Bio-pharmaceuticals Listed in the Strategic Emerging Industry, Guangdong, Grab the Twelfth Five-Year High

Business News Agency September 16th Although the national "12th Five-Year Plan" of the biomedical industry has not yet officially unveiled its veil, Guangdong has begun a tight deployment to seize the future high ground. Recently, the reporter learned from the “Seminar on Promoting Independent Innovation in the Bio-pharmaceutical Industry” that Guangdong has included bio-pharmaceuticals as one of the strategic development industries. The goal is to transform from a pharmaceutical province to a pharmaceutical province.

â—Ž Dynamic Guangdong first to include biopharmaceuticals in strategic emerging industries

In August this year, it was reported that the "12th Five-Year Plan" biopharmaceutical promotion plan will be introduced in late August, and the "12th Five-Year Plan" of biomedicine has determined the focus of biomedical development, including genetic drugs, protein drugs, and monoclonal antibodies. Cloning drugs, therapeutic vaccines, small molecule chemical drugs, etc.

At the same time, experts who participated in the formulation of the “Twelfth Five-Year” implementation plan for major national science and technology major projects for major new drugs revealed that the state will provide more than 12 billion yuan to support the creation of major new drugs. On average, each new drug may receive 5 million to 10 million yuan. Project funding.

“In terms of the internationalization of new drugs, we have now fallen behind India.” Professor Wu Chuanbin, associate dean of the School of Pharmacy of Sun Yat-sen University and director of the Innovative Pharmaceutical Preparation Engineering Center of Colleges and Universities of Guangdong Province, said that India has now entered many innovative products in Europe and the United States. Market, and gradually reduce the production and export of low-profit bulk drugs. "This may be related to India's policy support for the pharmaceutical industry and industry development strategies."

Wu Chuanbin said that although the total export of low-end bulk drugs and intermediates in China has increased in recent years and may exceed India, the export model for high-pollution, low-profit, low-end bulk drugs and intermediates is developing in China. The green economic development strategy advocated at present and the development direction of the pharmaceutical industry in developed countries do not coincide. Therefore, the promotion of research and development of high-end products with high profits and low pollution conforms to the development direction of China's modern economy and the development trend of the modern pharmaceutical industry.

Obviously, China’s biopharmaceuticals need to be independent innovations, and the space for this market is also huge. According to foreign experience, the patent period of innovative drugs is generally 20 years, and the exclusive market is no more than 10 years. However, these new drugs cost 10 billion US dollars and may cost 1 billion US dollars a year. Experts point out that good innovative medicines can even be returned in as little as one or two years, which is truly “high risk, high input, and high returns”.

Therefore, although the national biomedical industry revitalization plan has not yet been introduced, various localities have already begun to intensify the deployment of the biomedical industry. Governments such as Jiangsu, Shanghai, Beijing and Sichuan have incorporated biopharmaceuticals into the emerging industries that are being implemented. In the plan, Guangdong is not far behind.

In the "Seminar on Promoting Independent Innovation in the Biomedical Industry" held on September 2, the Guangdong Food and Drug Administration Director Chen Yuansheng disclosed that in this year's Guangdong Provincial Government's 500 Top Modern Industry Projects issued by the provincial government, strategic emerging industries have Of the 103 items, 16 of them are biomedical projects. Biopharmaceuticals have also been included in the 11 strategic emerging industries that are under development and are being actively nurtured.

â—Ž Status quo The third core competitiveness of pharmaceutical industry needs to be improved urgently

In fact, Guangdong has always been a major province of medicine, and it ranks among the top in terms of the total output value of the pharmaceutical industry, industrialization, and marketization.

According to the annual statistics report of the State Statistics Bureau and SFDA, the total value of the pharmaceutical industry in Guangdong Province is 7.34%, ranking third, second only to Shandong and Jiangsu. In 2009, the province's pharmaceutical industry output value was 73.772 billion yuan, an increase of 19.39% over 2008. From the point of view of the output value of each sub-sector, the output value of Guangdong Province in the field of medical devices and biological products is higher than the national average.

With the official launch of the National "Eleventh Five-Year Plan" major scientific and technological project --- "a major new drug creation" project, China's emphasis on innovative drugs has entered an unprecedented period. However, Chen Yuansheng, director of the Guangdong Provincial Food and Drug Administration, said that currently the Guangdong biopharmaceutical industry still has issues such as low product technology content, aging of product varieties, and technological innovation and technology upgrades have not yet become the main forces to promote industrial growth.

Professor Su Weiwei, director of the Center for Innovative Chinese Medicine Research and Development and Technical Service in South China and Guangzhou Modern Chinese Medicine Quality Research and Development Center and professor of doctoral students at Sun Yat-sen University, also believes that Guangdong Province has a certain overall advantage in terms of asset size, industrialization, and marketization in the pharmaceutical industry. The main economic indicators are among the leading countries in the country, and the medical economy once ranked first in the country.

However, in recent years, the pharmaceutical industry in Jiangsu, Zhejiang, and Shanghai has developed strongly and competes with Guangdong Province in terms of products, technology, talents, capital, and markets. The status of Guangdong's pharmaceutical economy in the country is declining, and it is facing slow progress. Retreat, not retreat into a powerful challenge.

Although some of Guangdong's advantageous varieties have a certain brand influence, the market size is still small and has not yet become a leading brand in the market. It lacks a large batch of products with annual sales of more than RMB 500 million.” Su Weiwei analyzed that Guangdong Due to the lack of product renewal and lack of follow-up products, the competitive advantage of the pharmaceutical industry has declined. There is a problem that the varieties are aging and the new products are not competitive.

â—Ž Problems Pharmaceutical companies lack of innovation

"The key lies in the lack of innovation capability of enterprises, and the lack of innovation in the research and development of innovative drugs, leading to a shortage of innovative drugs." Su Weiwei said that Guangdong is now facing more difficulties in the development of innovative drugs, investment and financing channels, innovation systems need to be strengthened and improved, Regional decline in attractiveness, the introduction and training of high-end talent and other issues.

It is understood that in recent years, the global new drug research and development takes an average of 10-15 years, with an average cost of over US$1 billion, and the global pharmaceutical R&D investment has been kept at more than 15% of sales revenue, but the number of listed innovative drugs has dropped to With the lowest level of history, the difficulty and risk of new drug development are increasing. This has led to a poor investment and financing environment for innovative drugs, lack of external investment interest, and insufficient capital input. In China, due to underdeveloped capital markets, the lack of funding for new drug development is even greater.

In the past, Guangdong was mainly a labor-intensive economy. The pharmaceutical industry mostly produced traditional Chinese medicines and generic drugs, and less developed new drugs. With the economic transformation of Guangdong, it is bound to embark on the road of biomedical innovation. However, in addition to funding issues, currently, Guangdong’s innovative drug research and development forces are also too fragmented, not only lacking a number of national drug R&D institutions, but also the capability of innovative R&D and industrialization of basic R&D institutions to be improved. Pharmaceutical companies have not yet become R&D. The main body and its R&D system have yet to be further developed and improved.

"We really do not have many new drugs for innovative compounds from the source, and we have no innovations that have entered the mainstream market in Europe and the United States." Wu Chuanbin said that this situation is not only true in Guangdong, there are no intellectual property restrictions before entering the WTO and drugs can be copied. We have already copied almost the same, and have also established a more comprehensive generic drug R&D and production system.

However, simple imitation also makes domestic new drug research and development lack the ability to create. "Don't say the key technology, only the capital, the entire 'Twelfth Five-Year' investment of less than 20 billion yuan, if calculated according to the international new brand new drug R & D expenses, even if all The research and development of new drugs for this type of internationally recognized innovative compound can only be made in several ways, but not all can be successful,” Wu Chuanbin said.

â—Ž Countermeasures The government increased industrial investment to speed up the integration of new drug creation resources

"The most important thing is for the government to invest in and guide the integration of resources." Su Weiwei said that in the face of opportunities and challenges, Guangdong urgently needs to increase government investment, establish new innovation systems and mechanisms, and integrate various existing research institutes and research institutes. Resources, attracting first-rate professionals at home and abroad, and building an internationally-oriented platform for innovative drug research and development and transformation, accelerating the pace of research, development, and launch of innovative drugs.

Su Weiwei believes that the government's investment needs to be carried out in two aspects: First, investment in capital. Considering the current investment and financing environment for innovative drugs, the government needs to provide more funds to fund innovative drug R&D projects, finance the introduction of high-end talents, and team building in the absence of external capital inflows; on the other hand, it is policy. On the guidance and input. The government needs to provide some new policies, create better innovative drug research and development, industrialization environment, attract high-end talents to join, and attract the injection of R&D strength of international pharmaceutical companies.

"In fact, the strongest R&D capability in foreign countries is often universities and small companies. Big companies do not rely on their own innovations, but rather buy new drugs after they become relatively mature." Su Weiwei said that due to institutional reasons, China's current level of research and development In universities and colleges, they are better than businesses. The ideal model is for scientific research institutes to do preliminary basic research and enterprises to do later development. Guangdong pharmaceutical companies have not yet become the main body of innovative drug research and development, and existing universities, research institutes and enterprises have not yet formed a "joint force." The government should also guide the further integration of the existing R&D forces for innovative drugs, strengthen the construction of "biological islands," and form a relatively complete innovation system of "production-study-research cooperation."

Regarding the introduction and training of high-end talents, Su Weiwei suggested that the government should strengthen the funding of high-end talents and the tilt of policies to attract more high-end talents; on the other hand, it should increase funding for the cultivation of pharmaceutical talents, while universities Strengthen the construction of such disciplines.

“Guangdong Biopharmaceutical's independent innovation must be connected with major special projects to obtain more preferential policies. We hope that Guangdong can make breakthroughs in vaccines and antibody drugs.” For the direction of the development of Guangdong biopharmaceutical industry, the National Food and Drug Administration Bureau of Pharmaceutical Examiner Yang Wei suggested that Guangdong, as a large pharmaceutical province, can focus on secondary development, especially branded Chinese medicine. “The definition of a major national new drug creation project on secondary development includes the definition of effective substances, the clearness of the mechanism of action, and the improvement of dosage forms. And so on, what level of secondary development to achieve and what goals to achieve must have a certain design."

â–  Measures

Major projects have been supported by the modernization of traditional Chinese medicine

According to Chen Yuansheng, the Guangdong Food and Drug Administration has initially selected a number of biopharmaceutical companies through a thorough investigation and on-site investigations. It intends to promote the self-innovation backbone enterprises of the biomedical industry as a province, and increase support to drive the province’s biological resources. The pharmaceutical industry has increased its level of independent innovation.

In the first half of this year, the Guangdong Provincial Government approved the establishment of a joint meeting of the province's independent innovation work in the biomedical industry, clearly stipulating that the Provincial Bureau of Food and Drug Administration should be the lead unit of the joint conference. Comprehensive coordination includes the National Development and Reform Commission, the Economic and Credit Commission, the Science and Technology Department, the Department of Finance, and the People's Insurance Agency. The member agencies such as the Health Department and the State-owned Assets Supervision and Administration Commission all promoted the independent innovation of the biomedical industry to achieve new breakthroughs and new developments.

"Promoting independent innovation in the biomedical industry is a key task for the Guangdong Province Food and Drug Administration this year and in the coming years." Chen Yuansheng said that the Guangdong Food and Drug Administration has adopted policy initiatives such as optimizing the drug registration system to encourage innovation and development. With the innovative drug registration and inspection procedures, the Provincial Food and Drug Administration has supported the province's innovative drug research and development and encouraged enterprises to implement early intervention, timely guidance, follow-up inspection, and accelerated approval. Transplantation of product technology led to the integration of pharmaceutical resources from small-scale and poor-quality enterprises to large-scale and high-quality enterprises.

“The new registration laws and regulations more encourage innovation, pay more attention to industrialization, increase the technical threshold of generic drugs, and play a positive role in promoting the innovation of Chinese pharmaceutical companies, especially for those of us who focus on R&D and value science and technology. It is a good thing.” The person in charge of science and technology R&D of Guangzhou Baiyunshan Pharmaceutical General Factory under the GP Group said that the “imitation” of new drugs in terms of raw materials and preparations is the current mainstream of independent innovation of drug companies. There is almost no profit for the basic imitation medicines. Although there is no innovative medicine for the "new dosage form" of drugs, the investment and risk of the new dosage form are much smaller. The cost is only 1/3 or less of the new medicine, and the cost is several million RMB. Can do it.

In fact, Guangzhou Baiyunshan Pharmaceutical General Factory successfully cultivated China's first and the world’s only semi-synthetic cephalosporin—Ceprothione which has been successfully developed by Chinese independent innovation and has a new structure. "National Technological Invention Second Prize." The new compound ceftazidime, currently being researched, was also granted US patent authorization and received strong support from the Ministry of Science and Technology. However, despite major breakthroughs in innovative drug development at the source, they have not given up on the “innovation” of new drug development for formulation innovation, but instead have made it a key focus of their work.

The entire Guangdong Province also regards such innovation as a breakthrough point. Chen Yuansheng disclosed that the provincial food and drug supervision department will work hard to strengthen industry guidance, transform innovation results, and plan overall industrial development on the platform of the Provincial Joint Meeting for Independent Innovation of the Biomedical Industry. "Guangdong will focus on the development of modernization of traditional Chinese medicine and new drug preparations, selectively develop chemical raw material drugs, vigorously support the high-tech industries of life sciences, biomedicine and biomedical engineering, giving priority to the development of biopharmaceuticals with independent intellectual property rights and broad market prospects. , Strive to form new breakthroughs in genetic engineering, antibody drugs, etc."