Interpretation of the first batch of catalogues of listed chemical drugs in China, 15 product regulations of 10 Chinese pharmaceutical companies including Hengrui, Qilu, Chipset, Hausen, and Livzon were shortlisted

On November 28, 2017, CDE issued a notice on Soliciting Opinions on the first batch of varieties included in the catalogue of Chinese listed chemicals Solicit opinions from the public, and the deadline for soliciting opinions is December 10, 2017 The biggest change this time is to add the word "Chemistry" and clarify the scope of the catalogue 01 historical review On September 4, 2017, CDE issued "notice on public solicitation of framework opinions on China's listed drug catalog", which basically established the scope and use guide of listed drug catalog, and also communicated to the society that CDE officially started the preparation of China's listed drug catalog; on September 29, CDE issued "notice on solicitation of framework opinions on China's listed drug catalog" The supplementary notice of "will be extended to October 10 02 analysis of varieties included Based on the framework of the catalogue of Chinese listed drugs released on September 4 and the analysis of the catalogue of reference preparations released by CFDA, the first batch of drugs is planned to include 120 varieties and 189 product specifications, which are mainly divided into four categories: (1) the original imported drugs (98 varieties and 156 product specifications) in the catalogue of reference preparations of generic drugs published by the General Administration; (2) the drugs approved according to the new registration classification (11 varieties and 20 product specifications) (3) class 1.1 new drugs (9 varieties, 11 specifications) approved according to the original registration classification; (4) other varieties (2 varieties, 2 specifications) According to the statistical analysis of the state of drug marketing and sales, 189 product regulations can be divided into two categories: 147 in the marketing and sales, accounting for 77.78%; 42 in suspension of production and sales, accounting for 22.22% Will the release of the catalogue of listed chemicals prompt enterprises to re produce and sell these drugs? According to the statistics of the approval time of drugs, the earliest drugs can be traced back to 1991, of which the most approved drugs in 2017 are mostly drugs classified according to the new registration Further statistics on the categories of drugs included in the list show that the majority of imported original research drugs are included in the list This is also consistent with the above classification This time, it focuses on the original imported drugs listed in the catalogue of reference preparations issued by the general administration But I believe there will be more innovative drugs in the next two and three batches Table 1: in terms of statistical dosage forms, all of them are oral solid preparations, of which tablets account for the highest proportion, reaching 76.7% It is worth mentioning that there are three injections (three specifications of two varieties) in this time, namely, moroxynidazole sodium chloride injection of Jiangsu Haosen Pharmaceutical Group Co., Ltd and pemetrexed disodium for injection of Sichuan Huiyu Pharmaceutical Co., Ltd (specifications of 100mg and 500mg) Exactly three injections are all from Chinese pharmaceutical companies, which also points out the direction for the consistency evaluation of injections Table 2: compared with the framework released on September 4, another highlight of this catalogue set is the addition of the code of anatomy therapeutics and chemical classification system (ATC code) Some varieties have not written specific ATC code, and some have multiple ATC codes As can be seen in the figure below, most of them are cardiovascular system and nervous system drugs, and then anti-tumor drugs 03 enterprise analysis: a total of 10 Chinese pharmaceutical enterprises were shortlisted in 15 product regulations, with Jiangsu Hengrui having the most product regulations, including 4 All varieties are basically innovative drugs, and most of them are exclusive As this time covered the original imported drugs in the catalogue of reference preparations issued by the State Administration, most foreign enterprises, including Pfizer, only Hengrui was shortlisted in the top 20 Table 3 Ranking of all enterprises