New Aspects of Preparations Exported to the United States | Exports of Stone Drugs Increased by Over 90%...

In the context of a new round of economic restructuring and supply-side reform, the pharmaceutical industry has further accelerated the pace of transformation and upgrading of the pharmaceutical industry in China. The company gradually moves from raw material medicines, low-end preparations to high-end preparations, improved new drugs and innovations. As the pharmaceutical industry has grown, more and more companies have turned their attention to the international market and deepened the process of internationalization of Chinese pharmaceutical preparations by increasing certification and overseas cooperation.

In 2017, the import and export volume of western medicines in China reached US$20.6 billion, an increase of 19.2% year-on-year, of which exports were US$3.456 billion, an increase of 8.32% year-on-year; imports were US$17.157 billion, an increase of 21.66% year-on-year. The trade deficit was 13.7 billion US dollars, expanding 25.56%.

From the monthly data, the growth rate of imports and exports showed a steady upward trend. The growth of import growth was particularly noticeable. From the perspective of export volume, the growth rate in the first half of the year was relatively small, basically the same as in the same period of 2016, which may be in tension with the Sino-Korean relations in the first half of the year. It is related to the decline of payment capacity in the Middle East and parts of South America. However, since June, the export volume of pharmaceutical preparations has increased month by month, and it has reached the maximum value of single-month exports in December, an increase of 23.3% year-on-year. From the import point of view, except July With a slight drop in imports this month, the trend of stable and rapid growth remained basically throughout the year.

The reasons for the rapid growth of China's foreign trade in preparations are: externally, first, global drug Patent expires and countries medicine Expenditure optimization has increased the demand for generic drugs; Second, international commodity prices have gradually increased, and their capacity to pay has increased; Third, markets in Europe, America, and Japan have gradually become saturated, and global pharmaceutical companies have increased their attention to China and have driven the formation of imports. Viewed from the inside, This is a low base in 2016. Second, the pace of corporate transformation and upgrading is accelerating. Third, China's drug regulatory system is increasingly internationalized, and the effects of many policies and measures have gradually emerged. Fourth, the integration of Chinese and foreign pharmaceutical resources has a clear trend.

In 2017, the import and export of pharmaceutical preparations in China accounted for 10.2 billion U.S. dollars, a year-on-year increase of 19.8%, accounting for half of the total trade volume of western pharmaceutical preparations. It was the most important trade mode for the import and export of western medicine preparations in China, and its overall performance was stable. Processing trade exports maintained rapid growth. , an increase of 48.8% over the same period of last year, higher than the overall export growth of 40 percentage points, accounting for 45% of China's total exports of pharmaceutical preparations. Of which, the processing trade exports are mainly foreign-funded enterprises in China, mainly AstraZeneca, Merck and Pfizer, Accounting for 97%; while in the processing trade for imports, Chinese and foreign companies are equally divided, among which local enterprises export mainly to the United States, Africa, the United Kingdom, and Spain, and foreign capital mainly to Novo Nordisk and Sanofi. enterprise.

Warehousing and re-export trade has occupied an increasingly important position in the import of western medicine preparations in China. In 2017, Western medicines imported through warehousing re-export trades reached US$7.54 billion, an increase of 25.7% year-on-year, accounting for 44% of the total imports of Western medicine preparations in China. , Keyuan Xinhai and Shanghai Sinopharm Waigaoqiao are the top three companies engaged in the import and re-export of western medicine preparations, accounting for as high as 40%, and the increase rate is more than 20%.

In 2017, a total of 73 kinds of western medicines were exported to China. The export volume of hormones, penicillins, and cephalosporins increased by 25.4%, 7.8%, and 14.6%, respectively, and the prices increased by 7.37%, 2.83%, and 1% year-on-year, respectively.

Hormone drugs have experienced recovering growth last year after undergoing volume and price declines in 2016. Among them, insulin drugs, corticosteroids, and growth hormone-containing drugs have seen the most significant increase. Penicillins have experienced slow growth over the past few years. For the first time last year, volume and price rose, mainly exported to Africa, Southeast Asia, and several regions in the Middle East. Cephalosporins have been able to continue their downward trend in prices. In recent years, prices and prices have risen for the first time, and exports of more advanced cephalosporins have grown. Mainly exported to ASEAN, Japan, Germany, the United States, Italy, Pakistan, Nigeria, Egypt and other markets. Affected by the substantial increase of vitamins, the average price of vitamins has achieved a 7.8% growth, but the export volume However, it dropped by 3.4%.

In contrast, due to the continued decline in the prices of generic drugs in the United States, prices of some high-end generic drugs exported to the United States have shown a tendency to decline, including a few drugs such as clarithromycin and amlodipine, including anti-cancer drugs. The prices of a series of high-value-added preparations including psychotropic drugs and hypolipidemic agents have decreased in terms of average export prices in the United States. Intense competition and low prices, coupled with the limited number of generic pharmaceutical products listed by Chinese companies in the United States, have negotiated With limited capabilities, the road to commercialization has a long way to go.

EU: Bilateral trade soars, export of domestic companies enters the fast track

In 2017, bilateral trade between China and the European Union’s western medicines increased by 25%, which was higher than the overall rate of 6 percentage points. Among them, China’s exports to the EU’s western medicines increased rapidly, with exports reaching US$670 million, an increase of 53.5% year-on-year, which is higher than the overall export growth rate. 45 percentage points higher; imports from the EU 12.6 billion US dollars, an increase of 23.8%, accounting for 73.4% of China's total imports of western medicine preparations.

From the market point of view, in 2017, China’s exports to the EU were mainly concentrated in France, Denmark, the United Kingdom, Belgium, Germany and Spain. It accounted for 80% of China’s total exports of pharmaceutical preparations to the EU. Among them, exports to Denmark and Belgium were transnational. Enterprises are mainly located in China, while exports to the United Kingdom, Germany, and Spain are mainly local companies.

Although Novo Nordisk, AstraZeneca and other multinational corporations have contributed a large share of China's formulation exports to the European Union, China’s domestic enterprises have also entered a period of rapid growth in exports to the European Union. In particular, the substitution processing business has grown rapidly. Exports to the EU Among the top 20 companies, there are 14 local Chinese companies, 11 local companies with exports exceeding 5 million U.S. dollars, Shenzhen Tiandao, Huahai, Shenzhen Lijian, Guilin Nanyao, Shenzhen Zhijun, Shandong Xinhua and other European Union exports. Both have achieved substantial growth.

Germany, France, Italy, Sweden and the United Kingdom accounted for 60% of the total imports of preparations in China, the most important source of imports for pharmaceutical preparations in China, and imports from other markets achieved more than 20% in addition to a slight increase of 8% from Italian imports. The substantial increase. Due to the expansion of the domestic market and the implementation of the two-vote system, some major imports proxy Business Yongyu Pharmaceutical, Keyuan Xinhai, Sinopharm Holdings, Shuangpu District (Beijing) International Pharmaceutical Distribution Center, Shanghai Waigaoqiao, Shenzhen Kangzhe and other imports have also achieved substantial growth.

US: The number of ANDA has reached a record high, and some companies’ export growth has exceeded 20%

The U.S. market is relatively large, the security mechanism is relatively complete, per capita income and reimbursement are relatively high, and it has become numerous in China. enterprise To explore the preferred destination of the international market, some companies with strong cost control capabilities and good software and hardware infrastructure and financial strength have started to register new drugs and generic drugs in the United States.

In 2017, Chinese companies were granted 34 ANDA numbers in the United States, setting a record high. Whether it is Huahai Pharmaceutical, Renfu, and Haizheng, etc., which are known for their internationalization, pharmaceutical companies, or Hengrui, Shiyao, Qilu, etc. Rapidly growing companies are rushing to accumulate ANDA numbers when entering the US market, and some companies that are dominated by the domestic market and emerging markets have also begun to look to the US market. Huaren Pharmaceutical, Shiqiao Bio, Ruiyang Pharmaceutical , Buchang Pharmaceutical also has a breakthrough, to achieve the first ANDA approved in the United States.

In 2017, China exported US$310 million to US-western pharmaceutical preparations, an increase of 5.4% year-on-year, accounting for 9% of China’s total exports of Western medicine preparations. Local enterprises have become the main driver of exports to the United States. Among the top 10 exports to the United States, 9 Among them, China's domestic enterprises, Huahai, Nantong Lianya, Renfu, Qilu, and Shijiao have all increased their exports by more than 20%. Qilu Pharmaceutical's nine products achieved exports to the United States, and the export volume exceeded US$8 million. Stone Drugs 2017 8 The number of ANDA was approved. The value of exports to the United States exceeded US$6 million, an increase of over 90% over the same period of the previous year. In addition, Jiangsu Haosen, Beijing Secco, Shandong Xinhua, etc. Although the export value is not large, there has been a certain breakthrough in exports to the United States in 2017. .

In 2017, China’s export to Africa was 520 million U.S. dollars, an increase of 11.2% year-on-year, which was 2.9 percentage points higher than the export of overall preparations. Nigeria, Democratic Republic of the Congo, Tanzania, Cameroon were the top four non-prescription markets in China, and accounted for China’s total non-export volume of preparations. Nearly 40% of the year-on-year increase of 24%, 43%, 52% and 27%, respectively. As dollar-denominated commodity prices began to pick up, exports to Angola, South Africa and Algeria also took off. The rate of recovery has increased by 24.9%, 5.8% and 107% year-on-year respectively. From the perspective of export products, non-export products are still concentrated on antimalarial medicines, antibiotics, anti-infectives and analgesic drugs.

China and the countries along the Belt and Road have rapid growth in foreign trade, and their preparations have achieved rapid growth in Central and Eastern Europe, the Commonwealth of Independent States, Central Asia, and South Asia, with growth rates of 53%, 31%, 19.4%, and 23%, respectively. India, Pakistan, Malaysia, Poland, Myanmar, Russia, Bangladesh, Ukraine, and Central Asia are the main forces driving the growth of Chinese medicine preparations in the 'One Belt and One Road' region. They are also the key markets for China’s pharmaceutical exports. Among them, China’s India , Pakistan, Bangladesh, Russia and Ukraine achieved growth of more than 20%, exports to Poland triple digit growth, exports to India, the Philippines, Pakistan, Thailand, and Malaysia were all above 70 million US dollars. Local western medicines exports the top five markets to the 'Belt and Road'.

There are increasing number of Chinese pharmaceutical companies that are deepening the international market. In recent years, the internationalization of Chinese preparations has witnessed rapid growth. There are more than 300 domestic Chinese companies that have been deployed in the field of preparations for internationalization.

The road to internationalization of preparations for many companies has only just begun. Emerging markets are the mainstay. Although more and more companies are entering the high-end market in the United States, investment and output are seriously out of balance, and the profitability of pharmaceutical preparations for export is still very long. The way to go.

At present, China's pharmaceutical companies have obtained more than 150 US ANDA numbers, but only about 60 have been commercialized, mainly in large-scale pharmaceutical companies such as Huahai, Hengrui, Renfu, Nantong Lianya, Qilu and Shiyao. And internationalization started earlier.

It is worth mentioning that China's pharmaceutical preparations achieved historic breakthroughs in the United States' first generic filing and patent challenges. Hengrui's cyclophosphamide, inhaled desflurane was first approved in the United States, and the patented paroxetine of Huahai Pharmaceuticals was successfully challenged and effectively improved. China's pharmaceutical companies have confidence in the internationalization of their preparations.

With the full opening of the consistency assessment and the deepening of the reform of China's review and approval system for pharmaceuticals, the internationalization of preparations has been backing the domestic 'curve overtaking' and it has also become an important choice for many Chinese companies to deploy and deepen the international market. Hua Hai, Heng Rui, Qilu, stone medicine, etc. have received a lot of benefits from this favorable policy, which has also triggered a new wave of internationalization of preparations.

With the improvement of innovation capabilities, more and more Chinese companies are willing to invest in R&D. Overseas R&D centers have been established to introduce international Talent With the development of international mergers and acquisitions, the awareness of enterprises in cultivating the international market has been gradually strengthened. Even in individual fields, it has been able to compete with the advanced level in Europe and the United States, and the number of new drugs declared has gradually become blowout.

Such as green leaf risperidone sustained-release microspheres intramuscular injection exempt clinical trials; Shiyao and Teva, citron, and other international generic pharmaceutical companies signed an overseas technology licensing and commercialization cooperation agreement, and two products in the United States to obtain orphan drug qualifications Beijing Teide, Hengrui, Qilu and many other companies have passed the most stringent Japanese PMDA certification and sold the formulated products to the Japanese market.

Emerging markets based on generic drugs have broad prospects for development. They have relatively low entry barriers and have a strong demand for pharmaceuticals in China. They have become a key market for Chinese pharmaceutical companies to develop and pay attention to. In 2017, China's pharmaceutical industry was emerging outside Europe, America, Japan, and Australia. The market exports exceeded US$2 billion, accounting for nearly 60% of the total exports of pharmaceutical preparations. According to incomplete statistics, there are currently nearly 400 products registered in emerging markets in China, such as Ruiyang, Huayao, Zhongning, Shiyao, and Tokyo Shiwei. The enterprises represented by Jiangsu Kaiyuan and Shisi Pharmaceutical have taken the emerging market as the main target and deepened the market along the “Belt and Road” market. In recent years, exports have achieved significant growth.

In 2018, the global economy is expected to regain growth momentum, but the recovery process is still slow. The advanced economies performed well and their growth expectations have been raised compared to last year, but the overall pharmaceutical market has slowed down, and is expected to maintain 2%~5. The growth rate of %. The United States still maintains the position of the world's largest pharmaceutical market. The size of generic drugs market is approximately 70 billion US dollars. In the future, Chinese companies will have more and more new drugs and generic drugs approved in the United States, but pharmaceuticals in the US market will soon be replaced. The original research and protection cycle is long, the price competition of generic drugs is fierce, and the market speed of generic drugs exceeds the market growth rate. It is difficult for China's preparations to make major breakthroughs in the short-term commercialization of the U.S. economy. The overall economy of the Eurozone has improved, but has been affected by the United Kingdom. With the influence of debts and refugees from France, Italy and other factors, the economic and regulatory environment still have great uncertainties.

The emerging pharmaceutical market is expected to remain at 6% to 9% growth in 2018, which is significantly higher than the overall global growth level. The CIS region, Mexico, Nigeria, etc. will gradually overcome the impact of the low price of the oil and gas market; Croatia, Serbia and other Central and Eastern European countries. Regional control of drug prices, restricting the entry of some new drugs, and increasing the use of generic drugs will create opportunities for exports of pharmaceutical preparations in China. However, due to falling GDP and depreciation of currencies in major emerging economies, drug spending has decreased, plus many regions. Began to encourage localized production, the future growth of China's preparations to emerging markets will also be restricted by many parties.

From the perspective of domestic environment, China’s macro economy will continue to improve steadily and steadily over the past year. In 2017, the CFDA issued a series of documents that conditionally accept data from overseas clinical trials, emphasizing the review of collinear varieties through the rear view. The adoption of conformity assessment, the reform of import drug registration management requirements, the trial of the market licensor system, and the addition of ICH have not only benefited the formulation of internationalized 'going out' enterprises, but also attracted more and more foreign companies to pay attention to the Chinese market.

According to a comprehensive analysis, in 2018 China's foreign trade for preparations basically met the basic conditions of maintaining good conditions. More and more enterprises started domestic and international applications for simultaneous declarations and formulations, but the task remains arduous and requires the joint efforts of the government, industry, and the business community. .