How to develop the bio-pharmaceutical industry in Dawan District of Guangdong, Hong Kong and Macao, policy innovation, talents and capital are indispensable

In July 2017, with Hong Kong, Macao and Guangdong jointly signing the “Framework Agreement for Deepening Guangdong-Hong Kong-Macao Cooperation & Promoting the Construction of the Dawan District”, Guangdong, Hong Kong and Macao Dawan District will become a demonstration zone for in-depth cooperation between the Mainland and Hong Kong and Macao. A quality life circle for swimming. Under the development goal of health and health, the demonstration area with 9+2 cities in Guangdong, Hong Kong and Macao as the core has become another highland of medical innovation.

After incorporating the national development strategy in Dawan District of Guangdong, Hong Kong and Macau, Zhongshan City, as a member of the “9+2” urban agglomeration of Guangdong, Hong Kong and Macau, has taken the lead in a series of innovative explorations in the health industry and medical services.

Recently, the 13th Health and Development Zhongshan Forum and the 2018 Wu Jieping Medical Awards Conference were held in Zhongshan, Guangdong. Han Qide, Vice Chairman of the 12th National Committee of the Chinese People's Political Consultative Conference, Bai Chunli, President of the Chinese Academy of Sciences, Academician of the Chinese Academy of Sciences, and President of the West Lake University, Shi Yigong In 2003, Nobel Prize-winning chemist Peter Agret and other dozens of top experts and entrepreneurs in the medical and medical industries gathered at home and abroad to explore the current development of urban medical and biomedical industries.

The 13th Health and Development Zhongshan Forum, 2018 Wu Jieping Medical Awards Presentation Ceremony

The status quo of developing medical and health industry in Zhongshan area

Zhongshan has a total population of 18 million square kilometers and a total population of 3.26 million. It has created the sixth largest economic aggregate in the province with a land area of ​​1% in Guangdong Province. In 2018, GDP will exceed 350 billion yuan, and per capita GDP will exceed 100,000 yuan. The quality and scale of urban development are among the highest in Guangdong Province.

Zhongshan City has formed a strategic emerging industry such as high-end equipment manufacturing, health technology, and new-generation information technology, forming 38 national-level industrial bases, especially the development of health technology industry in the forefront of urban clusters in Guangdong, Hong Kong and Macau. .

Zhongshan Municipal Party Committee Deputy Secretary and Mayor Wei Weihan pointed out that Zhongshan City has both state-level industrial parks, state-level innovative parks, and a comprehensive experimental zone for national biomedical industrial clusters.

At the same time, it includes the health base, Sino-German Biomedical Industrial Park, Cuiheng New District Biomedical Science and Technology Park and South China Modern Chinese Medicine City and other health science and technology industry development carriers. It is estimated that the output value of the health technology industry in the city will reach nearly 90 billion this year.

There are many pain points in the biomedical industry, and pharmaceutical production needs multi-party cooperation.

As an important development city in the Dawan District, the Standing Committee of the Zhongshan Municipal Committee, the Secretary of the Party Working Committee of the Torch District, and the Secretary of the Party Working Committee of the Cuiheng New District, Hou Yubin, admitted that in terms of the development of the biomedical industry, Zhongshan City still “has encountered some difficulties”:

First, there is no big institution, and there are still insufficient scientific and technological research and development capabilities;

Second, there are not many innovative backbone enterprises;

Third, the work of science and technology finance needs to be further strengthened;

Fourth, the urban infrastructure construction needs further improvement.

For the health care industry in the whole country, the shortcomings of insufficient independent innovation ability are widespread. Pan Honghui, president of Zhongshan Kangtian Yihe Biotechnology Co., Ltd. believes that China's biomedical production currently faces three major pain points:

First, there are only 15 biochemical biopharmaceuticals produced in the industry, and most companies have no experience in producing biomedicine;

Second, the experience of the quality system, starting from October of this year, China's biomedicine has become the focus of the US FDA's naming needs to be reviewed, including quality and data integrity. In addition to China, the same "treatment" is in India;

Third, employees of Chinese biopharmaceutical manufacturing companies lack production experience, and the average production line has less than two years of experience.

People's health requires that drugs are safe and effective, and new drugs are constantly on the market to treat diseases that cannot be cured or prevented by current drugs. This is both a driving force and a heavy pressure for drug regulatory authorities and the pharmaceutical industry. In the face of pain points and stress, learning from foreign experience and introducing advanced foreign technology has become the best way to develop biomedicine.

Zhongshan's industrial strength is strong, and the health care industry has become the three key development sectors of Zhongshan. The government is actively building an ecosystem of ecosystem services based on CRO, CMO, CDMO, CSO and CRAO.

At the meeting, the world's top 500 companies, Thermo Fisher Scientific, also signed a cooperation agreement with the Zhongshan Torch Development Zone Management Committee to jointly open an open laboratory with the Zhongshan Torch Development Zone and the National Health Base, and intend to bring the biopharmaceutical CDMO, The MO platform was introduced to Zhongshan.

Xu Xingguo, Senior Director of Strategic Clients at Thermo Fisher Scientific in China, said: "The company has a lot of developments in bio-manufacturing solutions, laboratory products and environmental monitoring with the Zhongshan Torch Development Zone and the National Health Base. The second communication, in this strategic cooperation agreement, the two sides will have comprehensive cooperation in all aspects of shared laboratory construction, biosafety, CDMO platform construction, talent training, environmental and food safety rapid monitoring solutions."

Zhongshan Torch Smart Health Town

At the beginning of the 21st century, the United States introduced "Quality from Design (QbD)". The implementation of QbD can reduce the regulatory burden, facilitate continuous production improvement, and reduce the chances of deviations or product scrapping due to lack of design space and the need to adhere to a narrow control range. The US pharmaceutical industry has made progress in implementing QbD, and some new drug declarations have been implemented in accordance with QbD.

Pan Honghui said that the country can use QbD principles to conduct research and development of new drugs that can be marketed. It can use science to ensure the quality of products and drugs, and reduce their risks, so that the development and production of drugs can be better and better. The needs of people's patients for the safety, efficacy and needs of medicines. At present, Zhongshan Kangtian Yihe Biotechnology Co., Ltd. has signed a cooperation agreement with the German Sartorius Group to cooperate with the QbD Application Center based on the complete QbD service package provided by Sartorius.

For the development of the city, Zhou Muzhi, a professor from the Tokyo University of Economics in Japan, mentioned the term “radiation”. “'radiation power' refers to the ability of a certain industrial development in the city to serve outside the city.” He pointed out that in the future, how to transform the hospital-centered medical system into a personal-centered medical system. It is a question worthy of consideration in Zhongshan.

Chen Xiaojing, head of Novartis Pharmaceuticals, is particularly concerned about Zhongshan's innovative ecological environment: “After the improvement of Zhongshan's innovative ecological environment, I believe that more and more multinational companies will be willing to invest in Zhongshan and bring innovative products and technologies here. With the continuous deepening of the construction of Guangdong, Hong Kong and Macao Dawan District, more and more enterprises will pay attention to Zhongshan, and will also drive more and more innovative resources into Zhongshan."

The MAH system brings opportunities, stimulates innovation and accelerates the transformation of results

At this meeting, the Marketing Authorization Holder (hereinafter referred to as the “MAH System”) is also one of the focuses of discussions among experts and scholars.

On October 23, 2017, the State Food and Drug Administration (hereinafter referred to as CFDA) announced the "Amendment of the Drug Administration Law of the People's Republic of China (Draft for Comment Draft)". The first amendment was added after the general rule. Article 5: “The State implements the system of holders of drug listing licenses, and the holders of drug marketing licenses shall bear legal responsibility for the safety, effectiveness and quality of drugs.”

This means that the MAH system, which has been piloted in ten provinces and cities nationwide since November 2015, has finally released a signal that will be implemented nationwide.

Compared with the previous model of binding of pharmaceutical marketing licenses and production licenses, the R&D enthusiasm of drug research and development institutions, scientific researchers and pharmaceutical manufacturers has been further mobilized. The separation of marketing licenses and production licenses has provided huge opportunities for CMO/CDMO enterprises. Business opportunity.

Gao Huijun, deputy secretary-general of the Shanghai Food and Drug Safety Research Association, said that the national MAH pilot principle is to encourage and innovate, encourage enterprises to strengthen and unite, and then use this method to accelerate the transformation of results.

In May 2016, the State Council issued the MAH pilot program and implemented pilot projects in 10 provinces and cities including Beijing, Shanghai, Shandong and Guangdong. In the pilot process, it is necessary to dock international rules, and then carry out the entire experimental MAH system with the concept of copying and promotion.

Taking Shanghai as an example, Shanghai must establish an insurance system and establish a risk relief fund system, which stipulates that the principle of trustee enterprises is in this city, and it is allowed to optimize production resource allocation in 10 pilot areas.

At the government level, the Zhangjiang Management Committee invested 50 million yuan to set up risk relief funds. "When there is a problem, it can pay first." Gao Huijun stressed that companies must purchase corresponding commercial insurance to ensure security during the development process.

At the level of approval, the Food and Drug Administration is trying to open a green channel, and then to guide the company in detail, especially in the process of allowing the clinical trial application or marketing approval to change the identity of the holder before and after approval. We are involved in the enthusiasm of piloting these people.

“The Food and Drug Administration has also proposed a number of incentive policies to change production companies. As long as the company supplements the information, the application process can be changed. The application process is also quite simplified. Shanghai is in the pilot process, in the design of the program, and in the corresponding supporting facilities. I tried some work on it."

The pilot MAH system in Shanghai has been fruitful for more than two years. According to Gao Huijun, there are more than 100 applications for participation in 39 pilot projects, including 59 drug varieties, 32 of which are new innovative drugs worldwide, including Ding Ding Pharmaceutical, Baekje Shenzhou, Hualing Pharmaceutical and other enterprises. The new drug relies on the preparation of outsourced biological product samples to accelerate the process of research and development.

"From the product point of view, it is also true that the MAH pilot wants to promote the development of innovative drugs. 71% of the application holders are R&D institutions, which is how we have thought of the R&D achievements of R&D institutions. The results can be effectively industrialized."

In general, the impact of MAH on the biopharmaceutical industry is:

1. Conducive to pharmaceutical companies to carry out foundry services, CMO business is developing rapidly;

2. Realizing the integration of resources within the enterprise, and the effective promotion of professional scale is more conducive to the development of R&D enterprises without production resources;

3. Realize the research and development dividends of universities and R&D enterprises;

4. The regulatory system changes and risks are avoided. New drug research and development, clinical approval, new drug listing approval in the national bureau, production and market supervision in the provincial bureau and local. Two whole process supervisions have enabled drug safety risks to be effectively controlled.

From the experience of Shanghai, the MAH system is a huge opportunity for the urban biomedical industry cluster. Hou Yubin said: "In the face of good opportunities for the construction of Guangdong, Hong Kong and Macao Dawan District, and facing the good opportunities of the national MAH regulatory policy and the reform of the irrigation system, Zhongshan City will seize this rare opportunity to improve our policies and strengthen our Services, as well as building our innovative environment to support the rapid development of the health technology industry in Zhongshan."

The government supports the creation of a biomedical systemized industrial service ecosystem

Hou Yubin stressed: "In the face of good opportunities for the construction of Guangdong, Hong Kong and Macao Dawan District, and also facing the good opportunities for the reform of the national MAH regulatory policy and regulatory system, Zhongshan City will seize the opportunity to improve through policy and strengthen service areas. Innovative environment construction to support the rapid development of the health technology industry."

In terms of the service system, in addition to the vigorous construction of the bio-systematic industrial service ecosystem of CRO, CMO, CDMO, CSO, CRAO to enhance the development of Zhongshan's service industry, it also promoted the Zhongshan Laboratory of Guangdong Provincial Port Drug Inspection Institute. The construction of the South China Branch of the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences has promoted the project of the Innovation Center of the University of Hong Kong and the Guangdong Pharmaceutical University. This series of actions will continue to enhance the innovative environment for the development of the health industry in Zhongshan.

During the conference, 17 high-quality health medicine projects from the University of Hong Kong and Guangdong Pharmaceutical University completed on-site signing, including in vitro diagnostic reagent product industrialization, antibody-conjugated drug development, human YB1 cancer immunotherapy program, polymer-based nano silver The development and industrialization of high-efficiency antibacterial agents will be concentrated in the Zhongshan Innovation Platform established by the University of Hong Kong-Guangdong Pharmaceutical University at the National Health Base.

In early 2018, Zhongshan City and the Macao government signed the "Framework Agreement on Jointly Establishing National Biomedical Science and Technology Innovation Zones", and fully cooperated to build the Innovation Zone into a world-class biomedical research and development cluster, an international biomedical industry base, and a world-class high-end medical care. Science and Technology Service Cluster and Guangdong, Hong Kong and Macao Biological Cooperation Innovation Demonstration Base.

According to Yuan Yongkang, deputy mayor of Zhongshan City, Zhongshan City has made active explorations and laid a good foundation in research and innovation, policy innovation, talent innovation and capital services in the process of pharmaceutical industry development.

In terms of pharmaceutical innovation and development, Zhongshan has built a public technology research and development platform, vigorously introduced high-level innovative research teams, introduced special policies for biomedical industry development and talent support, and cooperated with financial capital to help build a certain innovative strength. There are 46 new R&D projects. The organization, 42 post-doctoral work platforms, set up molecular diagnostics and genetic testing, biomedical materials, biomedical incubator industry base, and three national drug clinical experimental bases, a group of new drugs targeting tumor-targeted therapeutic monoclonal antibodies, 1. 1 new class of small molecule chemical drugs, high-end medical imaging equipment, genetic testing and molecular diagnostics, new technologies such as cellular immunotherapy.

In terms of policies, the “Zhongshan City Health and Pharmaceutical Industry Development Action Plan 2018-2022 Action Plan” was launched, focusing on supporting biomedicine, medical equipment, health food, and high-end specialty medical services, and fostering the integration and development of a new generation of information technology and health medicine industry. Up to 10 million yuan of grants or awards can be awarded for high-quality projects, capital expansion and technological transformation, use of bio-core equipment, and R&D platform construction. In addition, there are corresponding subsidies or incentives for the industrialization of new drug research, prevention of conformity assessment, international certification and industrialization.

In terms of financial capital services, Zhongshan provides diversified financial support through technology credit risk reserves, technology banks, guarantees, and financial leasing. The government actively guided and set up health and pharmaceutical industry investment, venture capital and angel investment funds. At present, seven investment funds focusing on health industries, including Besson Capital and Wu Jieping Health Industry Investment Fund, have been established to help technology-based enterprises start their businesses and become bigger and stronger.

In terms of talent integration, Zhongshan City has issued a “1+18” talent policy, which provides comprehensive talents for doctors and above, providing comprehensive talents such as housing, entrepreneurship, government subsidies, medical treatment, children's enrollment, and entry and exit.

In the future, Zhongshan will integrate the Guangdong, Hong Kong and Macao innovation resources under the favorable policies of Guangdong, Hong Kong and Macao Dawan District, learn from the Hong Kong and Macao mechanism, and carry out the innovation and development of the biomedical industry in advance, and explore the integration of medicine, medical and medical development in Guangdong, Hong Kong and Macao, and continue to contribute to China's health cause. .

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