Export of preparations to the United States: a new focus; export volume of stone drugs increased by more than 90%

Source: medical economic daily march 22, 2018 In the context of a new round of economic restructuring and supply side reform, the pace of transformation and upgrading of China's pharmaceutical industry has been further accelerated Enterprises have gradually increased from raw materials and low-end preparations to high-end preparations, improved new drugs and innovative drugs More and more enterprises are looking to the international market, deepening China through increasing certification and overseas cooperation Internationalization process of preparations In 2017, China's import and export of Western pharmaceutical preparations reached US $20.6 billion, a year-on-year increase of 19.2% Among them, the export was US $3.456 billion, up 8.32% year on year; the import was US $17.157 billion, up 21.66% year on year The trade deficit was US $13.7 billion, an increase of 25.56% From the perspective of monthly data, the growth rate of import and export shows a steady upward trend, especially import growth From the perspective of export scale, the growth rate in the first half of the year was relatively small, basically the same as that in the same period of 2016, which may be related to the tension between China and South Korea in the first half of the year and the decline of payment capacity in some regions of the middle East and South America However, since June, the export scale of preparations has been climbing month by month, and in December, it reached the largest export in a single month of the year, with a year-on-year growth of 23.3% From the perspective of import, except for the slight decline in the month of July, the import of the whole year basically maintained a stable and rapid growth trend The reasons for the rapid growth of China's foreign trade in pharmaceutical preparations are as follows: first, the demand for generic drugs has increased due to the expiration of global pharmaceutical patents and the optimization of pharmaceutical expenditure in various countries; second, the price of international bulk commodities has increased gradually, and the ability to pay has improved; third, the market in Europe, America and Japan has gradually saturated, and global pharmaceutical enterprises have paid more attention to China, which has promoted the import From the internal point of view, the first is the low base in 2016; the second is the acceleration of enterprise transformation and upgrading; the third is the internationalization of China's drug regulatory system, and the effect of many policies and measures gradually appears; the fourth is the obvious trend of integration of Chinese and foreign medical resources Focus on processing trade export and warehousing entrepot trade import In 2017, China's general trade import and export of preparations reached US $10.2 billion, a year-on-year increase of 19.8%, accounting for half of the total trade volume of Western medicine preparations It is the most important trade mode of China's import and export of western medicine preparations, with stable overall performance The export of processing trade maintained a rapid growth trend, with a year-on-year growth of 48.8%, 40% higher than the overall export growth, accounting for 45% of China's total export of preparations Among them, the export of processing trade with imported materials is mainly foreign-funded enterprises in China, mainly AstraZeneca, MSD and Pfizer, accounting for 97%; while in the processing trade with imported materials, Chinese and foreign enterprises share equally, among which the export of local enterprises is mainly in the United States, Africa, the United Kingdom, Spain and other markets, while foreign investment is mainly concentrated in two enterprises, Nord and Sanofi Warehousing and entrepot trade plays an increasingly important role in the import of Western pharmaceutical preparations In 2017, the import of Western pharmaceutical preparations through warehousing and entrepot trade reached US $7.54 billion, a year-on-year increase of 25.7%, accounting for 44% of China's total import of Western pharmaceutical preparations Yongyu, Keyuan Xinhai and Shanghai Guoyao Waigaoqiao are the top three enterprises engaged in the warehousing and entrepot trade import of Western pharmaceutical preparations, accounting for 40% of the total, with an increase rate of more than 20% In 2017, there were 73 kinds of Western medicine preparations exported to China, with the export volume of hormones, penicillins and cephalosporins increasing by 25.4%, 7.8% and 14.6% respectively, and the prices of bulk drugs increased by 7.37%, 2.83% and 1% year on year respectively After the volume and price of hormone drugs fell in 2016, there was a recovery growth last year, with insulin drugs, corticosteroids and drugs containing growth hormone growing the most significantly After several years of low-speed growth, penicillin drugs achieved the first price rise last year, mainly exported to Africa, Southeast Asia and the Middle East The cephalosporins have got rid of the trend of continuous price decline In recent years, the volume and price of cephalosporins have increased for the first time, and the export growth of cephalosporins is mainly high-end, mainly exported to ASEAN, Japan, Germany, the United States, Italy, Pakistan, Nigeria, Egypt and other markets Affected by the sharp rise of vitamin APIs, the average export price of vitamin drugs increased by 7.8%, but the export volume decreased by 3.4% In contrast, affected by the continuous decline in the price of American generic drugs, the price of some high-end generic drugs exported to the United States in China has declined In addition to clarithromycin and amlodipine, the average export price of a series of high-value-added pharmaceutical products to the United States, including anti-tumor drugs, psychotropic drugs and lipid-lowering drugs, has declined Fierce competition and low prices, coupled with the fact that there are not many generic products listed in the United States by Chinese enterprises, limited negotiation ability, and a long way to go for commercialization Important regional grandstand EU: bilateral trade soared, and the export of local enterprises entered the fast track In 2017, the bilateral trade between China and the EU in Western pharmaceutical preparations increased by 25%, higher than the overall 6% Among them, China's export of Western pharmaceutical preparations to the European Union increased rapidly, with the export volume reaching 670 million US dollars, an increase of 53.5% year-on-year, 45 percentage points higher than the overall export growth; the import from the European Union reached 12.6 billion US dollars, an increase of 23.8% year-on-year, accounting for 73.4% of China's total import of Western pharmaceutical preparations From the market point of view, in 2017, China's exports to the EU were mainly concentrated in France, Denmark, the UK, Belgium, Germany and Spain, accounting for 80% of China's total exports of preparations to the EU, of which the exports to Denmark and Belgium were mainly from multinational enterprises in Huawei, while the exports to Britain, Germany and Spain were mainly from local enterprises Although multinational enterprises such as Novo Nordisk and AstraZeneca have contributed a large share to the export of preparations to the EU, the export of preparations to the EU by domestic enterprises has also entered a period of rapid growth, especially the growth of agent processing business Among the top 20 enterprises exported to the European Union, 14 are Chinese enterprises, 11 are local enterprises with an export volume of more than US $5 million, and the exports to the European Union of Shenzhen Tiandao, Huahai, Shenzhen Lijian, Guilin Nanyao, Shenzhen Zhijun, Shandong Xinhua and other enterprises have achieved significant growth Germany, France, Italy, Sweden and the United Kingdom are the main import sources of preparations in China, accounting for 60% of the total amount of preparations imported In addition to a slight increase of 8% in imports from Italy, imports from other markets have achieved a substantial increase of more than 20% Influenced by the expansion of the domestic market and the implementation of the two vote system, some major import agents, such as Yongyu pharmaceutical, Keyuan Xinhai, Sinopharm holding, international pharmaceutical distribution center of the comprehensive insurance zone (Beijing), Shanghai Waigaoqiao, Shenzhen kangzhe, etc., have also achieved significant growth The United States: the Anda number has reached a new high, and the export growth of some enterprises has exceeded 20% The U.S market is large, the security mechanism is relatively complete, and the per capita income and reimbursement are relatively high, making it a large number of enterprises in China Some enterprises with strong cost control ability, good hardware and software foundation and capital strength have started to register and apply for new drugs and generic drugs in the United States   In 2017, Chinese enterprises were approved 34 anda numbers in the United States, a record high No matter Huahai pharmaceutical, humanwell, Haizheng and other pharmaceutical enterprises with international expertise, or Hengrui, Shiyao, Qilu and other enterprises with rapid development in recent years, they are scrambling to accumulate anda numbers when entering the U.S market, and some enterprises dominated by the domestic market and emerging market are also beginning to pay attention Aiming at the U.S market, Huaren pharmaceutical, Shiqiao biology, Ruiyang pharmaceutical and Changbu pharmaceutical have also made breakthroughs, achieving the first anda approval in the United States In 2017, China's export of Western pharmaceutical preparations to the United States reached US $310 million, an increase of 5.4% year-on-year, accounting for 9% of China's total export of Western pharmaceutical preparations Local enterprises have become the main driving force for export to the United States Among the top 10 export enterprises to the United States, 9 are domestic enterprises, with the export growth rate of Huahai, Nantong Lianya, Renfu, Qilu, Shiyao, etc over 20% Nine products of Qilu pharmaceutical have been exported to the United States, with the export volume exceeding US $8 million In 2017, eight anda numbers of petrochemicals were approved, and the export volume to the United States exceeded US $6 million, with a year-on-year increase of more than 90% In addition, although the export volume of Jiangsu Haosen, Beijing SECCO, Shandong Xinhua, etc is not large, the export to the United States also made some breakthroughs in 2017 Africa, "one belt, one road": the export growth area is high, the multi regional growth rate exceeds 20% in 2017, China's export to Africa was US $520 million, up 11.2% over the same period last year, higher than the 2.9 of the total preparations export Nigeria, democratic Congo, Tanzania and Cameroon are the top four markets in China's pharmaceutical exports to Africa, accounting for nearly 40% of China's total pharmaceutical exports to Africa, with year-on-year growth of 24%, 43%, 52% and 27% respectively With the recovery of commodity prices denominated in US dollars, exports to Angola, South Africa and Algeria also rebounded significantly, with year-on-year growth of 24.9%, 5.8% and 107%, respectively In terms of export products, at present, the export products to Africa are still concentrated in antimalarial drugs, antibiotics, anti infective and analgesic drugs China's foreign trade one belt, one road along the other side has increased rapidly, and the export has increased rapidly to 53%, 31%, 19.4% and 23% respectively India, Pakistan, one belt, one road, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, one country, and the other is the five countries The five main countries, namely, the Malaysia, Poland, Burma, Russia, Bangladesh, Ukraine and Central Asia, are the main force to stimulate the growth of Western medicine preparations and the key markets for the export of Chinese medicine preparations Among them, one belt, one road, the other two, China has achieved more than 20% growth in India, Pakistan, Bangladesh, Russia and Ukraine, and has achieved three digit growth in Poland's exports The exports to India, Philippines, Pakistan, Thailand and Malaysia are over 70 million dollars, and become the five largest markets for the export of Western medicines to the "one belt and one road" export There are more and more Chinese pharmaceutical companies which are deeply involved in the international market In recent years, the internationalization of Chinese preparations has witnessed a rapid growth, with more than 300 local enterprises in the field of internationalization of preparations 1 Profitability: the way of internationalization of preparations for many enterprises is just starting, and mainly in emerging markets Although there are more and more enterprises entering the high-end market such as the United States, there is a serious imbalance between input and output, and there is still a long way to go to improve the profitability of pharmaceutical exports At present, China's pharmaceutical enterprises have obtained more than 150 anda numbers in the United States, but only about 60 have achieved commercialization, mainly focusing on large pharmaceutical enterprises such as Huahai, Hengrui, Renfu, Nantong Lianya, Qilu and Shiyao, and the internationalization started earlier 2 First imitation Application & 3 Patent challenge It is worth mentioning that the first imitation application and patent challenge of Chinese pharmaceutical products in the United States have made a historic breakthrough, the first imitation of Hengrui cyclophosphamide and desflurane for inhalation has been approved in the United States, and the patent challenge of paloxetine of Huahai pharmaceutical industry has been successful, which has effectively improved the confidence of pharmaceutical enterprises in the internationalization of preparations in China 4 Overtaking in curve with the full opening of consistency evaluation, and China