majority of patients to use new drugs and good drugs as soon as possible, which reflects the strong support for the innovation achievements of national pharmaceutical enterprises and Chinese scholars! We sincerely hope that donafinil will be approved for the market as soon as possible, so that many Chinese patients with liver cancer can benefit from it as soon as possible. Br / >doxycycline is a new kind of new anti-tumor drug with the intellectual property rights of doxycycline.preclinical pharmacological studies have confirmed that donafinil can not only inhibit the activities of VEGFR, PDGFR and other receptor tyrosine kinases, but also directly inhibit a variety of RAF kinases, affecting the downstream Raf / MEK / ERK signal transduction pathway, thus inhibiting the proliferation of tumor cells and the formation of tumor blood vessels, and playing an anti-tumor effect of dual efficient inhibition and multi-target blocking. donafinil is a new generation product, which has better pharmacokinetic and pharmacodynamic properties than sorafenib. The zgdh3 clinical trial fully proves the advantages and characteristics of donafinil, which is expected to become an important choice for the first-line treatment of HCC.