Viewing the status quo of antidepressant research and development from the application and approval data

With the improvement of people's life quality, people begin to pay attention to their spiritual world Depression is also slowly coming into people's vision In February this year, the World Health Organization released the report on depression and other mental diseases, which shows that there are 322 million people suffering from depression in the world, accounting for 4.4% of the global population From the perspective of countries, depression cases account for more than 5.5% of the national population in the United States, Australia, Brazil, etc., while Ukraine accounts for more than 6% and China for 4.2% According to the latest data from the National Bureau of statistics, China's population at the end of 2015 was 13746.21 million, so it is estimated that the number of people suffering from depression in China has exceeded 57.73404 million With the increasing number of depression, the society calls for attention to depression, calls for the country to issue corresponding protection policies one after another, the quality and diversity of antidepressants are also increasingly demanding So what is the current situation of research and development of antidepressants in China? Let's have a look According to the database of registration and acceptance of intelligent drugs in China, 1565 entries have been registered and accepted in 17 years since 2000 (as of November 20, the same below) Among the types of antidepressants registered, there are 829 new drugs, accounting for 52.97% (see Figure 1 for details) Among the new drugs, only Zhejiang Huahai and Shandong green leaves declared the drug of 1.1, and the drug has been listed in the special approval and major special drugs Figure 1 types of antidepressant registration and application (by acceptance number, unit: article) In drug classification, it is obvious that chemical drugs are the main force, with 1517 application records in total, and only 41 application records are supplemented by traditional Chinese medicine (see Figure 2 for details) Figure 2 classification of antidepressants registered and declared drugs (by acceptance number, unit: article) From 2000 to 2017, the number of antidepressant registration applications fluctuated greatly In 2005, 2006, 2014 and 2015, there was a peak period of application With the implementation of generic drug consistency evaluation and the introduction of a series of pharmaceutical innovation incentive policies, the number of applications decreased sharply in 2016, reaching a new low this year As of November 20, the number of applications in 2017 was only 36, and there was no new drug application this year The shadow of the newspaper Figure 3 Number of antidepressants registered and declared in 2000-2017 (by acceptance number, unit: article) main varieties in domestic market According to the application varieties in the registration and acceptance database of smart drugs, we searched the domestic drug database, and found that 24 varieties (see Figure 4 for the top 10 varieties in the number of approved documents) have obtained the approval at present (see Figure 4 for the top 10 varieties in the number of approved documents), and it can also be seen that there are not many varieties of antidepressants in the market at present In terms of drug dosage form, tablet is the main form, injection and oral solution are also available, but less Figure 4 the top 10 varieties (calculated by approval number, unit: article) in terms of inclusion in the medical insurance, except that bupropion is only included in the medical insurance in Hubei, Qinghai and Henan provinces, and not included in the national medical insurance, the other 9 varieties are included in the medical insurance in more than 29 regions, and all of them are included in the national medical insurance (see Figure 5 for details) it is worth mentioning that doxepin hydrochloride tablets and clomipramine hydrochloride tablets are included in the varieties that must complete the consistency evaluation before 2018 According to the latest information of CFDA, there are 13 enterprises that hold the document number of doxepin hydrochloride tablets, 6 enterprises that do not give up the evaluation, 7 enterprises that give up, 5 enterprises that have carried out relevant work; 5 enterprises that hold the document number of clomipramine hydrochloride tablets, 3 enterprises that do not give up the evaluation, 2 enterprises that give up, 2 enterprises that have carried out relevant work Figure 5 Statistics of drugs included in medical insurance (by number of regions, unit: No.) in addition to the above 10 varieties with more approvals, most of the other listed varieties are also included in medical insurance by the state and most regions, and agomeladine and minapram are the new varieties of national medical insurance in 2017 (see Figure 6 for details) Figure 6 statistics of drugs included in medical insurance (calculated by the number of regions, unit: four potential varieties) From the perspective of CDE acceptance quantity, duloxetine, venlafaxine, sertraline and other varieties are more popular among enterprises Compared with their approval documents, we can find that duloxetine, paroxetine, agomeladine and wotexitin have more acceptance quantity, but the number of approval documents is less (see Figure 7 for details), which is definitely the Highland for enterprises to compete in the future Figure 7 Comparison of acceptance quantity and approval quantity (by acceptance / approval number, unit: article) according to the Research Report of Guangfa Securities, duloxetine is the antidepressant "heavy bomb" drug listed by Lilly in 2004, with global sales of more than 5 billion US dollars in 2012, and the US patent expired on June 11, 2013 After the expiration of the patent, a large number of generic drugs poured in At present, there are 177 records of applying for the product in China However, only 5 duloxetine related products are listed according to the domestic drug database of pharma intelligence Among them, duloxetine hydrochloride enteric coated tablets produced by Jiangsu Enhua, duloxetine hydrochloride enteric coated tablets and duloxetine hydrochloride enteric coated capsules produced by Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd are included in class B of medical insurance (see Figure 8 for details) Figure 8 Paroxetine is the largest antidepressant in China, with an annual sales volume of more than 1 billion yuan At the same time, it is the only antidepressant among the 36 varieties successfully negotiated in the second round of medical insurance drug negotiations in 2017 The newly added antidepressant is paroxetine hydrochloride enteric coated sustained-release tablets imported by GlaxoSmithKline (China) Investment Co., Ltd In addition, 7 products of 4 domestic enterprises have been listed (see Figure 9 for details) Figure 9 Compared with duloxetine and paroxetine, the number of approvals for agomelatin and wottixetine were less According to the domestic drug database of pharmaceutical intelligence, only agomeladine tablets produced by Jiangsu Haosen have been listed (see Figure 10 for details), and are included in the 2017 version of national medical insurance class B, and also included in the medical insurance class B of Gansu and Qinghai provinces Up to now, there is no approval information of vortexitin However, the imported vortexitin hydrobromide tablets declared by Lingbei (Beijing) Pharmaceutical Co., Ltd have been included in the fourteenth batch of drug registration applications under the priority review procedure, and are expected to be the first to be approved