Chinese medicine exported by the enemy: high-end hard enemy Europe and the United States | low end than India

Pharmaceutical Network December 29 News Western pharmaceutical preparations global competition as a race, China 'participating' enterprises have improved, the overall competitiveness is not satisfactory .For some well-funded pharmaceutical companies, investment in the sea, mergers and acquisitions after all, an international shortcut.

(The vast majority of Chinese pharmaceutical companies to enter the international market is mainly the main way to trade.If the western pharmaceutical preparations than to participate in the global market competition as a race, European and American pharmaceutical companies, and even Indian pharmaceutical companies, has long run out of a large part of China Medicine calculation has just started. Figure / Visual China)

Chinese medicine Health products Meng Dongping, vice president of the Import and Export Chamber of Commerce, still remembers the embarrassing scene five years ago. In 2012, Meng Dongping led a domestic pharmaceutical company to visit Russia. A Russian merchant complained to her and hoped to import more and more from China Quality drug.

In the same year, there were only a handful of Chinese indigenous medicines on the global pharmaceutical market, and the total number of Chinese pharmaceutical companies applying for the generic drug application (ANDA) was only 11 in 2012. Meng Dongping is no longer worried about being embarrassed when he leads the team again Reproduce.

So far there are more than 80 Chinese preparations enterprise Of the nearly 100 formulations in the European and American markets to achieve sales, has been registered and are registered more than 200 products.

With the frequent encouragement of warm policies for the export of preparations, the voice of China's domestic preparations export has been rising rapidly. However, in the international market competition, Chinese domestic formulation companies are aggressively competing: high-end products compete with European and American enterprises but with low-end products Indian companies, more importantly, their own strength not too hard.

Whether China's domestic preparations can ultimately broaden the global market and out of the quagmire of slow growth will require more tests in order to enhance its success in drug production, innovation and R & D, and mergers and acquisitions.

In the international division of labor, Chinese pharmaceutical companies are at the bottom of the value chain for a long time, consuming domestic energy and making profits in foreign pharmaceutical companies. medicine In the four links of the value chain, the Chinese pharmaceutical companies only have certain advantages in the manufacturing and manufacturing sectors. "This is not a truly internationalization but merely an export of trade," Meng Dongping pointed out.

As a result of the low industry threshold, a large number of enterprises are pouring into each other, a 63% increase in the number of exporters of pharmaceutical products over the seven years from 2009 to 2016. The result is a serious excess capacity for raw material pharmaceuticals, weakened export bargaining power and internal battles in domestic enterprises Outside the fight, the customer bargain.

'A bit like the rare earth industry in the past, their own companies and their own business competition, the market mess in a mess,' said Wang Xuegong, vice chairman of China Association of Pharmaceutical Management said.It is understood that the average profit of China's chemical raw materials exports only 5 %, While the chemical's net profit margin is generally above 30%.

According to the data of China Chamber of Commerce for Import and Export of Medicines and Health Products, compared with about 6% five years ago, the export volume of western medicine is now over 10% of that of pharmaceuticals, but the proportion of APIs still exceeds 80% Group exports more than 600 million U.S. dollars each year, more than 90% contributed by APIs.

Trying to export high value-added preparations has become an option for pharmaceutical companies to break through. Most enterprises preferred developing countries as their first stop. Afterwards, some pharmaceutical companies started to undertake the international contract processing industry, that is, .

To undertake the production of the pharmaceutical companies must meet the requirements of cGMP in Europe and America, which means that time-consuming and costly. "Finance" reporter learned that a preparation plant in order to pass the US Food and Drug Administration (FDA) certification, 5 years to spend Nearly 200000000 yuan.Move to China are mostly some old generic drugs, profit is not high, the market volatility, often facing the risk of price competition and delisting and delisting.

Export Reagents, the Key Opportunities for Chinese Pharmaceutical Enterprises The common name phase of the patent expiration phase and beyond, including the patent over-patenting, the challenge patent and the authorization of the patent during the patent period. For the vast majority of Chinese enterprises, there is currently no challenge patent And the strength of the authorized generic drugs, after the patent expires in the field of generic drugs to apply for or purchase ANDA production license to enter the mainstream market in Europe and America is the reality choice.

In December 2016, at the delivery ceremony of Qilu's first batch of powder preparations for export to the United States, Bao Haizhong, the deputy general manager of Qilu Pharmaceutical Group, took glasses and wiped tears many times, which is "not easy." This is the first time for domestic pharmaceutical companies to achieve cephalosporin injection Powder exports to the United States.

An export preparation from the initial development to the final listing generally go through four or five years, invested millions to tens of millions of dollars, of which need to go through research and development, to confirm the batch and registered batch production, stability and registration of the preparation and reporting, After the approval is also required, including serialization, packaging design, production organization, product release and logistics options and a series of market preparation work.According to Qilu Pharmaceutical International Certification work memories, the company's formulation just export, the largest The difficulty is that foreign countries, especially the regulatory market, have a low level of awareness of Chinese pharmaceutical companies and low levels of 'made in China' brands, which require continuous application and international accreditation, gradually gaining recognition and exporting preparations step by step. Need a process'.

And 'the United States special attention to the quality of the preparation market, once a quality problem, the impact on the market after the enterprise will be very large.' A pharmaceutical company's head of import and export business, "Caijing" reporter said.

From 2009 to 2017, the US FDA issued import warnings to more than 40 Chinese pharmaceutical companies, many of whom are large-scale pharmaceutical companies, especially in recent years, the FDA has taken the monitoring of Chinese APIs and preparations from random inspection to routine inspection. The problem is in the data, including incomplete data, inaccurate data, false report of analysis, record replacement content, duplication of records, date and signature inconsistencies and so on.

The vast majority of Chinese pharmaceutical companies to enter the international market is mainly the main way to trade.If the western pharmaceutical preparations than to participate in the global market competition as a race, European and American pharmaceutical companies, and even India's pharmaceutical companies have long run out of a large fraction of Chinese medicine Calculations just started.

US FDA official website data show that in 2016 the FDA approved 22 ANDA applications from Chinese pharmaceutical companies.

In the first half of 2017, another 18 ANDA symbols were approved, which is still weak compared with the Indian pharmaceutical companies, the champion of generic drugs.

According to a rough estimate, several domestic pharmaceutical companies that really go out have an annual sales volume of more than 200 million U.S. dollars. In contrast, India's third-largest pharmaceutical company has more than 1 billion U.S. dollars in annual sales in the U.S. market .

A pharmaceutical patent expires after a short profit window, Indian companies, local and European generic companies have already filled this up. 'For some patents have a long product, we actually have no chance.' Wang Xue Gong told According to Caijing, "Many Chinese enterprises register only two or three varieties in the United States and it is difficult to form an international sales scale."

Large-scale export preparations is a complex system engineering, the development of foreign generic drugs is different from China, a product life cycle may be short, a generic generic drugs listed 35 years after the general will launch new products, and constantly fill the gap, which is a Continuous dynamic process.Polyprise's international strategy can not be separated from a series of product layout, continuous R & D registration, docking and pioneering capabilities in Europe and the United States market, in line with the standard production sites and many other conditions.

Wang Xue Gong analysis, but fortunately, there will always be some patents expired drugs each year, if these varieties grasped, seize the window to do, there may be a chance to break through; domestic pharmaceutical companies have the advantages of APIs, for some special large amount of cost composition High product, you can take advantage of the integrated raw material preparation advantages.

Like India's pharmaceutical companies in that year, several fast-growing exporters of generic pharmaceuticals began to accelerate internationalization through mergers and acquisitions, which is one of the effective ways for domestic pharmaceutical companies to go out in recent years.

Wang Yao, vice president of Fosun Pharma, and Jason Zhang, managing director of IFSHI's international investment and business development, both said that through mergers and acquisitions, companies not only acquire overseas technologies, but also gain global sales network and benefit their own products With mergers and acquisitions products, direct access to the global network to achieve the layout of business overseas, but also can help upgrade the domestic business.

In 2016, the number of M & A deals for medium and large-sized pharmaceutical companies reached 25 and the total amount of M & A transactions reached 5.5 billion U.S. dollars. For example, Luye Pharma acquired the transdermal drug delivery system business of Swiss company Acino for 245 million euros, In the same year, Welfare Pharmaceutical acquired Epic Pharma in the United States and is expected to have more than 100 ANDA approval in the future. In 2017, Fosun Pharma acquired India for 1.091 billion U.S. dollars. A 74% stake in pharmaceutical company Gland Pharma has set a record for overseas mergers and acquisitions by Chinese pharmaceutical companies.

Investment, M & A is not as simple as buying and buying.With the acquisition of the Swiss leaf Acne Pharmaceutical transcutaneous drug business, for example, the acquisition is a tender project, green leaves in the early due diligence to fully assess its potential business risk , And tap the business value of the target company, focusing on how the underlying company can contribute to its future, bring products and technologies to China, and generate more business and synergies.

After the merger and acquisition of the integration is very important, a lot of mergers and acquisitions, acquisitions completed and found it difficult to integrate in the commercial negotiation phase, there needs to be enough team docking. "Green leaf Vice President Jiang Hua after summing up experience analysis.

If enterprises do not have a formed internationalization strategy, blind mergers and acquisitions will be risky. "Looking at a foreign company depends on its financial statements but also on whether the enterprises really understand the business models and operating rules in foreign markets," said Wang Xuegong.

In recent years, large pharmaceutical companies at home and abroad also try a new road with small and medium-sized innovative drug companies.Philips Pharmaceutical Co., Ltd. Greater China Wu Xiaobin, president once said that multinational pharmaceutical companies and innovative small and medium-sized drug companies, to carry out various forms of drugs R & D cooperation, 'encourage innovative drug companies to invest, build, give small businesses freedom'.

From imitation, imitation and innovation to innovative drugs, ambitious Chinese enterprises.At present, there are dozens of innovative drugs approved by the US FDA to enter the clinical research phase.However, for Chinese pharmaceutical companies, it is in a painful period.Some pharmaceutical companies In terms of innovative drugs and acquisitions have not seen any return, but in order to upgrade the industry and strategic adjustment, forced to stop cruelly down orders for generic drugs and APIs.

With different standards, it is the biggest predicament facing the export of Chinese preparations in the past, and many of the policies that encourage the internationalization of preparations have been released continuously and will probably improve.

China's standard-setting to consider more than the regional market technical level of production, pharmaceutical testing and economic development capacity, relative to foreign countries, domestic product quality standards in the development process is relatively low.Lv Ye Pharmaceutical chairman Liu Dian-bo pointedly pointed out that China over the past 20 years is a In a special period, people in the industry are kind of speculative. Under such circumstances, no one really contributes to international standards.

The domestic GMP is also formulated with reference to the US cGMP, but in the implementation level, most pharmaceutical companies think GMP is too much trouble, not strictly in accordance with the GMP to manage, the regulatory authorities check is not strict.CICC Third Hospital Li Yingui, an associate dean, recalled that four years ago, when the companies began to make the export of the U.S. preparations and applied for the 'passport' in the U.S. market, the FDA scrutinized the cGMP strictly in accordance with the standards of the cGMP. Many application applications fell to this level.

At that time, the CFDA regulatory system, especially product approval, standard management, inspection and certification and other aspects has not been in line with international standards, resulting in the GMP standard can not be recognized by other countries. A pharmaceutical enterprises want to expand the international market , Had to re-do clinical trials, all the approval documents have to redo .2016, CFDA released on the priority review and approval of the scope of the policy, clearly in China with the same production line in the United States, the European Union drug approval agencies simultaneously apply for listing And passed the application for on-site inspection of drug registration, priority review.

As the Chinese market itself needs such an upgrade, as Liu Dianbo said, if the Chinese market is also regarded as a domestic market, it is Out. According to the IMS report, in 2014, the global pharmaceutical market was 976.1 billion U.S. dollars, of which the Chinese pharmaceutical market accounted for 11% of the total, while the U.S. market accounts for 39%.

In June 2017, China became an official member of the ICH, and companies will be able to declare to regulators in multiple countries and regions on the same technical requirements, eliminating the need for two more identical clinical trials.

China has long acceded to the WTO and all countries will have some protectionism in the pharmaceutical trade but they will only be able to raise barriers to entry as long as their standards are consistent with their standards in clinical trials and manufacturing, Will be treated fairly. 'Jiang Hua said.

On October 8, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the "Notice on Deepening the Reform of the Examination and Approval System for Examination and Encouragement of Pharmaceutical Products medical instruments Innovative opinions, "put forward 36 reform measures, clearly pointed out that the European and American varieties will be accredited as a priority review; In addition, also provides for registration of generic drugs to meet international standards can be exempted from some of the clinical trials, bidding, a separate quality classification criteria , The protection of intellectual property and so on.

However, the heating up of this policy needs to be more delicate and effective for pharmaceutical companies on the internationalization path. "Many policies have been issued at the national level for the entire industry, and both the guiding principles and the framework are positive, but concrete implementation is still needed now Otherwise, companies do not know how to do it, regulators will not know how to regulate. "An industry told the" Financial "reporter.

Pharmaceutical industry is affected by the policy and regulation of larger industries. 'Institutional reform can release productivity.' Bory biological senior vice president Wang Zhaoyuan interview with the "Financial News" analysis, the real strength of the enterprise is very sensitive to favorable policies, As long as the policy is slightly supported, companies can take advantage of the momentum.

It is still some time before spring exports of Chinese preparations come, but at least the wind has blown.