Huahai 5 years more than 80 AND Baiji 95 overseas clinical trials Pharmaceutical enterprises out to sea 2.0 era began.

The pattern of Chinese pharmaceutical companies going out to sea has changed.
10 years ago, China's pharmaceutical exports mainly raw materials, export markets are relatively concentrated in a few key markets, new drug applications, low level of research and development, manufacturing research and development outsourcing capacity is weak, international competition is mainly reflected in the cost advantage, after 10 years of development, China's pharmaceutical import structure occurred significantly Changes, the proportion of imports of raw materials decreased from 28.79 percent to 14.96 percent, the export structure improved significantly, and the export capacity of Western pharmaceutical preparations and medical equipment increased, increasing by 2.6 times and 1.7 times, respectively.
with the improvement of the scale, research and development and innovation of domestic pharmaceutical enterprises, the internationalization of China's pharmaceutical industry has not only been limited to the field of API exports, but also involves preparations, original innovative drugs, capital and other aspects.
If the past 10 years of medicine out to sea attention to quality system, research and development capabilities and product pipeline upgrading as the 1.0 era of pharmaceutical companies out to sea, then in the Black Swan incident frequently out of the current, China's pharmaceutical companies are about to open the 2.0 era, each pharmaceutical companies in the process of internationalization must be more accurate analysis of the market, interpretation of the market, positioning products, to develop their own strategies and actions, to find an effective way for enterprises to go out to sea to become bigger and stronger.
2020 Blue Book on the Internationalization of China's Pharmaceutical Industry (hereinafter referred to as the Blue Book) jointly published by the China Medical and Health Products Exporters Association and CoreVean may provide some references.
01 API deep participation in the global industrial chain CRO/CMO performance active API has been a banner of the internationalization of Chinese medicine.
China has become the world's largest production base of API since 2010, responsible for more than one-third of the world's raw material supply.
past decade, China's API exports have increased 2.2-fold from 4.6036 million tons to 10.1185 million tons, indicating that Chinese API is becoming more popular and more important in the international market.
to China's API exports, I have to mention India, China's largest exporter of API.
70 per cent of India's imports of API come from China, with a higher proportion of intermediates.
despite the Indian government's strong support for Indian manufacturing and the construction of raw material parks across India, and the upstream development of many Indian pharmaceutical companies, it is still difficult to get rid of dependence on Chinese raw materials in the short term.
only in the international market to do irreplaceable, can be at ease, especially since this year, the United States and European markets began to frequently call for the independent production of RAW drugs, committed to get rid of the current Chinese API.
Chinese API has been deeply involved in the global industrial chain.
more than 3,200 companies worldwide are engaged in API production activities, but complementary businesses lack integration, with only one-third of the companies affiliated with groups with preparation capacity, according to Krysan Newport.
, despite the large number of mergers and acquisitions over the past few years, it has been difficult to shake the position of Chinese API in the international market.
the Blue Book analysis, this kind of decentralized production makes enterprises continue to pursue mastering professional skills, increase market share or enter new markets.
addition, many Chinese API manufacturers are long-term stable suppliers of multinational pharmaceutical companies, China's API in the global market irreplaceable enhancement.
Some new changes in the international API market have also provided new opportunities and new ideas for the development of China's API industry, such as the RAW drug contract research and development organization CRO and the contract production organization CMO are becoming more and more active, enriching the development mode of API enterprises.
the contract organizations such as Mingkangde and Kailaiying have grown steadily, and traditional API companies such as Kyushua Pharmaceuticals and Prop Pharmaceuticals have also ushered in new business growth points.
, China's API companies have moved from extensive low-end intermediates to sophisticated mid- to high-end products, extending and shifting downstream supply chains and increasing deep processing capabilities.
And China's API enterprises are increasing in size, the number of medium-sized enterprises increased significantly, in 2019 the number of enterprises exporting more than 100 million U.S. dollars increased by 7.5% YoY, the number of export enterprises above 50 million U.S. dollars increased by 11.8% YoY, and the number of enterprises above 10 million U.S. dollars increased by 17.6% YoY.
in such a competitive situation, China's API companies have no choice but to go all the way to high quality.
02 ANDA outbreak Huahai 5 years more than 80 ANDA steady stand the first echelon of China's medicine internationalization began with raw materials, but the preparation is the internationalization of the "long arrow."
the export of raw materials to be produced into preparations sold around the world, almost invisible to the shadow of API companies.
and preparations are very different, exported to the international market, can be more intuitive to consumers to see.
The first approval of three complex preparation products in the U.S. in 2019 for three complex preparation products, Dongsun Fingolimod capsule (0.5mg), Xuantai Pharmaceuticals' Bosaconazole intestinal solution (100mg) and Fosun's Gland pharma injection (20mg/L), shows that the research and development and internationalization strength of Chinese pharmaceutical companies have been further enhanced, effectively enhancing the confidence of enterprises in the internationalization of pharmaceutical preparations.
years, China's preparations to the sea gradually towards the norm, and The number of Chinese preparations approved in the United States ANDA showed explosive growth.
2010-2014, the average annual number of preparations in China is only 20, from 2010 onwards, China's pharmaceutical industry has made great sedition, enterprises go to sea enthusiasm is high, from 2015 onwards, Chinese enterprises into the ANDA harvest period, by 2019 has soared to 163 numbers.
2019, there were 288 free-brand preparations listed overseas in China, mainly in new market countries, and 20 free-brand preparations listed in the United States, 8 in Switzerland and 5 in Germany, according to
CoreLogic data.
the dosage form, 156 oral preparations, accounting for more than 50%, 85 injection preparations, 31 local medication.
more than 400 local Pharmaceutical companies in China, most of which are concentrated in new markets.
But with the promotion of domestic generic drug belt procurement, innovation and internationalization has become one of the sharp weapons for enterprises to get rid of the impact of domestic bidding and price reduction, more and more enterprises will look to Europe, the United States and Japan and other strict regulatory markets, began to carry out China and the United States, China and europe double-report layout.
It's a lot of money, these companies get the U.S.ANDA and the European Union certification not only for their overseas business revenues, and generic drugs overseas approval is also conducive to domestic, and thus enhance competitiveness at home.
the end of 2019, Chinese pharmaceutical companies have obtained more than 300 ANDA numbers in the United States, commercial sales of about 100 products, China has more than 300 preparation sites through the European Union GMP certification, in the last three years there are 86.
Huahai is one of them.
In 2015-2019, Huahai obtained more than 80 ANDA units, and at the same time established overseas marketing networks and expanded overseas markets, it also began to return to the local market, first tasted the competitive advantage of the market brought about by the global synchronous quality system and cost control under the 4-plus-7 collection policy.
At the same time, the second and third tier teams continue to grow, the number of approved significantly increased, in 2019 the United States ANDA approved by the New Faces of Chinese enterprises, Hainan Shuangcheng, Zhengda Group, Jiangxi Boya and Pro Pharmaceuticals.
, however, from the approved AND dosage form, China's AND dosage form is relatively single, mainly oral preparations and injections, the proportion reached 81%, and 16%, respectively.
local preparation companies are rising overseas.
In 2019, exports to the United States of millions of U.S. dollars or more of China's domestic enterprises reached 29, exports to the United States of America, the top 20 enterprises, Chinese enterprises accounted for 18, and 12 are chinese domestic enterprises, NantongLianYa, Renfu Pharmaceuticals, Shi Pharmaceutical Group, Qilu Pharmaceuticals and other export growth rate of more than 30%.
Nanjing Jianyou, Shanghai Xuantai, Changzhou Pharmaceuticals, Anto Pharmaceuticals, Ealing Pharmaceuticals and other enterprises in the commercialization of the United States made breakthrough progress, exports achieved triple-digit growth.
, Hainan Huayi Taikang, Qingdao Baiyang and other enterprises of high-end slow release preparations also appeared for the first time to the United States exports.
In 2019, the top 25 enterprises exported to the EU, 23 local enterprises in China, 20 local enterprises with exports of more than US$5 million, an increase of 9 from two years ago, Shenzhen Tiando, Shanghai Rongheng, Guilin Nan Pharmaceuticals, Ruiyang Pharmaceuticals, Shandong Xinhua, Shenzhen Zhijun, Huayi Pharmaceuticals and other exports to the Eu have achieved a relatively large increase.
03 5 years 340 overseas clinical trials Baiji Shenzhou 95 dominant China's large pharmaceutical companies to achieve internationalization, with a global perspective and rich experience in early research and clinical research core team is the cornerstone.
the Blue Book, the number of clinical trials conducted overseas in China and the number of countries selected for international multi-center trials in 2019 are at an all-time high, and companies are increasingly willing to go global and compete.
more than 340 clinical trials conducted overseas between 2015 and 2019.
, however, only 48 in 2015 did not show significant growth until 2017, with 103 new additions in 2019, an increase of 115 per cent over 2015.
and the number of overseas clinical trials distributed by Chinese companies has increased significantly.
2015, domestic companies conducted clinical trials in only 14 countries overseas.
2019, overseas clinical trials will be conducted in 51 countries, with a record number of countries.
In recent years, more and more Chinese enterprises have carried out clinical trials overseas, and Baiji Shenzhou is the largest overseas clinical trial, followed by Jiangsu Hengrui, Shandong Green Leaf, Hutchison Whampoa, Yasheng Pharmaceuticals, Qilu Pharmaceuticals and so on.
is dominated by the United States, Australia, Europe, Japan and South Korea in the Asia-Pacific region, especially in Europe, the number of clinical trials far exceeds that of other domestic enterprises.
, Jiangsu, is dominated by Australia, followed by the United States, with only a few trials conducted in Europe.
Pharmaceuticals is dominated by India, australia and Europe are also involved.
green leaves mainly in the United States, Europe and Japan have also carried out a small number of experiments.
major pharmaceutical companies overseas clinical trial stage with the largest clinical phase, accounting for about 48% of all trials, clinical phase II and clinical phase III accounted for 17% and 16%, respectively.
and intestinal disorders have been a hot topic in overseas clinical trials for five years in a row.
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