600 billion market! 5 pharmaceutical companies such as Qilu, Kelun and Hengrui are the first

On January 21, Hengrui pharmaceutical was approved to produce temozolomide for injection according to 4 categories of generic drugs, which was deemed to have passed the consistency evaluation Although there is no official document to define the specific implementation time node for injection consistency evaluation, many enterprises have made arrangements in advance According to the data of mienei.com, up to now, 34 enterprises (by group, the same below) have made injection consistency evaluation and applied 157 product specifications (involving 67 varieties) Qilu, Hengrui, Zhengda pharmaceutical, Kelun and other enterprises are at the forefront What's the magic trick? Table 1: Top 10 enterprises applying for injection consistency evaluation (source: Med China drug evaluation database 2.0, the same below) On December 22, 2017, CDE issued technical requirements for conformity assessment of chemical generic drugs (injections) on the market (Draft for comments) Although it is only a "technical requirements" document, the specific implementation time node and scope are not clear, it indicates that the conformity assessment of injections has been included in the agenda and will be carried out soon! According to the data of minenet, in 2017, the terminal injection Market of public medical institutions in China was close to 600 billion yuan Before the injection consistency evaluation really came, many enterprises had taken the lead in layout As of January 16, 34 enterprises had conducted injection consistency evaluation and applied 157 product specifications (involving 67 varieties) Qilu Pharmaceutical Co., Ltd., Hengrui Pharmaceutical Co., Ltd., Zhengda Pharmaceutical Co., Ltd., hausen Pharmaceutical Co., Ltd and Kelun Pharmaceutical Co., Ltd all have more than 10 supplementary application acceptance numbers for injection consistency evaluation, of which Qilu pharmaceutical is far ahead in 32 acceptance numbers and 17 varieties Four major pharmaceutical enterprises overtake in the curve of "foreign report to domestic report" According to document No 106 of 2016 issued by the State Food and Drug Administration: "for generic drugs that have been approved for listing in the European Union, the United States and Japan, domestic drug manufacturers can apply for listing in accordance with the new registration classification of chemicals based on the relevant information of foreign registration and declaration, and after approval for listing, they will be deemed to have passed the conformity evaluation; they are produced and listed in the same production line in China and in the European Union The drugs approved for marketing in the United States and Japan are deemed to have passed the consistency evaluation " This makes it a practical path for domestic enterprises to report the domestic consistency evaluation after the declaration of Anda in the United States, and it is also true that more and more enterprises are taking practical actions along such a path "Enterprises that have exported chemical injection to the international mainstream market will first complete the consistency evaluation and gain market advantage." Xie Mufeng, deputy chief pharmacist of Shanghai food and Drug Inspection Institute, thinks that export enterprises have obtained regional and national certification in production technology and product quality, which lays a good foundation for consistency evaluation of their products Table 2: application for conformity assessment of Qilu pharmaceutical injection There are 32 acceptance numbers of Qilu pharmaceutical injection consistency evaluation, involving 17 varieties, of which 8 varieties have obtained anda numbers in the United States, and these 8 varieties are declared with the relevant information registered abroad, without the need for be test; in addition, palonosetron hydrochloride injection and other products have also obtained anda, which is expected to be reported to China in the future There are 9 acceptance numbers of injections declared according to 3 and 4 categories of generic drugs, involving 6 varieties, which are deemed to pass the conformity evaluation after being approved for production Table 3: application for consistency evaluation of Hengrui pharmaceutical injection There are 12 acceptance numbers of injection consistency evaluation, involving 9 varieties, among which 7 varieties have obtained anda numbers in the United States These 7 varieties are declared with the relevant information registered abroad, and no be test is needed; in addition, dextromethomidine hydrochloride injection, cetepimidine injection and other varieties have also obtained anda, which is expected to be reported to China in the future   There are 10 acceptance numbers of injections declared according to category 3 and 4 of generic drugs, involving 8 varieties, of which temozolomide for injection declared according to category 4 has been approved for production recently, and has been included in the catalogue of drugs listed in China at present, which is deemed to have passed the consistency evaluation According to the data of minenet, in 2017, the sales volume of temozolomide at the terminals of public medical institutions in China was 1.855 billion yuan, with the production in Hengrui No injection was marketed before the product was approved; paclitaxel for injection (albumin binding type) was declared according to 6 categories of generic drugs, but it was included in the catalogue of Chinese listed drugs after approved production, which was deemed to have passed the consistency evaluation Table 4: application of hausen pharmaceutical injection consistency evaluation There are 13 acceptance numbers of Haosen pharmaceutical injection consistency evaluation, involving 7 varieties, among which gemcitabine hydrochloride for injection and vinorelbine tartrate injection have obtained the Anda number in the United States, and they are declared with the relevant materials registered and declared abroad, without further be test; there is 1 acceptance number of injection declared according to Category 3 and 4 of generic drugs, involving 1 variety, which is deemed to be the same after being approved for production Through consistency evaluation Table 5: application for conformity assessment of Puli pharmaceutical injection There are 2 acceptance numbers for consistency evaluation of Puli pharmaceutical injection, involving 2 varieties All of them have obtained anda numbers in the United States and applied with the relevant information registered abroad without be test; Azithromycin for injection has successfully passed the consistency evaluation, becoming the first injection approved through the supplementary application for consistency evaluation In addition, levetiracetam injection, voriconazole for injection and other varieties have obtained the Anda number in the United States, which is expected to be reported to China in the future Voriconazole for injection has been listed according to four generic drugs, and it is deemed to pass the consistency evaluation after being approved for production Kelun Pharmaceutical Co., Ltd and the big infusion leader have full advantages According to the annual report data of Kelun Pharmaceutical Co., Ltd., in 2017, the company achieved an operating revenue of 11.435 billion yuan, a year-on-year increase of 33.49%, of which the sales revenue of infusion products reached 7.579 billion yuan, a year-on-year increase of 26.12%, and the proportion of infusion sector in the company's total operating revenue was 66.28% According to the technical requirements for consistency evaluation of injections issued by CDE, general infusion such as sodium chloride injection and glucose injection are not included in the scope of consistency evaluation in principle, but some other requirements may be made in terms of sterilization process, which means that several heavy-duty products of Kelun pharmaceutical industry do not need consistency evaluation According to the data of minenet, the sales of sodium chloride injection, glucose injection and glucose sodium chloride injection of Kelun pharmaceutical in the terminals of public medical institutions in China in 2017 were 3.564 billion yuan, 1.979 billion yuan and 734 million yuan respectively Table 6: application for injection consistency evaluation of Kelun Pharmaceutical Co., Ltd in addition to ordinary infusion, therapeutic infusion needs to be included in the consistency evaluation At present, there are 15 application acceptance numbers for injection consistency evaluation submitted by Kelun Pharmaceutical Co., Ltd and undertaken by CDE, involving 9 varieties Table 7: injections declared by Kelun pharmaceutical according to new category 3 and 4 There are 18 acceptance numbers of injections declared according to 3 and 4 categories of generic drugs, involving 11 varieties Aripiprazole long-acting muscle injection has been approved for clinical use, and there is no such product on the market in China At present, only the products of the original manufacturer are sold in China, such as Shugeng glucose sodium injection, palipipidone palmitate injection, disodium gadolinate injection, compound electrolyte injection (II) 。 Source: minenet database note: data statistics as of January 16