Progress of major new drug development projects in China in 2016

1 In October 2016, conbercept eye injection, a national class I new biological drug developed by Kanghong in Chengdu, was approved by FDA It can directly carry out phase III clinical trials in the United States to treat wet age-related macular degeneration, marking that conbercept has been affirmed in quality standards, drug efficacy and safety in the process of entering the international market In 2015, conbercept's sales volume was 267 million yuan, and in the first half of 2016, the sales volume was 224 million yuan Picture from: ppt 2 pegabin, director of Wang Junzhi, Chinese Academy of inspection, October 2016, pegabin, a long-acting interferon with independent intellectual property rights and effective treatment of viral hepatitis, was officially launched nationwide Xiamen Tebao Bioengineering Co., Ltd broke through the long-term modification technology of macromolecular drugs and developed "pegabin", breaking the monopoly of similar products abroad The cost of quality adjusted life years for patients with genotype 1 and 2 / 3 chronic hepatitis C in China was 8008.98 yuan and 4999.77 yuan, respectively, the cost of general interferon was 16505.99 yuan and 6463.87 yuan, and the cost of PEG IFN α - 2a was 9015.14 yuan and 5846.34 yuan, respectively 3 The class 1.1 new drug "nanofloxacin malate capsule" was approved in June 2016 and launched in October 2016 The drug is a new fluoroquinolone free drug, which was developed by Zhejiang Pharmaceutical and Taijing Pharmaceutical Co., Ltd its phase I-III clinical trials and efficacy evaluation were led and completed by the GCP platform of Huashan Hospital Affiliated to Fudan University supported by the national major new drug creation project Note: if the CDE review report is required, you can log in to CDE to download the nyloxacin malate, which is developed by Procter & gambles Inc of the United States, and authorize Taijing pharmaceutical research and development (Beijing) Co., Ltd to develop in China At the beginning of the application for clinical trials in China, the application materials stated that the phase I clinical trial of nanofloxacin malate capsule had been completed in the United States, and the phase II clinical trial would be started in the second half of 2006 No information about norfloxacin was found in the literature at home and abroad 4 Avidini, a new anticancer drug developed by Hangzhou Essen biology, started phase II clinical research in July 2016 Ivetinib has independent intellectual property rights and has carried out clinical research in China and the United States simultaneously Compared with previous EGFR inhibitors, EGFR inhibitors have less side effects and strong resistance to drugs, which can be used to treat drug-resistant advanced lung cancer In the wclc in December 2016, Eisenberg released the latest efficacy and safety data of phase I / II dose increase and clinical expansion test of ivetinib The purpose of the study was to determine the safety, antitumor activity and phase II dose of avetinib for NSCLC patients with T790M positive mutation after failure of the first generation EGFR-TKI treatment At the meeting, the researchers said that based on the good efficacy and tolerance of ivetinib, the study selected 300mg bid as the phase II recommended dose 5 under the special support of national "11th Five Year Plan" and "12th Five Year Plan" major new drug creation, novaferon, a national class I new drug for hepatitis B treatment, was officially put into production in Qingdao Laoshan District, July 2016 Compared with the similar protein drugs, lefuneng has the international leading level in antiviral and antitumor functions and activities In February 2017, the company's official website said that Lefu could successfully pass the clinical data verification of the State Food and drug administration Reference: http:// under the special support of national "11th Five Year Plan" and "12th Five Year Plan" major new drug development, the national class 1 new drug "ibovetai", which is developed by cutting-edge biology for injection, long-term antiviral and AIDS treatment, formally submitted the new drug application to CFDA in June 2016 and was officially accepted In November 2016, the product obtained priority approval and accelerated review At present, the verification procedure for phase III clinical trial data of the drug has been started At the end of 2016, the company completed the round C financing of RMB 300 million 7 The world's first enterovirus 71 inactivated vaccine (human diploid cells) (EV71 inactivated vaccine) world first vaccination ceremony was held in Gaobeidian community health service center, Chaoyang District, Beijing on March 22, 2016 Note: the CDE review report can be downloaded by CDE The product is safe and acceptable The rate of protection for hand foot mouth disease caused by EV71 is 97.3% This indicates that the post marketing will have a certain effect on reducing the incidence rate of hand foot mouth disease, and has certain clinical benefits In addition, the source of virus strains and cells for production is clear, the establishment of seed batch is reasonable and feasible; the production process and quality standard are feasible, the product quality can be controlled, and the stability of the product is good; after the product is put on the market, it is necessary to assist the Chinese Academy of inspection in the research of reference products This paper is organized by Daniel, research pharmacist Don't comment on some varieties.