The development level of domestic biopharmaceuticals needs to be improved urgently

As the country's seven strategic emerging industries in the key areas of development of biological medicine, has been repeatedly included in the state to encourage and support the policy range. It was recently learned that the "12th Five-Year Plan" for the bio-industry has been submitted to the State Council and may be released in November, which is expected to become another important engine for the development of bio-medicine.

Based on the understanding of policy researchers, top management, investment institutions and other parties, although China's bio-pharmaceutical industry has many “auras” in its head, it is still insufficient in innovation, examination and approval, and international cooperation, especially for local governments that have plans to “go to sea”. For enterprises, there are many "homework" and "tuition fees" that need to be prepared.

The policy level continues to exert force The "Twelfth Five-year Development Plan for the pharmaceutical industry" released earlier this year shows that more than 100 biotechnology drugs are currently on the market, and more than 400 varieties may complete the clinical research on the market. Of the top 20 best-selling drugs in the world, 7 are biotechnological drugs. Biotechnology drug revenue has maintained a growth rate of more than 15% for many years, which is more than double the growth rate of all drug sales revenue. It is estimated that by 2020, global biotech drugs will account for more than one-third of the total pharmaceutical sales revenue.

The former U.S. ambassador to China, Hung Bopei, frankly stated that the current global economy is not optimistic and that “liability,” “transition,” and “concerns” have frequently appeared. Bio-pharmaceutical industry, as an industry that helps improve human life, will undoubtedly become the focus of the future. The field of development. Under the background of the increasing demand for medical services driven by the aging of China, the prospects for joint research and cooperation between China and the United States are boundless.

From the perspective of domestic development, the policy side continues to promote the development of the biopharmaceutical industry, including the major science and technology major projects of "major new drug creation", the national 863 plan, the "National Medium and Long-term Scientific and Technological Development Plan Outline (2006-2020)", and the "Pharmaceutical Industry". The "Twelfth Five-Year Plan" and the "Twelfth Five-Year Plan for Biotechnology Development" etc. have all incorporated biomedicine into important areas of development without exception.

Li Qing, director of the Center for Medical and Health Science and Technology Development of the Ministry of Health, stated that the 12th Five-Year Plan has completed 209 research projects in two batches. The central government has approved funds of 4.564 billion yuan. The proportion of hospitals, universities, research institutes, and enterprises was 8.97%, 19.58%, 17.5%, and 53.94%, respectively. The highest percentage of the country's allocated fees was allocated to 50.41%, or about 2.3 billion yuan.

Li Qing also disclosed that the “12th Five-Year Plan for Biological Industry” led by the National Development and Reform Commission focuses on seven fields: biomedicine, biomedical engineering, bio-agriculture, bio-manufacturing, bio-energy, bio-environmental protection, and biological services. Do some noun explanations and other supplementary work.

Urgently improving the level of drug development According to Tao Jianhong, deputy director of the Southern Medical Economic Research Institute, the structure of China's biopharmaceutical industry is pyramidal, with 4 large companies including China National Biotechnology Corporation at the top and more than 100 medium-sized companies in the middle. At the bottom, most of them are small-scale enterprises. They mainly produce ordinary vaccines, extraction products, or recombinant early biosimilars, including human blood proteins, recombinant interferons, and erythropoietin (EPO).

From the perspective of market distribution, large varieties account for about 70% of the top 500 sales. Of the 13 categories of 25 genetically engineered drugs and genetically engineered vaccines of the 382 specifications that have been approved for listing in China, only 6 types, 9 types of 21 products are original, and the rest belong to imitation.

Generic drugs refer to the same kind of imitation products as the drug in terms of dose, safety and efficacy, quality, effect and indication. By reducing the cost of original research and development of biopharmaceuticals, patients can drastically reduce drug costs. The demand for generic drugs is growing.

According to Evaluate Pharm's prediction, the global biosimilar market will grow to US$10 billion by 2015 and grow to US$20 billion by 2020. In addition, according to Chugai Pharmaceutical's forecast, the U.S. is still the largest market among the 7 countries with the largest biomedical generic drugs market, and it is expected to reach 9 billion U.S. dollars by 2013.

Merck, Eli Lilly, Pfizer, GSK, Bayer and other multinational pharmaceutical giants are actively preparing for biosimilars. In contrast, China has lagged far behind the developed countries in the speed of innovation of original research drugs, and the speed of R&D of generic drugs is not as good as India and Brazil.

In response, Sun Xianze, the deputy director of the State Food and Drug Administration, recently stated that relevant departments support the use of laws and regulations and technical standards, and use effective policies to improve the level of drug research and development in China. Companies with scientific research strength have increased investment in research and development of new drugs and new technologies. At the same time, improve the review and approval mechanism, establish research institutions and registered species verification and clinical trial institutions hierarchical management.

The "sea" companies need to take care of both inside and outside a vice president of a domestic pharmaceutical group that is listed in Singapore and has special protection for new drugs. He said that after contacting a large number of overseas companies, he found that the other party was most concerned with "integrity, product quality, Cost control, team communication without barriers, and in fact, many listed companies are often thundering and raining, or faced with the company's financial costs and shareholder pressures after expanding into the market or capital mergers and acquisitions.

Han Liling, deputy general manager of Fosun Pharma's International Department, said that at present, “Made in China” is often affixed with a low-end image tag, but the pharmaceutical market needs to be high, sophisticated and sharp, and the Chinese pharmaceutical industry is still quite far from this goal. In the course of internationalization, there is still a need to pay "tuition fees."

He Meijian, director of consulting at Goldman Sachs Investment Group, pointed out that overseas markets place great emphasis on "compliance", such as accounting and marketing models. This is the first "internal work" that Chinese companies must cultivate in order to "go to sea". In addition, the success of cooperation with overseas companies depends on whether the two parties have the same goals, the controllability of the planned projects, the stability of the management, and whether they can respond flexibly to market needs.

“So, not every company is suitable to become a multinational pharmaceutical company, and the key lies in the strategic positioning of the company. Because apart from product quality being the most basic hardware, what proportion of capital financing is the financial cost, in exchange for the company? Whether the short-term can make up for this difference or generate expected income, etc., all need to be considered in detail and calculate a general ledger.” The above-mentioned vice president of the pharmaceutical group stated that it is worth mentioning that China's pharmaceutical innovation and distribution experience cannot be replicated globally. "We must abide by the "rules of the game" in different regions, and it will be very difficult to gain recognition in the international market.