At present, 80% of China's pharmaceutical exports are APIs, which are facing the situation of huge production capacity, fierce price competition and generally low profits, while the export of downstream preparations only accounts for 10%.

In the past five years, especially in the past two years, the situation is undergoing positive changes. More and more local pharmaceutical enterprises have joined the ranks of internationalization, strengthened the international standard market registration and certification and market channel construction, and sold pharmaceutical products to overseas scale.

In the past five years, the number of domestic pharmaceutical companies obtaining anda in the United States has increased significantly from single digit to 75. At the same time, the products of local pharmaceutical enterprises are exported to Europe and the United States to realize rapid growth.

Xu Ming, vice president of China Chamber of Commerce for import and export of health care products, said: "from the perspective of trend, the transformation from API to preparation is a new direction of internationalization. At present, it is impossible for the export of pharmaceutical preparations to replace the API. The API is large in scale and volume, and the transformation is not easy. APIs should also find their own way of development. "

From API to high end preparation

In 2016, China's exports of Western medicine reached US $31.483 billion, accounting for 56.8% of China's pharmaceutical exports. At the same time, the number of overseas M & A of Chinese medicine has reached 25, the amount of M & A has exceeded US $5.5 billion, and the number of American anda has reached 75.

From the perspective of trend, Chinese pharmaceutical enterprises are starting industrial upgrading along the path of India: the path of API → characteristic API → generic → innovative drug is increasingly clear, the international core competitiveness of Chinese Western medicine is significantly improved, and the internationalization of pharmaceutical industry starts a new journey.

In terms of export regions, Africa and Asia were the export markets of Chinese preparations in 2012, accounting for 64.63% of the total export share. In 2016, the market share of Africa and Asia has dropped to 54.3%, while the proportion of the United States and the European Union has increased from 15.87% to 28.9%. This shows that the level of Chinese pharmaceutical export products is improving, the concept of enterprises is changing, and more attention is paid to regulating the pharmaceutical market to obtain higher profit margin.

Despite the rapid progress of internationalization, local enterprises are facing great challenges in the face of the current industry situation. On the one hand, traditional API enterprises upgrade their products, increase R & D investment, and form closer strategic cooperation with multinational pharmaceutical enterprises; On the other hand, in recent years, the arrival of "patent cliff" and the increase of R & D cost have accelerated the outsourcing process of global large pharmaceutical enterprises.

Industry insiders have reached a consensus: API is the basis for the development of preparations. Without strong API production capacity, there will be no production capacity of preparations.

For example, Qilu pharmaceutical has been unswervingly promoting its internationalization strategy. In the process of continuously and deeply participating in the division of labor in the international pharmaceutical industry, Qilu pharmaceutical's position has been constantly improved, and it has been constantly leaping to the top of the value chain of the international pharmaceutical industry. Its product exports have expanded from raw materials to preparations.

Especially in recent years, the company's high-end preparations continue to achieve breakthroughs in export to high-end markets including the United States, the United Kingdom, Germany, Japan, etc.

Looking for its own superior varieties

At present, Qilu pharmaceutical has more than 50% market share in the United States, Japan, Australia, New Zealand and other places. Taking the U.S. market as an example, Qilu pharmaceutical started with the export of 4.4 million ondansetron hydrochloride injection to the United States in March 2016, and has successively realized the export of seven products to the United States, covering two major fields of anti-tumor and anti infection.

Among them, five new products were added this year, with a blowout growth in both quantity and amount. In terms of export volume, up to now, it is close to US $9 million, and the annual figure will exceed US $10 million, with a year-on-year increase of more than 500%.

From the successful experience, it is very important to find the right product. Xu Yifu, deputy general manager of Hengrui medicine, said: "in the first half of the year, the company continued to strengthen the implementation of the international strategy and actively explore the international market. Products such as cisatracurium besylate injection and caspofungin acetate for injection were approved to be sold overseas, and the sales of series products such as cyclophosphamide for injection increased steadily; Europe, the United States and Japan regulate the market and carry out the registration and declaration work according to the plan. "

Yuanda Shuyang has formed a product system of 8 varieties and 23 specifications of blood products, which takes the lead in export while serving the domestic market. Now it has completed the export registration in 9 countries, and has realized export sales to 7 countries.

Jiang Dexi, general manager of Yuanda Shuyang, said: "the key to developing the international market is to find out the strategic fit point and market commanding height. In addition to developed countries in Europe and the United States, blood products are still in the industrial blank in many countries.

Chinese enterprises are fully qualified and capable of exporting products, talents and technologies. They can not only open up a blue ocean in the market, but also improve and consolidate the partnership between China and these countries from the perspective of improving medical and health security. "

LIANG Qing, President of Anhui Hua'an, holds the same view. He emphasizes: "the important thing is to drive characteristic products: develop characteristic products and strengthen the competitiveness of core products; Extended service platform: overseas companies provide localization services for target markets; In terms of internationalization of preparations, European pharmaceutical companies were established to register OTC and high-end generic drugs, expand commercial space, and continue to increase R & D investment. "