Wang Wei: Chinese preparations have great potential in European and American markets

In recent years, the pharmaceutical emerging market with China as a typical representative has developed rapidly, but the European, American and Japanese markets are still the mainstream of the world. During the "12th Five-Year Plan" period, China has more than 30 pharmaceutical companies that have obtained relevant certifications from Europe, the United States and Japan. This has laid a solid foundation for China's preparations to carry out international competition and open the international market. So, what is the potential of Chinese preparations in the European and American markets? Recently, on the related issues, he had an exclusive interview with the deputy general manager of Zhejiang Huahai Pharmaceutical Co., Ltd. and the general manager of Zhejiang Huahai Pharmaceutical Sales Co., Ltd. Wang Hao.

Lack of long-term, overall international development strategies, and lack of leading talents and teams who are familiar with international business are issues that need to be faced in the internationalization of domestic pharmaceutical companies.

From the company's own capabilities, the overall development of the industry, the system, etc. efforts to accelerate the development of the internationalization of Chinese preparations.

Medical Observer: The rigidness of the pharmaceutical industry determines that this industry is a rising, promising and sustainable industry. This is also the main reason why the global pharmaceutical industry has continued to show steady growth in recent years. Combining the current status of the international market development, you believe that the future What are the trends in the international preparation market?

Wang Hao: In recent years, due to the global exhaustion of compound reserves, the arrival of bottlenecks in the development of pharmaceutical technology, the increase in drug safety and efficacy requirements, and the increase in the threshold for approval of new drugs, the speed of new drug launches in the international formulation market has slowed down significantly, and the number of new drugs has also decreased. There are fewer “bombshell” drugs; at the same time, the rapid development of the generic market has made it the mainstream of the drug market. In addition, in recent years, the value of biopharmaceuticals in the international formulation market has also grown rapidly. Biopharmaceuticals account for the world’s top 20 sales, and it is expected that by 2014, the top six sales will be biopharmaceuticals. .

In addition, there is also a very large market characteristic. In recent years, the emerging markets represented by China have developed rapidly. However, the markets in Europe, America, and Japan are still the mainstream of the world. It is understood that the annual growth rate of seven countries such as China, Brazil and India exceeds 8%, while the annual growth rate of mature markets in Europe, America and Japan is only 3%-7%. In terms of market size, China’s market size reached US$31.1 billion in 2009, ranking fifth, with a growth rate of 22.7%; Brazil’s market size reached 16.7 billion, ranking tenth, with a growth rate of 20.1%; US market size USD 308.2 billion, still in the first place, with a growth rate of 4.1%; Japan's market size is USD 83.7 billion, ranking second, with a growth rate of 1.9%; Europe's five countries total USD 150 billion with an increase rate of 1.3 %-4.9%. Overall, the market share of the five European countries and the mature markets in the United States and Japan still dominates and remains above 69%.

Medical Observer: As you said, the European and American markets are still the global mainstream market, which also points the way for the internationalization of Chinese pharmaceutical preparations and demonstrates its necessity. In terms of the status quo, the internationalization of preparations in China has also achieved some results. Does this lay a solid foundation for the internationalization of Chinese pharmaceutical companies?

Wang Hao: Yes, the first thing to be clear is that although the size of emerging markets such as China has started to grow rapidly in recent years, but now, Europe and the United States are still the mainstream market, and this market is worthy of attention by domestic pharmaceutical companies. In recent years, domestic preparations have indeed made some breakthroughs: During the “Eleventh Five-Year Plan” period, under the vigorous promotion of China’s national policies, many Chinese pharmaceutical companies have begun to enter the authoritative mainstream markets such as the United States and Europe. Seven companies have passed FDA certification, some of which have obtained ANDA's license, and 18 companies have been certified by the WHO. During the "12th Five-Year Plan" period, more than 30 pharmaceutical companies in China have obtained relevant certifications from Europe, America and Japan. This laid a solid foundation for China's preparations to carry out international competition and open the international market.

It should be noted that compared with India, which is also an emerging market, our country still has a certain distance. It can be said that the internationalization of preparations in our country has only just begun. However, in the long run, the large-scale export of preparations of pharmaceutical companies in China will inevitably be achieved. A great deal of development. In the main development goals of the “12th Five-Year Plan” of China's pharmaceutical industry, the export volume of pharmaceutical preparations in 2015 should reach US$9 billion, accounting for 10% of the total export volume, and more than 50 companies should establish pharmaceutical R&D centers and production abroad. base.

Only by adjusting the horizons can we seize the opportunity for medical observers: As such, the potential of Chinese preparations in European and American markets is indeed very large. However, due to the various characteristics of large-scale export of pharmaceutical preparations, China’s large-scale export of preparations still faces many difficulties. From the perspectives of self, industry development, and system, what do you think is the main difficulty?

Wang Hao: First of all, with regard to the characteristics of the export of large-scale preparations, China's large-scale sales of pharmaceutical preparations are mainly oral preparations. In addition, the export of preparations is a systematic project, which not only imposes high requirements on the innovation and quality of pharmaceuticals, but also puts forward many requirements for the company's team, production capacity, logistics system, and market development strategies. At the same time, the export of large-scale pharmaceutical preparations also has the characteristics of large investment and long-term investment, and it is very complex. It is a manifestation that it must accept various issues in the forms of approval risk and tort law risk. In addition, its characteristics are also expressed as high demands on the overall strength of the company and the industry, such as innovation and development, the strength of the first generic drug development strength and so on.

At present, domestic pharmaceutical companies still have many deficiencies: lack of a long-term overall international development strategy, lack of leading talents and teams that are familiar with internationalized business, limited enterprise resources, unbalanced development, and lack of scale production according to GMP standards. practical experience. This has also caused some retail and wholesale companies in Europe and the United States to have greater problems in trusting Chinese medicines.

The incompleteness of industry resources is also a problem that must be faced. For example, China's APIs lack cGMP standard management and DMF registration capabilities, and there are still gaps compared with Indian companies. In addition, there is a serious mismatch in industry resource packages. For example, none of the plastic medicine bottle manufacturers that manufacture drugs in China have passed the US FDA certification. In China, there are very few adjuvants that are currently included in the National Pharmacopoeia. The known 543 adjuvants are basically chemical grade products. Including pharmaceutical equipment, each device must have a verification certificate, but many of the equipment in China may be very advanced, but there is no verification certificate. In this way, the FDA will not recognize it.

In addition, there are also institutional difficulties, we lack the support of mature national financing channels, such as the lack of a complete set of operational procedures for the mergers and acquisitions and operations familiar business operations team.

Medical observers: These problems are undoubtedly the biggest obstacle to China's internationalization of pharmaceutical preparations. This also means that for domestic pharmaceutical companies, if they want to achieve long-term development in the international markets such as Europe and the United States, they must recognize their own and industry inadequacies, remedy the situation, and thus To live in opportunities, specifically, what efforts should be made?

Wang Hao: In the first aspect, companies need to diligently work hard—to formulate a long-term development strategy, to take the road of common development, to cultivate a team with corporate characteristics, to obtain a certain number of symbols, and to implement robust and lasting market development strategies; Develop smooth sales channels; make full use of manufacturing advantages, cost advantages, and vertical integration advantages; have the ability to guide patent services and capital operations; actively establish a combination of independent and outsourced R&D teams at home and abroad to ensure a complete talent system And research and development system; long-term market development plan, and the formation of suitable for the company's actual international market development strategy; in-depth study of national cultural and traditional laws; actively seek opportunities for mergers and acquisitions.

Second, it also needs to accelerate the promotion of the industry. The Twelfth Five-Year Plan gives us a joy and a great opportunity, so the state should increase its efforts in new types of pharmaceutical excipients, packaging equipment, etc., in order to speed up the development and application of preparation technology. At the same time, the expansion of internationally-requested clinical trial centers has not yet achieved zero breakthroughs. China has not yet been approved by the FDA as a BE trial center. In addition, there is also a need to simplify customs clearance procedures for imported blood samples.

The third aspect is to rationalize the system. We will increase the financial support for the research and development of export formulation products, improve the tax rebate policy that facilitates the export of high-value-added products, and implement the deduction policy for the addition of R&D expenses. In addition, we will streamline the financial channels for domestic foreign loans, implement and improve export credits, and support compliance. The conditions for pharmaceutical companies to issue bonds and listing at home and abroad, in addition, the need to improve the clinical trials and product liability insurance policies. From these efforts, China's preparations can better seize the opportunities in the international market.