Huahai pharmaceutical industry is in a rage! 11 anda, 7 consistency evaluation varieties

Recently, Huahai pharmaceutical released the 2017 performance express The company's operating revenue was 5 billion yuan, an increase of 22% over the previous year, and the net profit attributable to the parent company was 630 million yuan, an increase of 26% over the previous year The performance slightly exceeded the market expectation On the one hand, it benefited from the rapid growth of overseas APIs and preparations business; on the other hand, domestic preparations enjoyed a number of policy dividends, which brought huge increase to the performance With the increase in the number of products exported to China and the acceleration of new drug research and development, the performance of Huahai pharmaceutical is expected to rise again none="shifuMouseDownPayStyle('shifu_t_050')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; width: 558px; text-align: center; box-sizing: border-box !im portant; word-wrap: break-word !im portant; ">   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> the export leader of" raw materials + preparations "and the rapid growth of Anda quantity Huahai pharmaceutical is one of the leading enterprises in the production of APIs with Chinese characteristics According to the 2017 semi annual report, the company's API export has covered 198 countries, covering five continents, with more than 430 customers and a market share of more than 60% The main products are cardio cerebrovascular, anti depression, anti-virus and so on On the basis of characteristic APIs, the company has formed a complete industrial chain of integration of intermediates, APIs and preparations, vigorously developed foreign generic pharmaceutical business, and realized the upgrading of APIs to preparations In terms of overseas product registration, 42 products of the company have obtained the Anda number, 25 of which have been listed in the United States and many of which are in the leading market position; 12 products have been approved for listing in 24 countries of the European Union Figure 1: number of andas approved by Huahai pharmaceutical in the United States from 2011 to 2017 (source: annual report of listed companies) According to the annual report data of Huahai pharmaceutical, the number of andas approved by the company in the United States is increasing year by year By 2017, the company has a blowout growth, and Huahai pharmaceutical has become an important supplier of the U.S generic pharmaceutical market Table 1: in 2017, the approved anda products (source: Official Website of Huahai pharmaceutical) of Huahai Pharmaceutical Co., Ltd in the United States According to the data on the official website of Huahai Pharmaceutical Co., Ltd., there were 11 anda products approved (including temporary approval) by the U.S FDA in 2017, four of which were controlled release preparations In January 2013, lamotrigine controlled-release tablets, the first sustained-release and controlled-release preparation of Huahai Pharmaceutical Co., Ltd., were listed in the United States After that, the company broke through the technical barriers of sustained-release dosage forms through technical upgrading, and a number of highly difficult preparations were approved, such as quidipine sustained-release tablets, doxycycline pellets, etc., marking that the company's sustained-release and controlled-release preparation technology has reached a new level, and more features are expected to emerge in the future First and high-end generic drugs   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> a number of policies have been implemented, and the domestic value of export products highlights Figure 2: domestic and foreign revenue of Huahai pharmaceutical industry in 2011-2016 (unit: 100 million yuan) (source: annual report of listed companies) The operating revenue of Huahai pharmaceutical industry is divided into two parts: foreign revenue and domestic revenue According to the annual report data, the proportion of domestic revenue to total revenue increases year by year, and the proportion of foreign revenue to total revenue decreases year by year It can be seen that the former revenue of Huahai pharmaceutical industry was mainly from overseas Now, with the adjustment of domestic consistency evaluation, priority evaluation and bidding procurement policies, the domestic price of overseas certified varieties of Huahai pharmaceutical industry is The proportion of domestic sales revenue has gradually increased Table 2: in 2017, among the first batch of products that passed the consistency evaluation published by CFDA (source: CFDA official website), Huahai pharmaceutical became the biggest winner with 7 varieties and 9 acceptance numbers Among the 7 varieties that have passed the consistency evaluation, 5 are cardiovascular system drugs and 2 are nervous system drugs, marking that the company's domestic preparations occupy a certain market in the field of nervous system and cardiovascular system Table 3: in 2017, products included in the priority review procedure of Huahai pharmaceutical industry (source: meed China drug review database 2.0) according to meed China drug review database 2.0 statistics, in 2017, a total of 7 varieties (2 APIs, 5 preparations) and 14 acceptance numbers of Huahai pharmaceutical industry were included in the priority review procedure, one of which has been approved for production Table 4: 2016 Huahai pharmaceutical chemical top 5 (unit: 100 million yuan) (source: minnei.com China public medical institutions terminal competition pattern) According to minenet data, in 2016, at the terminals of China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions), Huahai pharmaceutical had five chemical drug sales of more than 100 million yuan, namely, paroxetine, losartan, irbesartan hydrochlorothiazide, risperidone and Fosinopril Figure 3: 2016 China public medical institutions terminal paroxetine manufacturer pattern (source: minenet China public medical institutions terminal competition pattern) paroxetine is a selective 5-HT reuptake inhibitor, mainly used for the treatment of depression, 2017 version of national medical insurance class B to class A, 2012 version of basic drugs Huahai Pharmaceutical Co., Ltd produces 20 mg paroxetine tablets According to the data of minenet, in 2016, the sales volume of paroxetine at the terminals of public medical institutions in China was 900 million yuan Huahai Pharmaceutical Co., Ltd ranked first with 41.8% of the total sales volume, which has exceeded the original manufacturers Figure 4: 2016 China's public medical institutions terminal losartan manufacturer pattern (source: minenet China public medical institutions terminal competition pattern) losartan is a non peptide angiotension II receptor antagonist, mainly used for the treatment of primary hypertension, 2017 version of medical insurance class B Huahai pharmaceutical produces 50mg and 100mg losartan potassium tablets According to the data of mienei.com, in 2016, the sales volume of losartan terminal in China's public medical institutions was 1.9 billion yuan With good quality and sales, the original manufacturer, MSD, currently occupies 60% of the market share, and Huahai pharmaceutical industry ranks third with 11.49% Figure 5: Manufacturer pattern of irbesartan hydrochlorothiazide at the end of public medical institutions in China in 2016 (source: competition pattern at the end of China's public medical institutions in minenet) Irbesartan hydrochlorothiazide is a compound preparation, which is mainly used to treat patients who can't effectively control blood pressure with irbesartan alone or hydrochlorothiazide 2017 version of national medical insurance class B Huahai pharmaceutical produces irbesartan hydrochlorothiazide tablets of 75mg / 6.25mg, which are the exclusive specifications According to the data of mienei.com, in 2016, the sales volume of irbesartan hydrochlorothiazide, the terminal of public medical institutions in China, was close to 1.7 billion yuan Sanofi, the original manufacturer, accounted for 40.5% of the market, and Huahai pharmaceutical industry ranked third with 10.86% Figure 6: in 2016, the pattern of risperidone manufacturers in China's public medical institutions (source: minenet China's public medical institutions terminal competition pattern) risperidone is a selective monoaminergic antagonist, mainly used for the treatment of acute and chronic schizophrenia, 2009 version of national medical insurance class B, 2012 basic medicine Huahai Pharmaceutical Co., Ltd produces two specifications of risperidone tablets, i.e 1mg and 2mg, and only two enterprises, i.e Huahai Pharmaceutical Co., Ltd and Enhua Pharmaceutical Co., Ltd., produce the dispersive tablets, and 2mg of Huahai Pharmaceutical Co., Ltd is the exclusive specification According to the data of mienei.com, in 2016, the sales volume of risperidone in China's public medical institutions was 1.25 billion yuan, and Huahai pharmaceutical ranked the fifth with a proportion of 10% Figure 7: the manufacturer pattern of Fosinopril at the end of China's public medical institutions in 2016 (source: the competition pattern at the end of China's public medical institutions in minenet) Fosinopril is a new type of ACE inhibitor, which is mainly used for the treatment of mild, moderate and severe hypertension and heart failure The company produces 10mg fosinopril sodium tablets According to the data of mienei.com, in 2016, the sales volume of fosinopril, the terminal of public medical institutions in China, was 400 million yuan Squibb, the original research manufacturer, ranked first with 71.35%, followed by Huahai pharmaceutical with 28.58%   none="shifuMouseDownStyle('shifu_bus_002')" style="margin: 1em auto; padding: 0px; max-width: 100%; color: rgb(62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> multiple products under research and entering the field of Biomedical Innovation figure 8: R & D expenditure of Huahai pharmaceutical industry in 2011-2016 (unit: 100 million yuan) (source: annual report of listed companies) According to the annual report data, in recent years, Huahai pharmaceutical industry has continuously increased its R & D efforts The R & D investment has increased from 85 million yuan in 2011 to 364 million yuan in 2016 The proportion of R & D investment in total operating revenue has also increased from 4.63% in 2011 to 8.89% in 2016 Through independent R & D and foreign cooperation, the company has entered the field of biomedicine, successively established Huabo, huaaotai and Huahai biological companies, and built a complete biomedical industry chain integrating R & D, production and sales Since 2013, the company has cooperated with many enterprises such as oncologics in the United States, Dowager in Hangzhou, and eutilex in South Korea to distribute a variety of biological drugs such as monoclonal antibody analogues, ADC and immune checkpoint antibodies Table 5: some products under research of Huahai pharmaceutical and its subsidiaries (source: global drug R & D base of minenet) According to the global drug research and development database of minenet, the drugs under research of Huahai pharmaceutical and its subsidiaries, such as adamumab analogue, bevacizumab analogue, yl-0919, recombinant human vascular endothelial growth factor receptor antibody (VEGF) fusion protein ophthalmic injection, have entered the clinical stage, among which the Recombinant EGFR fusion protein ophthalmic injection is the Fc fusion protein independently developed by Huabo biology, a subsidiary of Huahai pharmaceutical Syntharin, targeting at VEGF, can specifically block VEGF mediated vascular leakage and neovascularization It is mainly used to treat wet age-related macular degeneration (wet AMD) Up to now, Huahai pharmaceutical has invested about 45.1 million yuan in research and development of the drug Data source: advanced database of minenet, annual report of listed companies