Special varieties of "Major new drug creation" approved for marketing in the first half of 2018

In 2006, the State Council released the outline of national medium and long term science and technology development plan (2006-2020), which made an overall plan for China's science and technology development in the next 15 years, and listed 16 major national science and technology projects Major projects are major strategic products, key common technologies and major projects completed within a certain time limit through core technology breakthroughs and resource integration to achieve national goals, which are the top priority of China's scientific and technological development Among them, "major new drug creation" has been listed as one of the three major scientific and technological projects related to biotechnology Its main objective is to develop a batch of major drugs, improve the national drug innovation system, enhance the ability of independent innovation, accelerate the transformation from imitation to creation, and develop from a "pharmaceutical power" to a "pharmaceutical power" aiming at 10 categories (species) of major diseases seriously endangering the health of Chinese people 。 The special project is implemented in stages according to the three five-year plan On August 19, 2008, the first meeting of major science and technology special project of "major new drug creation" was held in Beijing Since its implementation in 2008, the "special project" has made remarkable achievements in promoting innovative drug research and development and leapfrog development of the pharmaceutical industry, and filling in the national strategic gap The number of class I new drugs spawned is five times of that before the implementation of the "special project" In the past 10 years, 1641 special projects (subjects) have been deployed and 14.3 billion yuan has been invested by the central government 94 kinds of special support have obtained new drug certificates, 28 of which are first-class new drugs on the market Introduction to "major new drug creation" special varieties in the first half of 2018 can be described as a great harvest of major special varieties, with four first-class new drugs approved for listing 1 General name of recombinant cytokine gene-derived protein: recombinant cytokine gene-derived protein injection trade name: lefuneng R & D enterprise: Jiehua biology approved for listing: April 12, 2018 Recombinant cytokine gene-derived protein is a new type of immune regulatory protein molecule It is derived from the unique gene technology platform and the amino acid sequence system transformation based on the molecular structure of human natural immune regulatory protein The protein molecule is named novaferon in English and belongs to the class of nce (new chemical) Entity), which through more efficient regulation and enhancement of immune function, shows the effect of treating viral diseases, malignant tumors and autoimmune diseases, belongs to "immunotherapy" drugs It has obtained invention patents from dozens of countries, such as the United States, the European Union, Japan and China, and has global intellectual property protection On April 12, 2018, under the support of national science and technology major special project for major new drug creation, it was approved to be listed through special review procedures for the treatment of chronic hepatitis B "Lefuneng" has been developed in the laboratory since 2000, approved clinical application in 2009, and approved to be listed in 2018 It has gone through 18 years The approved dosage form is injection with the specification of 10 μ g / 1.0 ml / bottle "Lefuneng" is the first new type of hepatitis B treatment drug developed successfully in more than 30 years, except for two categories of drugs, i.e oral nucleoside antiviral drugs and human interferon (common and long-acting) Clinical research shows that about 30% of the patients treated with "lefuneng" for 3 months can achieve the effect of inhibiting the replication of hepatitis B virus in hepatocytes, about 40% of the patients treated with "lefuneng" for 6 months can achieve the effect, and about 50% of the patients treated with "lefuneng" for 9 months can achieve the effect, which is far superior to the effect of existing hepatitis B treatment drugs 2 General name of arotinib: arotinib hydrochloride capsule trade name: focovi R & D enterprise: Zhengda Tianqing approved for listing: on May 8, 2018, arotinib is a new small molecule multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-kit and other kinases, and has the effect of anti-tumor angiogenesis and tumor growth On May 9, 2018, with the support of national science and technology major special project for major new drug development, androtinib was approved to be listed through priority review procedure for the treatment of advanced or metastatic non-small cell lung cancer The approved dosage form is capsule with specifications of 8 mg, 10 mg and 12 mg From the application for compound patent in 2007, the application for clinical application in 2010, the approval for clinical application in March 2011, the completion of the application for production of clinical trials in 2017, to the approval for listing in 2018, the R & D process is 11 years According to the results of the alter 0303 study published by ASCO 2017, 437 patients with advanced NSCLC who had received at least two previous systemic chemotherapy were randomly treated with arotinib (n = 294) or placebo (n = 143) until disease progression or intolerable toxicity The results showed that the orotinib group significantly prolonged OS (9.63 vs 6.30 months) and PFS (5.37 vs 1.40 months), and significantly increased orr (9.18% vs 0.7%) At present, arotinib is the only single effective oral preparation among the anti angiogenesis targeted drugs for advanced non-small cell lung cancer, with less adverse reactions and better patient tolerance It is expected to become the standard drug for the third-line treatment of advanced non-small cell lung cancer In addition, the multi center clinical study of arotinib on multiple cancer species such as soft tissue sarcoma and ovarian cancer is also in progress 3 General name of aiboweitai: aiboweitai for injection commodity name: aikoning R & D enterprise: Frontier biology approved for listing: May 23, 2018, aiboweitai is the world's first long-term anti AIDS fusion inhibitor, China's first original anti AIDS new drug, independently developed by frontier biology, with global original intellectual property rights On May 23, 2018, under the support of national science and technology major special project for major new drug creation, it was approved to be listed through special review and priority review procedures, and approved to be used in combination with other antiretroviral drugs to treat HIV-1 infected patients who still have virus replication after antiviral treatment The approved dosage form is injection with the specification of 160 mg / bottle Ibovetai has been on the market for 16 years since its research and development, with more than 150 researches, and has been continuously supported by major new drug creation projects of the 11th five year plan, 12th Five Year Plan and 13th five year plan Clinical phase III trials showed that once a week, patients with HIV who had failed in the first-line treatment were injected with ibovetam combined with lopinavir / ritonavir, the efficacy of which was equivalent to or better than the second-line drugs recommended by the World Health Organization (lopinavir or ritonavir + lamivudine + tenofovir or abacavir or zidovudine twice a day) Its advantages mainly lie in the low frequency of medication (once a week), high resistance barrier, high safety, small side effects, etc., which can significantly improve the compliance of patients with medication and improve the quality of life 4 General name of danorivir: danorivir sodium tablet trade name: gonovi R & D enterprise: Geli pharmaceutical approved for listing: June 8, 2018 Danorivir is a new generation of NS3 / 4A protease inhibitor, the first class 1 new drug for oral treatment of hepatitis C developed in China Under the support of major science and technology projects of "major new drug creation", it was approved to go on the market on June 8 through special review and priority review procedures, and the dosage form was approved as tablet, with the specification of 100 mg Danorevir has carried out 37 clinical studies in the world, and more than 2600 patients have been enrolled in the group The results of phase III clinical trials completed in mainland China show that after 12 weeks of treatment, the cure rate (svr12) in patients with gene 1 non cirrhosis is 97%, which is higher than 91% of the cure rate of some foreign similar products, with good safety and tolerance, and half of the treatment course is shortened; in Taiwan, Europe and the United States, China The data of clinical trials in Thailand, Korea and other countries and regions showed that the cure rate was 91% in patients with genotype 1 cirrhosis and 100% in patients without genotype 4 cirrhosis Postscript with the continuous improvement of the level of pharmaceutical research and development in China, the ability of independent innovation has been greatly improved More and more local pharmaceutical enterprises have changed from imitation to creation, and more and more class a new drugs have been born! The establishment of the national "major new drug creation" project provides certain financial support for the research and development of new drugs; meanwhile, the optimization of the review channel provides a convenient channel for the early listing of new drugs In the future, we look forward to more global new drugs blooming in the motherland! Reference source: http://www.nmp.gov.cn/