82 injection reference preparations exposed 23 varieties were "looted"

Yesterday (June 3), CDE released the 22nd batch of generic reference preparations catalogue, involving 495 drugs, 231 of which belong to injection / injection, involving 82 varieties (by drug name) According to the data of mienei.com, 64 of the 82 varieties have been evaluated for the consistency of enterprise layout (including supplementary application for consistency evaluation and application for new registration and classification), among which 23 varieties have been declared by more than 2 enterprises (including 2), 18 varieties have not been declared by enterprises for the time being, including many large varieties with sales of over 100 million; from the perspective of enterprise declaration, Kelun pharmaceutical leads the way in applying for 9 varieties 82 injections published reference preparations, 64 existing enterprises layout table 1: development of injection consistency evaluation of published reference preparations note: the same active ingredient is regarded as different varieties according to different acid roots, ions, etc (source: CDE official website, minenet database) Of the 82 injections for which reference preparations have been published, 64 varieties of which have already been submitted by enterprises according to the supplementary application for conformity assessment or according to the new registration classification (generic drugs category 3, 4 and imported 5.2), the former passed the conformity assessment after approval, and the latter passed the conformity assessment after approval of production Figure 1: enterprises applying for more than 5 varieties (including 5) (source: CDE official website and minenet database) from the perspective of enterprise application, 64 varieties involve 57 pharmaceutical enterprises (by group), and enterprises applying for more than 5 varieties include Kelun pharmaceutical, Qilu pharmaceutical, Yangzijiang pharmaceutical and Zhengda pharmaceutical, among which Kelun pharmaceutical takes the lead in applying for 9 varieties According to midnet Med China drug review database 2.0, among the enterprises applying for injection conformity assessment (including supplementary application for conformity assessment and new registration classification application), Kelun pharmaceutical is far ahead in 35 varieties According to the evaluation results, only one product has passed or deemed to pass the consistency evaluation, which is ketorolac aminobutyritol injection of Chengdu Beite Pharmaceutical Co., Ltd the product is listed in three categories of generic drugs and deemed to pass the consistency evaluation after being approved for production Figure 2: Sales of ketorolac and aminobutanol injection in public hospitals of key provinces and cities from 2013 to 2018 (unit: 10000 yuan) (source: terminal competition pattern of public hospitals in key provinces and cities of mienei.com) According to the data of mienei.com, in recent years, the sales volume of ketorolac tromethamine injection in the public hospital terminals of key provinces and cities has been increasing year by year, with an average annual growth rate of double digits In 2018, it broke through 100 million yuan for the first time, an increase of 60.35% over the previous year At present, there are three pharmaceutical companies in the domestic market with the production approval documents of ketorolac and ambuterol injection, and Chengdu Beite Pharmaceutical Co., Ltd is the first one to have been evaluated by the application way of new registration classification 23 varieties were "looted" and 9 enterprises declared exceeded 3 table 2: varieties with more than 3 (including 3) enterprises declared out of 64 varieties (source: minenet database) Of the 64 varieties, 41 varieties were exclusively declared, 14 varieties were declared by 2 enterprises, 9 varieties were declared by more than 3 enterprises (including 3 enterprises), and 18 varieties were temporarily not assessed for the consistency of enterprise layout From the perspective of competition pattern, the largest number of enterprises layout the concentrated solution for injection of levetiracetam According to the data of mienei.com, in 2018, the sales volume of levetiracetam, the terminal of public hospitals in key provinces and cities, was 355 million yuan, of which the injection accounted for only 0.07% of the market share At present, only the original research factory, jiayoushibi, is listed in the domestic market to sell the concentrated solution for injection of levetiracetam, Puli pharmaceutical, Beite pharmaceutical, etc The products of the enterprise shall be submitted for listing according to the new registration classification, and shall be deemed to have passed the conformity evaluation after being approved for production Figure 3: brand pattern of omeprazole sodium for injection in public hospitals of key provinces and cities in 2018 (source: terminal competition pattern of public hospitals in key provinces and cities of mienei.com) The sales volume of omeprazole sodium for injection in public hospitals in key provinces and cities in 2018 is close to 1 billion yuan At present, there are 105 manufacturers with production approval documents in the domestic market From the perspective of competition pattern, Jiangsu aosaikang Pharmaceutical Co., Ltd ranks first with 39.5% market share Up to now, only three pharmaceutical enterprises, i.e Poinsettia pharmaceutical, aosaikang pharmaceutical and Shandong new era pharmaceutical, have submitted supplementary application for conformity assessment, and no enterprise has submitted listing application according to the new registration classification 18 injections were "cold", 5 were over 100 million varieties Table 3: 64 varieties that did not have the enterprise layout consistency evaluation temporarily (source: minenet database) 18 of the 64 varieties have not yet been evaluated for the consistency of enterprise layout According to the data of mienei.com, 5 of the 18 varieties had terminal sales of more than 100 million yuan in public hospitals of key provinces and cities in 2018, and alanyl glutamine injection led the way with sales of 555 million yuan Figure 4: Sales of alanyl glutamine injection in public hospitals of key provinces and cities from 2013 to 2018 (unit: 10000 yuan) (source: terminal competition pattern of public hospitals in key provinces and cities of mienei.com) At present, alanyl glutamine injection sold on the domestic market includes alanyl glutamine for injection and alanyl glutamine injection, of which alanyl glutamine injection accounts for 78% of the market share In recent years, according to the sales situation of public hospitals in key provinces and cities, the overall sales volume of alanyl glutamine injection has declined, and the decline rate has increased year by year The sales volume is low, but there are many competitive manufacturers, the sales volume continuously declines and the decline rate increases year by year, and the approved production enterprises are few Maybe these are the reasons why the above injection varieties have not yet been evaluated for the consistency of enterprise layout, but there are some exceptions, such as doxorubicin hydrochloride liposome injection Figure 5: Sales of doxorubicin injection in public hospitals of key provinces and cities from 2013 to 2018 (unit: 10000 yuan) (source: terminal competition pattern of public hospitals in key provinces and cities of mienei.com) In recent years, sales of doxorubicin injection in public hospitals of key provinces and cities have increased year by year, with high annual growth rate and good growth potential At present, doxorubicin hydrochloride liposome injection and doxorubicin hydrochloride for injection are sold on the domestic market Doxorubicin hydrochloride liposome injection accounts for 99% of the market share, and three enterprises, i.e Ouyi Pharmaceutical Co., Ltd., Zhangjiang biomedical Co., Ltd of Shanghai Fudan, and Jinyuan Pharmaceutical Co., Ltd of Changzhou, have the production approval documents of the product, but the consistency evaluation has not been started yet Note: data statistics as of June 3, if there is any omission, please correct it! The sample of chemical pattern of public hospitals in key provinces and cities of mienei.com covers 20 + provinces and cities (Beijing, Inner Mongolia Autonomous Region, Heilongjiang Province, Jilin Province, Liaoning Province, Tianjin city, Hebei Province, Guangdong Province, Henan Province, Chongqing City, Hubei Province, Hunan Province, Shanghai City, Shandong Province, Anhui Province, Zhejiang Province, Jiangsu Province Sichuan Province, Shaanxi Province, Yunnan Province, Xinjiang Uygur Autonomous Region, etc.)