[perspective] domestic heavyweight new drugs launched in May

According to the drug intelligence data, in May, the new drugs were approved with 7 acceptance numbers, involving 5 varieties of drugs Here is a brief look at some of the heavier drugs On May 17, the innovative tumor drug of Hengrui (2 billion pounds) - tiopefiglitazine injection, the heavy-duty variety of Hengrui (polyethylene glycol recombinant human granulocyte stimulating factor injection, referred to as 19K) was approved for marketing Hhpg-19k is a polyethylene glycol G-CSF independently developed by Jiangsu Hengrui Pharmaceutical Co., Ltd The drug was modified by PEGylation of G-CSF with reference to the pefigetine of Amgen company, which was proved to be a great success by the pre clinical pharmacokinetic study The Chinese name is commonly used as "thiopefigeristine", which belongs to the innovative medicine of biological products It is reported that the sales volume of the whole G-CSF market in the domestic market is about 4 billion yuan, with short-term G-CSF occupying an absolute dominant position and long-term G-CSF accounting for less than 20% However, according to the global market development trend, the global G-CSF drug market is now more than 5 billion US dollars, and the long-term G-CSF is dominant, with a market share of more than 70% With the adjustment of the medical insurance catalogue in 2017, pegylated recombinant human granulocyte stimulating factor will enter the national medical insurance category B catalogue, and the domestic long-acting G-CSF will enter a rapid development period In view of the therapeutic advantages of Hengrui 19K, it is expected that the product will become another 2 billion pound product of Hengrui after being launched This month, androtinib hydrochloride capsule (trade name: fukewei) of androtinib hydrochloride was approved for marketing, which was used in the third-line treatment of patients with advanced non-small cell lung cancer (NSCLC) Enrotinib is a new type of small molecule and multi-target tyrosine kinase inhibitor, which can effectively act on VEGFR, PDGFR, FGFR, c-kit and other targets, and has dual effects of anti-tumor angiogenesis and tumor growth inhibition It was confirmed by clinical trials that fluconazole is the only single effective oral preparation for antiangiogenic targeted drugs in advanced non-small cell lung cancer ("NSCLC"), with mild adverse reactions and good tolerance Focovide is expected to become the standard drug for three-line treatment in patients with advanced NSCLC The results of clinical research show that arotinib has a good therapeutic effect not only on NSCLC, but also on multiple cancers such as soft tissue sarcoma and ovarian cancer At present, it is actively carrying out multi center clinical trials including the United States (from the listing announcement) the world's first long-acting injection anti AIDS drug made by frontier biology in China, ibovetai for injection, was approved for production on May 17 Ibovetai is a fusion inhibitor of human immunodeficiency virus (HIV-1), which can be used in combination with other antiretroviral drugs Its treatment of AIDS is still a widely used cocktail therapy The innovation will be to replace the current daily oral treatment with weekly injection of drugs The new molecular mechanism of ibovetai makes it very effective for HIV and drug-resistant virus When the drug is used, it only needs to be administered once a week Compared with other anti AIDS drugs, it can significantly improve the compliance of patients with drugs and improve the quality of life of patients "Ibovetai is the world's first long-term anti AIDS drug in phase III clinical trials, marking the improvement of the overall research level of AIDS treatment in China Professor Wu Hao, the lead researcher in the phase III clinical trial of Abbott and director of the infection center of Youan Hospital Affiliated to Capital Medical University, said Zhang Fujie, head of the AIDS clinical working group of the national health and Family Planning Commission, said: "at present, no national drug regulatory agency, including the US Food and Drug Administration (FDA) and other authorities, has approved a long-term anti AIDS drug If it is approved, it is likely to become the first long-term anti AI drug in the world " In April 2018, recombinant cytokine gene-derived protein injection, a 30-year-old new hepatitis B treatment drug pioneered by Jiehua bio group, obtained the new drug certificate and drug registration approval issued by the State Drug Administration for the treatment of chronic hepatitis B On May 25, the national science and technology major special new drug creation special exchange meeting and the global launch conference of Jiehua biological "lefuneng" were held in Beijing, announcing that it can be put into production formally Lefuneng is the first nce (new chemical entity) protein patent drug invested and developed by Jiehua biology after 18 years It is a therapeutic protein with broad-spectrum immune regulation function This time on the market is the efficacy of Lefu in the treatment of hepatitis B, and other indications are in the stage of clinical trial or preclinical research China is a big country of hepatitis B, with a large market demand for treatment At present, there are 93 million hepatitis B carriers, and about 28 million hepatitis B patients need treatment, but the standardized treatment rate is less than 20% Global data, a market research company, predicts that by 2020, the market size of hepatitis B drugs in China will reach 20 billion yuan Through the unique gene technology platform, lefuneng can reconstruct the amino acid sequence system based on the molecular structure of human natural immune regulatory protein The drug has successively obtained invention patents of new drug compounds from dozens of countries such as the United States, the European Union, China, Japan, etc., and has global intellectual property protection "Lefuneng" is the first new type of hepatitis B treatment drug developed successfully in more than 30 years, in addition to oral nucleoside antiviral drugs and human interferon (common and long-acting), and the price of the drug is about 50% of the same kind of imported drugs Beijing Jiehua biological group recently launched the production and sales of "lefuneng" Information source: drug intelligence data, drug intelligence website, Ministry of science and technology, official websites of enterprises