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    Home > Active Ingredient News > Drugs Articles > After Sorafenib, Bayer Regorafenib is also dangerous, and the first imitation has been reported.

    After Sorafenib, Bayer Regorafenib is also dangerous, and the first imitation has been reported.

    • Last Update: 2021-07-01
    • Source: Internet
    • Author: User
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    A few days ago, Yangtze River Pharmaceutical Group 's application for the listing of 4 types of generic drugs for Regorafenib tablets was accepted by CDE, becoming the first domestic company to submit an application for the listing of generic drugs for this category
    .

    The original research regorafenib (Stivarga) is a multi-target kinase inhibitor developed by Bayer.
    In addition to blocking the pro-angiogenic kinase VEGFR 1-3, it can also block a variety of kinases in the tumor microenvironment, such as TIE-2, RAF-1, BRAF V600, KIT, RET, PDGFR and FGFR, these kinases alone and in combination regulate tumor growth, matrix microenvironment formation and disease progression
    .

    So far, Stivarga has been approved for multiple indications.
    (1) Those who have received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, anti-VEGF therapy, and if they are wild-type KRAS patients, receive anti-EGFR therapy Patients with metastatic colorectal cancer (CRC) (FDA 2012/09, EMA 2013/09); (2) Patients with gastrointestinal malignant stromal tumors (GIST) who cannot be removed surgically and Gleevec and Sutent drugs are ineffective (FDA 2013/ 02, EMA 2014/07); (3) Liver cancer patients who have been treated with NEXAVAR (Sorafenib), but their condition is still not effectively controlled (FDA 2017/04, EMA 2017/08)
    .

    In addition, in June 2019, Bayer cooperated with CStone Pharmaceuticals to evaluate the safety, tolerability, and pharmacokinetics (PK) of Stivarga and CStone's PD-L1 monoclonal antibody CS1001 in the treatment of multiple cancers including gastric cancer.
    And anti-tumor activity
    .


    In July of the same year, Bayer signed a clinical cooperation agreement with Bristol-Myers Squibb and Ono Pharmaceuticals to evaluate the efficacy of Stivarga combined with Opdivo in the treatment of microsatellite stable metastatic colorectal cancer (MSS mCRC)


    Stivarga is jointly promoted by Bayer and Onyx Pharmaceuticals (acquired by Amgen in August 2013) and has been approved for listing in more than 100 countries around the world, benefiting more than 200,000 cancer patients
    .


    According to Bayer’s financial report, the drug has maintained an overall growth trend since its launch, with sales reaching 475 million euros in 2020


    In China, the original research regorafenib (trade name: Baiwango) was approved by the NMPA in May 2017 for the treatment of advanced/metastatic colorectal cancer and gastrointestinal stromal tumors, and was approved again in January 2018 Yu treated patients with hepatocellular carcinoma who had received sorafenib treatment and entered the national medical insurance in October 2018, and successfully renewed the 2020 national medical insurance, and the price was reduced again
    .

    In the field of liver cancer treatment, regorafenib, as the first innovative second-line targeted therapy drug, has opened the era of full management of liver cancer drugs.
    Data from Asian populations show that patients in the monotherapy group have a survival time of up to 16.
    3 months.
    Data from China shows Sola The survival time of the fenib+regorafenib sequential regimen is as long as 35.
    3 months; in the field of metastatic colorectal cancer treatment, Chinese real-world studies have shown that the survival benefit of the 120mg regorafenib group is up to 16.
    7 months
    .


    At present, regorafenib is the only second-line standard treatment for liver cancer recommended by the 2019 National Guidelines for Primary Liver Cancer and the third-line standard treatment recommended by major standard guidelines for colorectal cancer and gastrointestinal stromal tumors


           According to data from Minai.
    com, the terminal sales of Rigofinil in domestic urban public hospitals in 2018 and 2019 were 30.
    17 million yuan (+13017.
    39%) and 376 million yuan (+1146.
    57%), respectively, and sales reached a new high in 2020.
    In the first half of the year alone, sales reached 322 million yuan
    .

           At present, according to the insight database, many domestic companies have begun to deploy the regorafenib market.
    Among them, Yangtze River Pharmaceutical has made the fastest progress and has submitted a listing application.
    According to its bioequivalence test, it is speculated that the declared indication is colorectal cancer.
    , Gastrointestinal stromal tumor and hepatocellular carcinoma
    .


    Qilu Pharmaceutical, Nanjing Zhengda Tianqing, Beijing Shuanglu Pharmaceutical, and Hunan Kelun Pharmaceutical are conducting BE trials.


           In addition to regorafenib, Bayer also has an oral multi-target kinase inhibitor-sorafenib (Nexavar)
    .


    Nexavar was approved by the FDA in December 2005 for the treatment of patients with advanced renal cell carcinoma (RCC) who had previously failed interferon alpha or interleukin 2 (IL-2) treatment or were considered unsuitable for this type of therapy, and was subsequently approved in November 2007.


           The original research Sorafenib (trade name NEXAVAR) was approved in China in September 2006 for the treatment of advanced/metastatic renal cell carcinoma, and was subsequently approved for the treatment of hepatocellular carcinoma (2008/06) and Thyroid cancer (2017/03)
    .


    Sorafenib entered the national medical insurance in 2017 and successfully renewed the national medical insurance in 2020


           According to the insight database, at present, Jiangxi Shanxiang Pharmaceutical and Chongqing Yaoyou Pharmaceutical have obtained sorafenib generic drug production approvals on August 5 and 12, 2020
    .


    In addition, Chia Tai Tianqing, Yangzijiang Pharmaceutical and Furen Pharmaceuticals are conducting BE trials, and 8 companies including Hausen Pharmaceuticals and Qilu Pharmaceuticals have been approved for clinical trials


           In addition, China's Jing Ze pharmaceutical self-developed multi-target kinase inhibitor - Dona sorafenib (ie deuterated sorafenib) have been reported in domestic production (related to the admissibility number: CXHS2000010), indicated for the treatment of first-line treatment Advanced (inoperable or metastatic) hepatocellular carcinoma
    .


    The results of the ZGDH3 test showed that compared with sorafenib, in patients with inoperable or metastatic advanced hepatocellular carcinoma who had not received systemic treatment, the median overall survival (mOS) of the donafenib treatment group was significantly better than that of sorafenib The control drug Sorafenib treatment group achieved a statistically significant and clinically significant prolongation, and the Donafenib group had a grade 3 or above adverse event incidence, drug-related drug-related discontinuation or dose reduction The incidence of adverse events and other aspects showed better safety


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