[exclusive] analysis of the current situation of domestic listed drugs, short board and opportunities are here!

According to the database of drug intelligence drug screening system, there are 169816 drugs on the domestic market (calculated by approval number, the same below), including 165774 domestic drugs, 4042 imported drugs and 1641 imported drugs We can see that domestic drugs are the market leader, accounting for 97.62% of the total, while the proportion of imported drugs is relatively low However, it is these imported drugs that reflect the problems of large demand in the field of health, insufficient research and development, and the need for national research to speed up the pace of follow-up Fig 1 drug situation in domestic market Fig 2 classification of imported drug types in domestic market Fig 3 Classification of drug types in domestic market compared with Fig 2 and Fig 3, it can be seen that most drugs in domestic market are digestive tract and metabolic drugs, systemic anti infective drugs, respiratory system drugs, nervous system drugs, blood and hematopoietic system drugs However, most of the imported drugs are digestive tract and metabolic drugs, nervous system, anti-tumor and immune system regulating drugs, miscellaneous drugs, blood and hematopoietic system, and systemic anti infective drugs We can see that the market demand for digestive tract and metabolic drugs, nervous system, systemic anti infective drugs, blood and hematopoietic system drugs is very large, whether domestic or imported, while the domestic market share of anti-tumor drugs is relatively small, but it is only imported It can be seen that in terms of anti-tumor and immunomodulatory drugs, China's dependence on imported drugs will not be too short The analysis of the exclusive specifications, exclusive varieties and non-medical insurance only imported anti-tumor drugs in China is as follows: among the only imported anti-tumor drugs, the exclusive specifications and exclusive varieties that are large in the domestic market and expensive are not included in the medical insurance, which makes many national patients flinch As its production and agency company, it can be said that it monopolizes most of China's market and has a large profit These are all areas that need urgent adjustment of layout and focus of domestic enterprises Let's take a look at the situation of these drugs in China Fig 4 exclusive varieties, specifications and not included in the medical insurance only rely on imported anti-tumor drugs 1 Cetuximab injection Merck's cetuximab injection, trade name: ibital It can be used alone or in combination with irinotecan in the treatment of metastatic rectal cancer with over expression of epidermal growth factor (EGF) receptor and resistance to irinotecan based chemotherapy At present, only one company in China has applied for new drug imitation In clinical phase 1, there is still a long way to go to the market (as shown in Figure 5) According to the pharmaceutical intelligence data, the average price of cetuximab injection of 20 ml: 0.1g * 1 in 2017 was 4191.47 yuan At present, this specification has won the bid in 23 provinces and cities nationwide Fig 5 domestic R & D Progress of cetuximab injection 2 Paclitaxel for injection (albumin binding type) for injection (albumin binding type) was developed by albolis life science company of the United States, and imported by celgene corporation with the trade name of Abraxane ® and specification of 100mg Up to now, five domestic enterprises, namely, Zhengda Tianqing, Hunan Kelun, Qilu pharmaceutical, Jiangsu Hengrui, and Shiyao group, have submitted the registration application of paclitaxel for injection (albumin binding) class 1.6 new drug and class 3.4 new drug, and have obtained clinical approval documents successively According to the clinical database, the clinical trials of Jiangsu Hengrui and Shiyao group are still in phase 1 In addition, class 2.4 new drugs applied by Yangzijiang pharmaceutical are under review and approval Jiangsu Hengrui and Shiyao group have applied for the generic listing, which has obtained the qualification of priority review, and is still in progress At present, the average market price of 0.1g * 1 paclitaxel for injection (albumin binding type) is 5652.12 yuan, which has won the bid in 21 regions in China Figure 6 research and development progress of paclitaxel for injection (albumin binding type) in China 3 Patients with recurrent remitting multiple sclerosis and walking ability were treated with recombinant human interferon β - 1B for injection and recombinant human interferon β - 1B for injection of enasepril bringer Ingelheim Pharmaceutical Co., Ltd At present, there are only Bayer's import applications in China In the market, the recombinant human interferon β - 1B for injection imported from Bayer, Germany, with the specification of 30mg * 1, was included in the list of 36 national negotiation drugs, with an average price of 590 yuan in 2017, which was lower than the 826.5 yuan imported from bringer Ingelheim before, and this specification won the bid in 7 provinces and cities nationwide It is the same as inarcept for injection of bringer Ingelheim Pharmaceutical Co., Ltd., trade name: enri It is suitable for rheumatoid arthritis (RA) and ankylosing spondylitis (as) At present, there is only one clinical information registered in the clinical center, which is in clinical phase 1 The average price of 25mg * 1 etanercept for injection in 2017 is 2037.28 yuan, which has won the bid in 18 provinces and cities in China Fig 7 research and development progress of enacept for injection in China 4 Triptoreline dihydroxynaphthenate for injection is suitable for locally advanced or metastatic prostate cancer At present, only one company, Bofu Yipu Sheng, was approved for import in 2009, and applied for import of new indications in 15 years Now it has been approved for clinical use The clinic has entered three stages In 2017, the average price of 15mg * 1 on the market was 4786.49 yuan, winning the bid in 23 regions in China Fig 8 domestic R & D Progress of triptoreline dihydroxynaphthalenate for injection 5 The main component of arubicin hydrochloride for injection is arubicin hydrochloride of microbiopharmjapan Co., Ltd., and the indications for injection are acute leukemia, malignant lymphoma, and other solid malignant tumors At present, only Shenzhen Wanle Pharmaceutical Co., Ltd has been approved for import, while in the market, there are two companies, Shenzhen Wanle and Yangzhou Pharmaceutical Co., Ltd., producing arubicin hydrochloride for injection In 2017, the average market price of 20 mg * 1 adrobicin hydrochloride was 90.04 yuan This specification has won the bid in 30 provinces and cities in China, which shows that the domestic market is large Fig 9 domestic R & D Progress of arjubicin hydrochloride 6 Idadipicin hydrochloride capsule of nerpharma S.R.L (Italy) is suitable for acute non lymphocytic leukemia It is the first-line treatment for adult acute non lymphocytic leukemia and the treatment drug for relapsed or refractory acute non lymphocytic leukemia patients when they cannot be given idadipicin via vein At present, China's general strength of famasia has been approved for import, while Zhejiang Haizheng's generic drugs have been approved for clinical use In 2017, the average market price of idabixin hydrochloride capsule with the specification of 10mg * 1 was 2031.26 yuan, which was awarded in 9 regions in China Fig 10 domestic R & D Progress of idabixin hydrochloride capsule 7 Sorafenib toluenesulfonate tablets and regofinib tablets of Bayer were approved for import as early as 2008, and Bayer also applied for import in the following years The latest 16 years obtained clinical approval, and the import application in 17 years was listed as the priority review In addition, 13 domestic companies, including Jiangsu Haosen, Qilu pharmaceutical, Zhengda Tianqing, Shiyao group, Hunan Kelun, Jiangsu Jiayi, Chongqing Yaoyou, Chongqing Shenghua Xi, etc., have successively obtained clinical approval for their generic drug applications It is worth mentioning that the 3.4 categories of new drugs of Jiangsu Jiayi pharmaceutical have also obtained clinical approval Bayer's three indications of clinical trials have been carried out to the third stage The bioequivalence test of Chongqing Yaoyou has been completed In 2017, the 0.2g * 60 toluenesulfonic acid sorafenib tablet was included in 36 national negotiation drugs, with a price of 12180 yuan Sorafenib toluenesulfonate tablets won the bid in 26 provinces and cities Figure 11 domestic R & D Progress of toluenesulfonic acid sorafenib tablets In addition, Bayer's regofinib tablet was approved for import in March 2017, and its chemical 2.4 import application also obtained the qualification of priority review, which has been completed There are also 15 domestic enterprises that have successively arranged the application for class 3.1 new drugs of regofinib tablets Except that Xi'an shuangrun medicine has not been approved, other companies have successively obtained clinical approval Regofinib's global sales in 2016 were 275 million euros, and Bayer predicted that the annual peak sales of the drug would reach 1 billion US dollars At present, the domestic market data is not sufficient It is estimated that the growth of domestic market scale in recent years will keep pace with the rapid growth of sales in other listed countries and regions Due to its indications and outstanding performance of its products, it is expected that its performance in the Chinese market in the future will be better than that of sorafenib In 2016, the domestic market size of solafeni is about 900 million yuan Fig 12 domestic R & D Progress of regofinib 8 Verofinib, Roche's verofinib, was approved for import in March 2017 It is the world's first targeted new drug for the treatment of unresectable or metastatic melanoma with positive brafv600 mutation At present, there is no other enterprise layout in China The Chinese market is still in the exploratory period Fig 13 domestic R & D Progress of vemurfeni tablet 9 Azacytidine for injection is the first pyrimidine drug approved by FDA, which is mainly used for the treatment of myelodysplastic syndrome (MDS), acute myeloid leukemia, etc Azacytidine is a rare drug in Europe, America and Japan Azacytidine for injection was approved for import in May, 2017, which is a good news for patients in China At present, there are also import applications of Hangzhou tiger and India redI doctor company, which were reviewed successively in December In addition, Sichuan Huiyu Pharmaceutical Co., Ltd and Zhengda Tianqing Chemical Pharmaceutical Co., Ltd are under review, and 6 enterprises including Hangzhou Rongli Pharmaceutical Co., Ltd., Shenzhen Deshang Pharmaceutical Co., Ltd., Nanjing Huawei, Shanghai huilun Jiangsu Pharmaceutical Co., Ltd., Nanjing Shenghe Pharmaceutical Co., Ltd and Qilu Pharmaceutical Co., Ltd have successively obtained clinical approval for class 3.1 new drug applications Azacytidine for injection has a sales volume of 728 million US dollars in 2016, which has a large space in China Figure 14 domestic research and development progress of azacytidine for injection 10 Infliximab for injection was mainly imported from Janssen, Xi'an, and then centrocor B.V and JINGDING medicine also applied for import, all of which have obtained clinical approval In addition, the new drug application of Xi'an Janssen Pharmaceutical has also obtained clinical approval At present, there is no new drug application information of other enterprises except Xi'an Janssen In 2017, the average price of 0.1g * 1 infliximab for injection on the market was 5584.13 yuan At present, it has won the bid in 27 provinces and cities Figure 15 domestic R & D Progress of infliximab for injection 11 At present, AstraZeneca has obtained import approval in 2010, and another two import applications have been approved for clinical use At present, the clinical use of two new indications has entered phase 3 In addition, in 2017, the chemical medicine category 5.2 import application of Dr redI laboratory Co., Ltd of India is under review and approval The generic applications of Jiangsu Haosen and Zhengda Tianqing have also been reviewed At present, 5ml: 0.25g * 2 fluvastatin injection has been included in 36 national negotiation drugs, with the price set at 4800 yuan Figure 16 domestic R & D Progress of fluvistrane injection