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    Home > Medical News > Latest Medical News > The first anti-angiogenic monoclonal antibody patent expires and the domestic biosimilar drug will be on the market soon!

    The first anti-angiogenic monoclonal antibody patent expires and the domestic biosimilar drug will be on the market soon!

    • Last Update: 2019-04-09
    • Source: Internet
    • Author: User
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    As a new targeted treatment strategy, anti angiogenic drugs targeting vegf-vegfr can cut off the nutrition source of tumor cells and inhibit the growth of tumor, correct the abnormal structure and function of tumor blood vessels, increase the permeability of anti-cancer drugs and improve the anti-cancer effect Fig 1 anti angiogenic drugs of tumor cells (a), normal tissues (b) and cancer tissues (c) are mainly divided into two categories: one is macromolecular monoclonal antibody, such as bevacizumab; the other is small tyrosinase inhibitors, such as apatinib, arotinib, furaquitinib, etc Table 1 the high price of Avastin, an anti angiogenic target drug, still limits its access rate Bevacizumab (avidin), as the first anti angiogenic monoclonal antibody in the world, can inhibit the proliferation and activation of vascular endothelial cells and play an anti angiogenic and anti-tumor role by combining with VEGF It has been widely used in the treatment of colorectal cancer, lung cancer, ovarian cancer, cervical cancer and other cancer In the past 15 years, the global sales volume has reached about 500 billion yuan (US $77 billion), which has become the basic drug for anti-tumor treatment in European and American markets Figure 2 global sales of bevacizumab in 2010, avidin was listed in China Since its listing, its sales volume has maintained steady growth At the end of 2017, the price of Avastin was greatly reduced and included in the medical insurance However, the high drug unit price significantly restricted the drug access rate, and the use rate among the suitable population was less than 20% Figure 3 sales volume of bevacizumab PDB in China avidin domestic bio similar drugs will accelerate the listing of bevacizumab patent will expire in 2019, and the research and development of bio similar drugs are in full swing, among which Qilu pharmaceutical and Cinda bio are the fastest growing In October 2018, Qilu pharmaceutical's ql1101 was included in the 33rd batch of priority review procedure drug registration applications, and the first bevacizumab bio similar drug will be accelerated to market In addition, Xinda biology ibi305, Jiahe biology gb222, Hengrui medicine bp102, Zhengda Tianqing tq-b2302, etc are actively carrying out phase III clinical trials Table 2 research and development progress of bevacizumab biological analogues in China molecular TiNi, indications still need to continue to expand tumor angiogenesis is the key step of solid tumor development and metastasis, small TiNi anti angiogenic drugs, inhibit VEGF signal pathway in the cell, inhibit tumor angiogenesis, inhibit tumor growth Apatinib, the world's first small molecule anti angiogenic targeted drug proved safe and effective in advanced gastric cancer, is also the only oral drug targeted for advanced gastric cancer, which can significantly improve patients' compliance Apatini has been listed for three years, and its sales volume has doubled In addition, it was included in the medical insurance in 2017, and maintained a strong growth rate in 2018 It is expected that the sales volume of apatini market will exceed 3 billion yuan in 2020 Figure 4 sales volume of apatinib PDB sample medicine androtinib is the first approved third-line treatment drug for advanced NSCLC in China and the only one in the world It was included in the 2018 edition of CSCO guidelines for the diagnosis and treatment of primary lung cancer at the beginning of its listing The results of clinical trials showed that compared with placebo group, the PFS and OS of patients in the arotene group were significantly prolonged by 3.8 months and 2.4 months respectively With its inclusion in the medical insurance reimbursement catalog in 2018, its market penetration will further improve in the future, and the peak sales volume is expected to reach 3 billion yuan Compared with placebo group, the survival time of colorectal cancer patients in the group of taking furaquinidine can be significantly prolonged by 2.7 months, and the liver toxicity is the lowest of the same kind of drugs While affirming the three TiNi drugs, we need to put forward higher requirements: at present, the approved indications of the three drugs are single, and the indications of other cancer species need to be expanded urgently, and the relevant clinical trials of their respective manufacturers are in full swing Table 3 clinical progress of target drug indications of domestic anti angiogenic TKI With the expiration of the patent of the imported anti angiogenic monoclonal antibody, more cancer patients will benefit from the listing of domestic bio similar drugs in the future: combined with other anti-cancer drugs, to maximize the inhibition of tumor cell proliferation and metastasis, to achieve comprehensive anti-cancer! Source: public information, PDB, Bloomberg, Shenwan Hongyuan, etc.
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