Growth trajectory of eight representative varieties of Indigenous Innovation Medicine

Recently, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical and medical devices (hereinafter referred to as the opinions) In the opinion, China's pharmaceutical innovation has been raised to a strategic height, indicating the direction for the layout of the pharmaceutical market Among them, the priority review of innovative drugs and other policy dividends have been strengthened and consolidated Strengthening patent protection, drug test data protection, innovative drugs and high-quality generic drugs that have passed the consistency evaluation can be timely adjusted into the medical insurance catalog and drug centralized bidding, which will provide a more favorable policy environment for innovative drug enterprises Local high-quality innovative drug enterprises will usher in the best era In 2006-2016, most of the drugs on the market in China were imitations, and there were few innovative drugs, especially chemical drugs 1.1 and biological drugs 1 From the perspective of the 13th five year plan of China's pharmaceutical industry, an innovation vision plan has been put forward at the national level In 2030, we will strive to achieve the goal of developing 30 new drugs and rank among the forefront of innovative countries In the past two years, China's medical policies have emerged frequently, and the implementation of the new policy will play a good leading role According to the prediction of professionals, since 2018, many varieties of innovative drugs of Hengrui, such as thiopefigeristine (19K), pyrrolidine, androtinib of Zhengda Tianqing, danorevir of Geli biology, furaquitini of Hutchison Whampoa, and ninofloxacin (injection) of Zhejiang medicine, will be approved, and the market of innovative drugs of local enterprises will continue to be activated It is expected that in 2018-2020, 15-20 independent innovative drugs will be approved at the rate of 4-6 each year The opinions issued by the two offices will gradually change the current pattern of generic drugs, and innovative drugs in the pharmaceutical industry will enter a period of rapid development Figure 1: the overall performance of local innovative drugs in recent years in the sample hospital market (unit: 10000 yuan): statistical data include magnesium ISO glycyrrhizin, ecitinib, bicyclic alcohol, Compaq, iprazole, apatinib, Ella mod, Ericy Bbu, Tor Vapta, etofloxacin, Pa Rami Vee, Sylo do Sin, sidapamine, morpholidazole, and sample hospital sales Independent innovative drugs such as butylphthalide, magnesium isoglycate, exetinib, bicyclol, conbercept, iprazole, apatinib, alamod, arixib, tovaptan, Antofloxacin, palamivir, siloxane, xidaban, morpholinidazole, etc., which have been listed on the market, perform well in the sample hospital market Among them, the varieties with larger market space and better competition pattern mainly include: butylphthalide, magnesium isoglycolate, exetinib, bicyclol, conbercept, eprazole, apatinib, etc Fig 2 the sales trend of local innovation medicine representative sample hospital market sales trend (unit: 10000 yuan): butylphthalide six years of high speed growth: Trade Name: the hospital of the 2016: sample hospital sales volume: 690 million yuan, an increase of 27.8% Butylphthalide soft capsule was approved by stone Pharmaceutical Group in 2005 Its trade name is "enpip" It is mainly suitable for the treatment of ischemic stroke In April 2010, sodium butylphthalide chloride injection was approved for production, and the successful listing of new dosage forms added vitality to the market In 2010, the project of "butylphthalide raw materials and soft capsules" won the second prize of national science and technology progress award At present, this product has become the key product of the group According to the data statistics of domestic sample hospitals, from 2005 to 2009, the market of butylphthalide has been in a depressed state, and the amount of butylphthalide used in domestic sample hospitals has been basically maintained at 2-6 million yuan, which has not exceeded the 10 million yuan level in five years From 2010 to 2016, the market of EBP sample hospital showed a rapid upward trend, with high growth for six consecutive years The sales volume increased from 1.59 million yuan in 2005 to 690 million yuan in 2016 Among them, the sales volume of butylphthalide capsule is 450 million yuan, and that of butylphthalide injection is 240 million yuan In 2010, the oral regular release formulation of butylphthalide entered the 2009 version of the national medical insurance catalogue and the successful listing of EBP injection type, which became a turning point in the market, and the sales performance of the product grew rapidly In 2017, butylphthalide injection entered the new medical insurance catalog, and the market expansion of enbip is expected to further speed up In recent years, the sales growth of butylphthalide is considerable Facing the huge market of stroke treatment in China, there is still a lot of room for development in the future Magnesium isoglycyrrhizate is on the market, namely the hot selling trade name: Tianqing Ganmei enterprise: the sales volume of sample hospital of Zhengda Tianqing in 2016 was 660 million yuan, with a year-on-year growth of 12.2% Magnesium isoglycyrrhizate was developed by Zhengda Tianqing pharmaceutical industry, and obtained CFDA production approval document in September 2005 The trade name is "Tianqing Ganmei", the dosage form is injection, and the specification is 10ml: 50m This product is a national first-class innovative drug, mainly suitable for the treatment of various liver diseases In November 2007, it won the gold medal of the 10th China Patent Award The successful development of isoglycyrrhizic acid magnesium is a milestone of Zhengda Tianqing pharmaceutical industry, which marks that it is in the forefront of the world in the research and development of glycyrrhizic acid products, and it has entered a new era of research and development According to the data statistics of domestic sample hospitals, the market of magnesium isoglycyrrhizate has been in a rapid development state from 2005 to 2016: in 2006, the sales volume of sample hospitals was 2.83 million yuan, in 2009, it exceeded 100 million yuan, and in 2016, it reached 660 million yuan Because of its clear clinical effect, rapid effect, small side effects and outstanding performance, the product became a hot market product in the year it was launched In 2009, isoglycyrrhizic acid magnesium injection was included in the national class B medical insurance catalog, limited to rescue, liver failure and work-related injury insurance; in 2017, it was limited to patients with liver failure or unable to take glycyrrhizic acid oral preparation in the national class B medical insurance catalog The market of this product has been growing rapidly since it joined the national medical insurance catalogue Ektinib broke the import monopoly trade name of TiNi: Kemena enterprise: sales volume of Beida pharmaceutical's sample hospital in 2016: 230 million yuan, a year-on-year increase of 12.1% Ektinib, developed by Beida pharmaceutical, belongs to EGFR tyrosine kinase inhibitor, which is used for the first-line treatment of non-small cell lung cancer In June 2011, it was approved by CFDA to go on the market, with the trade name of "Kemena" and the dosage form of 125mg tablet In 2016, ektinib won the first "national first prize for scientific and technological progress" in China's chemical pharmaceutical industry, which is the first domestic chemical synthetic drug to win the award since the founding of the people's Republic of China The drug undoubtedly plays an important role in the field of new drugs in China According to the data statistics of domestic sample hospitals, from the perspective of sales trend in 2011-2016, exetinib has shown a high growth trend for four consecutive years The sales volume of sample hospitals in 2011 was 4.84 million yuan, and that in 2016 was 230 million yuan Exetane has become a new bright spot in the domestic small molecule targeted drug market, gradually breaking the monopoly of imported drugs, and rapidly rising in the Tinian market In 2017, ektini was included in the new version of the national medical insurance catalog, and it is believed that it will exchange price for quantity in the market, and the health insurance dividend will gradually reflect There is a huge market space for small molecule targeted lung cancer drugs in China, and exetane has become a key product of Beida pharmaceutical industry Dicyclohol: the first anti hepatitis innovative drug dealer Name: baiseno enterprise: Beijing Xiehe Pharmaceutical Co., Ltd sales volume of sample hospitals in 2016: 200 million yuan, up 21.9% year on year Dicyclohol was developed by the Institute of pharmaceutical research, Chinese Academy of Medical Sciences and Beijing Xiehe pharmaceutical factory In September 2001, it obtained the production number, the trade name is "prisinol", the dosage form is tablet, the specification is 25mg and 50mg This product is the first innovative anti hepatitis drug with independent intellectual property rights in China Since 1988, bicyclol has obtained more than 10 national invention patents in the United States, Europe, Japan, South Korea, etc In 2009, the patentee of the patent was changed to Beijing Xiehe Pharmaceutical Co., Ltd at present, only one domestic enterprise of Beijing Xiehe Pharmaceutical Co., Ltd holds the production approval of bicyclol and its tablets In 2006, bicyclol won the second prize of national science and technology progress award According to the data statistics of domestic sample hospitals, the dicyclohydrin market has been in a stable development state from 2005 to 2009 In 2009, the drug entered the national class B medical insurance catalog In 2005, the sales volume of dicyclohol sample hospital was 17.24 million yuan, exceeded 100 million yuan in 2013 and 200 million yuan in 2016 Conbercept market is still in the growing period Trade name: Langmu enterprise: Kanghong pharmaceutical's sales volume of sample hospital in 2016: 130 million yuan, a year-on-year increase of 84.4% Developed by Chengdu Kanghong, conbercept was approved by CFDA for listing in 2013 The trade name is "Langmu" and the dosage form is injection The specification is 0.2ml (10mg / ml) The drug is a new generation of anti VEGF fusion protein, which can inhibit pathological angiogenesis and be used to treat wet age-related macular degeneration At the end of 2013, conbercept was listed as a national first-class innovative drug, which not only made outstanding performance in China, but also was regarded as the first international generic name of biological products with completely independent intellectual property rights in China Since its listing, Compaq CEP has attracted the attention of the industry After its listing, it has opened up the situation rapidly and the market has grown explosively According to the sales trend of domestic sample hospitals in 2014-2016, the product shows a high growth trend for three consecutive years In 2014, the sales volume of conbercept sample hospital was 19.26 million yuan, and in 2016, it reached 130 million yuan This product has become the fastest-growing single product of Kanghong pharmaceutical industry As the third ophthalmic monoclonal antibody in the world, conbercept is still in a growing stage in the Chinese market In addition, the cost of fundus injection is high, so it is difficult for patients to receive sustained treatment for a long time, and the market needs further cultivation In 2017, compassie received medical insurance support through negotiation In the future, it can improve patient penetration and continue to expand market share The growth potential of iprazole: Yilian enterprise: sales volume of sample hospitals of Lizhu group in 2016: 130 million yuan, a year-on-year increase of 42.2% Iprazole was developed by Lizhu group and approved by CFDA for listing in December 2007 The product name is "Yilian" The drug type is enteric coated tablets, with a specification of 5mg This product is a kind of strong ion pump inhibitor It is a kind of new drug independently innovated by Lizhu group It has applied for invention patents in China, the United States, the European Union, Australia, Japan, Canada and other countries, becoming a new profit growth point of Lizhu company In January 2016, the product won the second prize of 2015 National Science and technology progress award, and it is a heavyweight product in the field of digestive tract According to the data of sample hospitals, six proton pump inhibitor products have been listed in China, including lansoprazole, pantoprazole, omeprazole, esomeprazole, rabeprazole and eprazole, of which eprazole is the latest and exclusive product In 2009, the sales volume of eprazole sample hospital was 970000 yuan, and in 2016, it was 130 million yuan, up 42.2% year on year In recent years, the market of alprazole has exploded with considerable momentum At present, there are more and more kinds of drugs to treat peptic ulcer, among them, proton pump inhibitor is the most effective and effective one in clinic It is noteworthy that iprazole sodium injection has been included in the priority review process With eprazole enteric coated tablets entering 2017