[picture] China's pharmaceutical internationalization has begun to take shape

Source: China Chamber of Commerce for the import and export of pharmaceutical and health care products 2016-05-09 at present, the internationalization of Chinese pharmaceutical industry is gradually from ideal to reality Over the past decade, Chinese pharmaceutical enterprises have gone through an extraordinary road of Internationalization: from becoming the largest API in the world From suppliers to large-scale sales of high-quality preparations in European and American high-end markets, to all-round and multi-level participation in global pharmaceutical industry competition and cooperation, international high-end market certification and registration, inspection by European and American regulatory authorities and international organizations, application for new drug research and development overseas, a large number of leading enterprises are engaged in intensive work and see internationalization as the future development vision As one of the largest pharmaceutical international exhibitions facing the world in Asia, CPHI China has witnessed the international cultivation of Chinese pharmaceutical enterprises in the past 16 years With every step of internationalization, CPHI China exhibition has also continued to extend up and down the industrial chain, providing a stage for a group of excellent Chinese pharmaceutical enterprises to enter the international market Now, what is the prospect of internationalization of Chinese pharmaceutical enterprises? From a perspective, the performance of exhibitors in CPHI China can give the answer Innovation driven internationalization as an important fulcrum of future development, transformation and upgrading has developed to the critical stage involving the life and death of enterprises, rather than just the concept Deepening internationalization and formulating corresponding strategies and strategies has become one of the important strategies on the road of enterprise transformation, and more and more enterprises pay attention to it Yabao Pharmaceutical Co., Ltd has positioned innovation and internationalization as two major strategies for the future development of the company The company said that internationalization is the only way for the company to go after a certain stage of development It hopes to take the company's management level and product quality to a new level through continuous internationalization, and at the same time feed the domestic market so that Chinese people can eat drugs that meet international standards 7 The preparation of whopq certification (who pre certification) began eight years ago, during which a lot of money was invested to realize the vision of becoming a global supplier of high-quality hormone APIs and preparations It is more difficult to carry out international high-end market certification and registration as the cornerstone of internationalization than other industries in terms of international registration, certification, supervision and other aspects due to the special nature of the pharmaceutical industry, but it is also the only way to enter the international market In recent years, with the continuous improvement of the technical level and GMP management level of Chinese pharmaceutical enterprises, it has made great achievements in international high-end registration and certification The reproductive health drugs levonorgestrel, ethinylestradiol and mifepristone APIs of China Resources Zizhu Pharmaceutical Co., Ltd have respectively passed the whopq certification, levonorgestrel and ethinylestradiol have obtained the European CEP Certificate (European Pharmacopoeia adaptability certificate); the products of mifepristone, levonorgestrel, estrone, tibolone and dinoprostone have obtained the DMF document (drug master document) of the United States In the past 10 years, 13 antimalarial preparations of Guilin south medicine have obtained whopq certification Its artesunate series innovative drugs (including oral preparations and injections) have helped nearly 200 million malaria patients recover health and saved more than 7 million lives of severe malaria patients Beijing New Pharmaceutical Co., Ltd has successfully passed the GMP on-site inspection of EU for four times in a row, with the capacity of 4 billion granules in two solid preparation workshops, and has established the international registration department, which has increased the efforts to develop anda In recent years, the internationalization of China's pharmaceutical industry has not only been fixed in the trade side At present, more and more pharmaceutical enterprises have established overseas factories, branches and R & D institutions, patent authorization and transfer, and international M & A To participate in international market competition in various ways and strive to integrate and allocate resources within the scope of international market The internationalization strategy of Yabao pharmaceutical industry is "going out" and "bringing in" On the one hand, Yabao pharmaceutical R & D company is established in the United States to recruit overseas senior talents for drug R & D, and at the same time, it introduces original innovative drugs through cooperation with foreign pharmaceutical companies, and seeks opportunities for overseas M & A and patent purchase; In 2015, Hengrui pharmaceutical transferred the R & D and sales rights of shr1210 (PD-1) monoclonal antibody to Incyte company in the United States for compensation; Fosun Pharmaceutical purchased ambrx, a biotechnology company engaged in clinical R & D in the United States, in cooperation with relevant capital parties in 2015; Humanwell pharmaceutical established humanwell Africa Pharmaceutical Co., Ltd in Mali, Africa, and established a large infusion and syrup production line, which is expected to become the largest pharmaceutical factory in West Africa after completion this year At the same time, the enterprise has realized localized operation through multiple channels such as building factories and setting up branches overseas, avoiding technical and trade barriers On the one hand, relying on the resources accumulated in the foreign trade industry for many years, the enterprise consolidates the relationship with the agents of various regions and countries, communicates with the agents every year to formulate the annual plan to ensure the stable growth of exports On the other hand, it actively distributes the international market sales network through various channels: Huahai Pharmaceutical Co., Ltd cultivates the international market in every region, sets up an office in the local area, recruits local personnel, understands the local laws and regulations, especially the registration requirements for medical products entering the local area, and establishes an international sales network After more than 10 years' efforts, Huahai has exported its pharmaceutical products to developed countries such as the United States and Europe on a large scale, and constantly increased its market share China Resources Zizhu Pharmaceutical Co., Ltd has set up two development teams, i.e standard market and non-standard market, to adopt different sales strategies for different levels of markets, study the access mechanism, laws and regulations of different markets, and build a hierarchical sales network At the same time, China Resources Zizhu, Guilin Nanyao and other enterprises pay attention to international bidding procurement, foreign aid and other channels of foreign sales According to incomplete statistics, more than 30 international multi center clinical trial drugs of Chinese enterprises have been actively promoted It is worth noting that in 2015, serroton capsule of Shenwei Pharmaceutical Co., Ltd and Lianhua Qingwen capsule of Yiling Pharmaceutical Co., Ltd carried out phase II clinical trials in Australia and the United States respectively, and the pace of RE development of traditional Chinese medicine in China is stepping into the world Risperidone injection developed by LVYE pharmaceutical can submit a new drug application (NDA) in the United States without additional clinical trials, which marks that the first microsphere product independently developed by China is about to enter the U.S market In the past 16 years, CPHI China has been introduced into China since 2001 It has built a professional trade platform for Chinese pharmaceutical enterprises on the international stage, which is in line with other overseas 8 With its huge global industry data resources, series exhibitions have developed into an industry exhibition with specialization, internationalization and high-end as the core competitiveness, become an important driving force for industry development, and also achieve the pharmaceutical Chinese dream of a large number of excellent enterprises As the Chinese sponsor of the exhibition, the chamber of Commerce for medical insurance pays more attention to integrating resources of all parties and helping Chinese pharmaceutical enterprises to enter the international market In order to improve the international recognition and influence of Chinese pharmaceutical internationalization leading enterprises, encourage international innovation, and set an industry benchmark for China's pharmaceutical internationalization strategy, the chamber of Commerce for medical insurance has launched the "top 100 pharmaceutical internationalization enterprises selection activity" this year, which will award "international market high-quality suppliers and partners" to excellent enterprises in the process of pharmaceutical internationalization in 2015 ”"Leading enterprise in pharmaceutical internationalization", "best international R & D innovative enterprise", "best multinational pharmaceutical investment enterprise" and other major awards This award will not only encourage Chinese pharmaceutical enterprises to participate in international innovation, but also further improve the international influence of award-winning enterprises CPHI China will work hand in hand with Chinese pharmaceutical companies to make unremitting efforts to realize China's pharmaceutical dream.