Business Club October 18th More and more Chinese companies are working hard to sell their formulations to international high-end markets. Recently, good news frequently spread: In early June, Shijiazhuang Group's oral solid preparation workshop successfully passed the on-site inspection by the US Food and Drug Administration (FDA); at the beginning of August, Tasly announced its flagship product, Compound Danshen Dripping Pills. The FDA-approved Phase II clinical trial was completed in early 2010 and is about to enter phase III clinical trials. At the end of August, Hisun Pharmaceutical announced that the Tacrolimus capsule jointly developed by the company and Spanish CINFA has been approved by the European Union to become a The only approved tacrolimus generic drug in the EU market...

There is no doubt that domestic pharmaceutical companies are trying to play a more important role in the international pharmaceutical industry. At the same time, the reporter learned that the "Special Implementation Plan for Upgrading the Quality of Pharmaceutical Preparations System" led by the Development and Reform Commission and other departments is about to be passed. This special project aims to encourage domestic pharmaceutical companies to upgrade the quality of preparations, encourage local pharmaceutical companies to actively carry out cGMP standard certifications in the United States and the European Union, and increase support for enterprises that have passed cGMP certification. It is the common aspiration of the government and many companies to let Chinese medicine embark on an internationalized "elite road."

As we all know, China is already a world-leading pharmaceutical country, and its production and export of APIs and intermediates are among the highest in the world. However, the production and quality of pharmaceutical preparations are still relatively backward. In the past few years, several pharmaceutical companies in China have initiated plans to export high-end pharmaceutical products. At present, more than 20 pharmaceutical manufacturers have passed the European EDQM and FDA certifications.

At the end of August, Hisun Pharmaceutical announced that the tacrolimus capsule jointly developed by the company and Spain CINFA was approved by the European Union. Following tacrolimus, there are still many varieties that will enter the declaration of European pharmaceutical preparations. The European market is currently Is the main direction of the company's preparations for internationalization, and the application of ANDA to the US FDA is the focus of the next step. Tasly's flagship product, Compound Danshen Dripping Pills, passed Phase II clinical trials in the United States, conveying an exciting message to Chinese companies: The road to internationalization of Chinese medicine preparations is starting.

However, passing the FDA certification does not mean that Chinese medicines can be sold in US pharmacies. Xu Ming, general secretary of the China Chamber of Commerce for the Import and Export of Medicines and Health Products, said that most western medicine manufacturers in China are small-scale, weak in comprehensive strength, lack investment in R&D, and have less self-owned brand products. 97% of export products are generic drugs and their technical content is low. Some companies have passed the European and American certification, but there are fewer orders, and there are few western medicine preparations successfully listed in the developed countries. He believes that lack of international competitiveness is a common problem among local drug companies.

According to the statistics released by the Ministry of Commerce in August, in the first half of 2010, the export value of western medicine preparations in China showed a steady increase, with the export value of US$697 million, a year-on-year increase of 33.46%; among the top ten export companies, non-Hong Kong-owned foreign companies There are four investment companies, namely Pfizer, Zhucheng Dongxiao, Tianjin Takeda, and Lilly Suzhou Pharmaceutical. With their independent intellectual property rights and brand channel advantages, they have become the “leader” for the export of western medicines in China. Moreover, exports to the developed countries are also mainly driven by foreign-funded enterprises, and the proportion of their exports is as high as 52%. According to statistics, South Korea, as the country’s largest exporter of western medicines, exports mainly to Pfizer, Shanghai Roche and Tianjin Shiweiya, which account for 53% of the total; exports to the United States mainly include dietary supplements and food additives. Vitamins and some antibiotics that enter the company's identity, the main exporters are Pfizer, Jiangsu Jiangshan and Zhejiang Kangle Pharmaceuticals; exports to Japan are mainly composed of three Japanese companies: Tianjin Takeda, Qingdao Huazhong, Beijing Taide and Bayer. The proportion is as high as 75%, while exports to Africa and South America are almost entirely absorbed by local Chinese companies.

“It can be seen that the preparation products of local companies still use emerging countries such as Africa and Latin America as the main market, but have not entered the mainstream markets in Europe and the United States.” Xu Ming said that although the industry has been hotly discussing the topic of Chinese formulations to the world, companies are also active Efforts have been made, but there has been no major breakthrough in the export of preparations. In addition to the increase in export volume in Southeast Asia and other underdeveloped countries, access to the North American market has always been difficult to achieve. The situation in entering the European market is slightly better, but most of them are through OEM methods, and the export of the self-controlled preparations of Indian pharmaceutical companies is very large. the difference.

“Some companies are taking the 'green channel': Although they have passed the FDA certification, they only do OEM processing, and the final destination of the products is not the United States, but other countries. Some of the exports take place within the multinational companies. It is within the company's internal trade, but it has also been counted in the export data.” An industry source stated that even if foreign-funded enterprises hold up half of China’s Western medicines exports, the market gates of developed countries have not opened up to Chinese companies. As the preparation market needs a stable end-network support, companies must establish a close channel cooperation relationship with the European and American markets. However, Chinese companies generally lack international operating experience. Crossing the threshold can only be a successful first step. To put medicines on the shelves of US pharmacies, it is still necessary to go through a difficult journey.

"Folding Signs" Gain Multi-Stage Advantages

“It can be seen that although the preparations market in developed countries is tempting, only a few companies have the hope of opening up.” Xu Ming frankly pointed out that this is an “elite road” that is not for everyone and this road is only for a few strong players. Targeted companies have started, and some companies have been able to pass European and American certifications. However, subject to the scale of production, it is difficult to receive orders, and huge investments cannot be converted into outputs.

Another person in the industry stated that it is not possible to enter the mainstream markets in Europe and the United States, and that companies can also obtain revenue through other means. On the one hand, it cooperates with foreign companies to become its OEM supplier, borrows other people's brands, sells its own products, and gradually establishes its own brand. On the other hand, passing the FDA or the EU EDQM certification is itself a “golden signboard” for companies, which can lead to sales in other markets such as Southeast Asia, South America and other countries and regions. In addition, because the WHO recognizes EU certification, it means that companies that have passed EDQM certification have the qualification to participate in international procurement. As we all know, international procurement has many advantages such as stable order quantity and huge amount. Which will benefit a lot.

More business people are concerned about the "Special Implementation Plan for Upgrading the Quality of Pharmaceutical Preparations System" led by the Development and Reform Commission and other departments. This program conveys many exciting information: if the country will support it with special funds, it will support There are 5 demonstration companies for comprehensive R&D and industrialization internationalization platforms, 15 international companies with integrated raw material medicines and preparations, and 15 export preparation and processing companies; if any products have passed cGMP certification, they are expected to be in the provinces. In the centralized bidding and procurement of medicines, it is treated differently in terms of pricing; if the country will also give support in terms of export tax rebates and import tariffs, pharmaceutical companies that have passed foreign cGMP certification and have successfully exported pharmaceutical preparations to international mainstream markets, the export tax rebate rate is expected to increase... ... In response, Yu Mingde, president of the China Association of Pharmaceutical Industry Management, said that the state supports such enterprises in terms of policies and pricing, and encourages pharmaceutical companies to upgrade the quality of pharmaceutical preparations in order to promote the optimization of the pharmaceutical industry structure. “This project will Get approved soon."

An EDQM official once said that due to the differences in Chinese and foreign GMP standards and the higher international GMP standards, some Chinese companies have implemented double quality standards internally to reduce costs. The practice of such companies is actually undermining their own credibility. In this regard, a person in charge of a pharmaceutical company that has passed the EU cGMP certification stated that under the current bidding policy in our country, it is difficult for the medicines produced under the cGMP standard to gain advantages in the provinces' recruitment. There is great hope for differential pricing. “If such drugs can obtain high-quality, high-price treatment in tendering, then the vast domestic market will become a key development goal for the company.”

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It has been an ideal for the Chinese pharmaceutical industry to let formulations go abroad. With the rapid development of the world's generic medicine market and the encouragement of generic drugs by various governments in order to save the cost of medicines, the realization of this ideal by the generic pharmaceutical giant China has become even more urgent. We are very pleased to see that some powerful companies have invested heavily in international certification, and China's pharmaceutical preparations have passed the FDA certification is no longer a myth. However, we are more and more looking forward to the emergence of news that Chinese pharmaceuticals really entered the markets of developed countries with their own brands. There is no doubt that there is still a long way to go to realize this ideal. We have hardware facilities that are in line with international standards. We must also have corresponding talents and management methods. There must also be enterprise decision makers who can afford to stand up to this ideal, and who can tolerate loneliness. They must also have corresponding policy support. . The “Special implementation plan for the upgrade of the quality assurance system for pharmaceutical preparations” led by the Development and Reform Commission and other departments is about to be adopted and will be a solid backing for companies that are striving to achieve their ideals. We believe that Chinese medicine will surely make greater contributions to the health of the people of the world.