Reform Dongfeng Zhengsheng, 2017 new drug R & D market

2017 is coming to an end, and I'm feeling that this year is really going by so fast Some pharmaceutical companies have quietly applied for several class 1 new drugs, some of them are old giants and some of them are black horses in the industry This paper focuses on the application of class 1 new drugs in 2017 (up to December 20, 2017) As of December 20, 2017, 456 new class 1 drugs (calculated by acceptance number) have been applied Among them, 383 applications for chemical drugs, 71 applications for biological products, and 2 applications for traditional Chinese medicine Chemical medicine accounted for nearly 84% There are 433 applications for clinical vs application for clinical listing, among which lcar-b38mcar-t cell autotransfusion preparation is the first car-t drug accepted in China Among the 23 declared for listing, the recombinant Ebola virus vaccine has been approved for listing, and Xindi mAb injection is the first domestic PD-1 mAb to apply for listing Lcar-b38mcar-t cell autotransfusion preparation was accepted by CDE on December 11 It is a car-t therapy targeting B cell mature antigen (BCMA) developed by Nanjing legend biology At present, there are two car-t drugs on the market in the world, kymriah of Novartis and yescarta of kite, which were approved by FDA in August and October this year respectively The recombinant Ebola virus vaccine was jointly developed by the Institute of bioengineering, Academy of Military Medical Sciences and kangxinuo biology Co., Ltd The death rate of Ebola virus is very high The World Health Organization lists it as one of the most serious diseases that do harm to human beings Due to the seriousness of the disease itself and the needs of public health, the review and approval process of the vaccine can be described as "open all the way" In February 2015, it obtained the clinical approval, and in May 2017, it was declared for listing In June 2017, it accepted the application for registration of innovative drugs and major special projects In the priority review, in October 2017, CFDA approved the new drug registration application Xindi mAb is developed by Xinda biopharmaceutical (Suzhou) Co., Ltd It is the second PD-1 / PD-L1 drug applied for listing in China by opdivo, a BMS company, for the treatment of Hodgkin's lymphoma At present, five PD-1 / PD-L1 drugs have been listed in the world In addition to Xinda biology, there are Hengrui, Junshi, Baiji Shenzhou and other enterprises in China to carry out R & D layout 383 domestic applications vs 73 import applications for class 1 new drugs There are 130 domestic and 25 foreign manufacturers involved Among the local enterprises, Jiangsu Hengrui Pharmaceutical Co., Ltd and Guangdong dongyangguang Pharmaceutical Co., Ltd have the largest number of applications, both of which are 20 Five manufacturers with the largest number of class 1 new drugs declared by foreign enterprises are all pharmaceutical giants, of which Novartis (China) biomedical research Co., Ltd has the largest number of applications, 9 Hengrui and dongyangguang, two well behaved domestic enterprises, apparently continue to exert their strength in research and development of anti-tumor drugs Eight of the 20 class 1 new drugs are anti-tumor drugs In addition to the unknown indications of hec68498, hec74647pa and ritapirun, dongyangguang Pharmaceutical Co., Ltd has two other anti hepatitis C drugs and anti Alzheimer's drugs Among the class 1 new drugs declared in 2017, in terms of treatment category, except those unable to confirm the treatment category, the number of anti-tumor drugs declared is the largest, followed by anti infective drugs and endocrine and metabolic regulation drugs Among the anti-tumor drugs, targeted small molecule drugs and monoclonal anti-tumor drugs are eye-catching, accounting for nearly half In 2017, it was favorable for drug research and development In particular, the opinions on deepening the reform of review and approval system and encouraging the innovation of medical devices issued in October had an unprecedented impact on improving the reform of drug review and approval system and encouraging drug innovation and research and development Although China's drug R & D is still facing many difficulties, the reform is driven by Dongfeng, hoping to bring more gratifying results.