Fruquintinib obtains FDA fast track qualification to accelerate overseas listing process

Recently, Hehuang Pharmaceutical's target anti-cancer drug furinib was granted a fast-track qualification by the FDA for the treatment of patients with metastatic colorectal cancer (mCRC)as part of the accelerated review and approval process established by the FDA, fast-track eligibility means that drugs will receive more attention from the FDA during the research and development and registration process, shortening the time for new drug development and marketingThe FDA's fast-track eligibility for fda-granting will undoubtedly accelerate the drug's U.Slaunch and bring new treatmentoptions to patients with metastatic colorectal cancer overseasNew Hope for Targeted Treatment of Patients with Advanced Colorectal Cancer in Chinareported that in China, there are about 376,000 new cases of colorectal cancer and about 191,000 deaths each year in Chinaas an oral inhibitor of the highly selective vascular endothelial growth factor receptor of the small molecule serium, the main target of the furanquine is the VEGFR kinase family, which inhibits the proliferation, migration and tube cavity formation of vascular endothelial cells by inhibiting the proliferation, migration and tube cavity formation of vascular endothelial cells by inhibiting the formation of new tumors and finally exerting the tumor growth effectSeptember 2018, equinequinibini was first approved for sale in China, the product is called Aiyoute, used in single-drug therapy to undergo chemotherapy based on fluorourery, oshariplatin and Iliticon, as well as previously received or unsuitable for resistance Patients with metastatic colorectal cancer (mCRC) with vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) treatment (RAS wild type) have brought new hope to the targeted treatment of patients with advanced colorectal cancer in Chinabreak through the dilemma of third-line treatment of metastatic colorectal cancer
the domestic multicenter, randomized, double-blind, placebo-controlled phase III study freSCO was designed to assess the efficacy and safety of treating patients with metastatic colorectal cancer who failed second-line standard chemotherapydata showed that the median total survival of patients in the epinemine group was 9.3 months, a significant increase of 2.7 months, a 35% reduction in the risk of death compared to the placebo group;noteworthy, FRESCO's full-text study was published in the Journal of the American Medical Association, the first clinical study of new anti-tumor drugs in China published in this leading international medical journal, showing the recognition of the international academic community for the enoquineHealth Insurance Support Improve drug accessibilityneed to be concerned that, clinically, nearly half of colorectal cancer patients are diagnosed with advanced disease at the time of their first diagnosisBefore the domestic approval of the domestic market of the furanquine, the traditional first-line second-line standard treatment failure, effective treatment means are limited, the primary goal of patient treatment is still to extend survival, improve the quality of lifeNovember 2019, the results of the national health insurance negotiations and the latest health insurance catalog announced that the introduction of furanquine in the national health insurance drug Category B directory, 68% lower than the previous price, greatly reducing the financial burden of patients, while health insurance support to improve access to drugs, will benefit more patients in the country, improve the quality of life of patientsthe domestic clinical layout of the , according to the information displayed by the Chinese drug clinical trial registration and information publicity platform, the furanquine has registered 17 clinical trials in China In addition to approved colorectal cancer, clinical adaptation salso covers non-small cell lung cancer, advanced stomach cancer, advanced stomach or GEJ adenocarcinoma Among them, in the phase III stage of clinical research there are two, respectively, the treatment of non-squamous cell lung cancer, the combination of pyridine and cyanosis for the treatment of advanced gastric or GEJ adenocarcinoma, respectively, is expected to become domestic and colorectal cancer after the declaration of the new indications in the combined drug treatment plan, the efficacy of the combination of chloroquine and PD-1 monoanti-strong is expected Up to now, the equinolquinibinib has carried out joint drug use studies with Baiji Shenzhou for reilly zumas, Cinda BioCindi singrodites and Jia and biogenthrosmin overseas phase III clinical research FRESCO-2 in addition to domestic clinical studies, and Huang Pharma has launched a global multi-center, blank control phase III clinical study FRESCO-2 overseas, to recruit 522 subjects, in order to evaluate the safety and effectiveness of the third-line treatment of human patients with protermini, set the main clinical endpoint for the total survival of patients (OS) plan, the FRESCO-2 clinical study is expected to be completed by the end of 2022, and the data will be used to support the overseas listing of furanquine.