2017 annual report of Sinochem

Source: insight database 2018-01-19 in recent two years, the frequent occurrence of policies in the pharmaceutical industry is bringing China's pharmaceutical (600056, stock bar) industry into a new stage of development with both opportunities and challenges According to statistics, the market scale of chemical drugs in 2016 was 753.5 billion yuan, and the overall market of chemical drugs in China will move forward to trillion yuan in 2017 In 2017 (up to now), CDE has undertaken 3696 chemical acceptance numbers; 191 chemical acceptance numbers have been approved for production, including 87 active ingredients, 124 pharmaceutical enterprises and 18 new drug varieties In this report, we will focus on data analysis, and restore the real chemical industry with data such as chemical drug declaration and listing Report contents and application of chemical drugs: listing of chemical drugs in Jiangsu and Shandong: blood system, nervous system and digestive tract: Shanghai Pharmaceutical Group and Zhengda Tianqing generic drugs: application and listing of pramipexole and tenofovir dipivoxil: Zhengda Tianqing and Hengrui pharmaceutical remarks: Statistics of this report comes from insight Database, statistics as of December 21, 2017 If you have any questions about the data statistics method, please contact me via wechat (yiyaoshujuku001) 1 Chemical drug application status from January 1, 2010 to today, CDE has accepted 45486 chemical drug application acceptance numbers, accounting for 54, 159) 83.98% of the application acceptance number The specific annual proportion is shown in the figure below: Source: insight database Under the influence of policies, the number of drug applications has shrunk dramatically in recent two years, but the number of chemical applications is still the most important part of drug applications According to the relationship between supply and demand in the market, it can also be judged that the chemical market is still in great demand and still dominates the whole drug market From the regional perspective, Jiangsu Province and Shandong Province are the main positions for the application and acceptance of chemical drugs, followed by Guangdong, Zhejiang, Beijing and Sichuan It is worth noting that these major declaration provinces are currently carrying out MAH system pilot provinces Photo source: insight database 2 Among the chemicals that have been approved for listing this year, 1189 drugs have been registered for the first time Insight database shows that the distribution of these drugs in the treatment field is shown in the figure below, which mainly focuses on blood system drugs, nervous system drugs and digestive tract drugs Photo source: insight database 3 Chemical companies According to the data of pharmaceutical companies included in insight, there are 8136 companies applying for chemical drugs (including the number of parent companies, subsidiaries and their subsidiaries in total) Shangyao group has the largest number of approval numbers for the listing of chemical drugs A total of 762 chemical drugs are allowed to be sold on the market Huarun pharmaceutical, Huarun Shuanghe (600062, Guba), China Pharmaceutical Group, Guangzhou Baiyun Mountain (600332, Guba), Fosun Pharmaceutical (600196, Guba), Harbin Pharmaceutical Group, etc are all well-known enterprises with relatively perfect product system in China The specific ranking is shown in the following figure: Note: the largest number of chemical products applied for listing by all subsidiaries of the company is Zhengda Tianqing, the "king of first imitation" Up to now, Zhengda Tianqing has completed the efficient R & D of 53 products, which is in the leading position in the same industry in China The following figure shows the corresponding treatment fields of Zhengda Tianqing's research and listed products: Note: one product may correspond to multiple treatment fields 4 The number of generic drugs declared for listing by CDE this year is the largest among the 3 and 4 generic drugs accepted by the companies, including pramipexole (14) and tenofovir ester (9) Pramipexole is a product of bringer, which is used to treat the signs and symptoms of adult idiopathic Parkinson's disease At present, only one product is on the market in China, and 35 are under research (10 are imported and 25 are made in China); tenofovir is a Gilead product, which is suitable for the combination of other antiretroviral drugs to treat HIV-1 infection and hepatitis B at present, there are 28 in China Home has obtained the listing approval number Photo source: insight database at present, China's pharmaceutical market is dominated by generic drugs, and the overall level is still at a low level of repeated replication, resulting in overcapacity Take dexamethasone, which has a large number of imitated enterprises, as many as 624 enterprises have obtained the approval number for listing, but there are still 8 enterprises in clinical trials The competition is so fierce Unless the company has strong marketing ability, there are not many opportunities in the market Photo source: in recent two years, insight database has seen frequent policies, and more and more support for independent innovative drugs How to deepen and implement the understanding of innovation is the ultimate topic that the entire chemical industry needs to answer Next, we will analyze the current application and listing of new chemical drugs from the Perspective of data 5 The time-consuming and large investment of applying new drugs for chemical drugs are still in the initial stage in China According to insight data statistics, the number of new chemical drug applications declined significantly in 2016, from thousands per year to 663 (including 554 new drugs declared according to the registration classification in 2007) This year's number of applications is still lower than the previous year's level The main reason is that on March 4, 2016, the new registration method for chemical drugs was promulgated, and the definition of new drugs is more strict Photo source: after the release of the new chemical registration management measures in 2016, the list of major enterprises applying for new drugs in insight database is as follows: Note: the number of major components of drugs is calculated according to the number of major components in the treatment field, such as other dosage forms of dexamethasone For example, ordinary tablets, injections, ophthalmic preparations, etc are regarded as the main component of dexamethasone The number of pharmaceutical companies with more than two active ingredients of new drugs accounts for 34.69% At present, there are more than 10 companies with two active ingredients, namely, Zhengda Tianqing and Hengrui Pharmaceutical (600276, stock bar), followed by the subsidiaries that they declare together Approval of new drug production since 2010, the number of approved acceptance numbers has shown a downward trend The approval of domestic new drugs is shown in the following figure: Source: insight database 2010 has been approved to produce a total of 6882 acceptance numbers of innovative chemical drugs, only 18 of which have been approved this year The corresponding drugs of these 18 acceptance numbers are shown in the table below: According to insight data, after the issuance of the new registration management measures, 272 acceptance numbers of new chemical drugs declared according to category 1 have been approved for clinical use, and there is no drug approved for production On the whole, in the chemical medicine market, the volume of domestic innovative drugs is relatively small, because of the large investment in new drug research and development, fewer enterprises with the strength of research and development, fewer new drugs research and development, fewer drugs entering the clinic, and fewer drugs approved for listing.