Analysis of advantages and disadvantages of Chinese pharmaceutical cro industry

Analysis of the disadvantages of cro industry in China there are many problems in China's pharmaceutical cro industry, some of which are related to the development stage, some of which are related to the overall technological innovation ability of China's chemical medicine industry and biotechnology industry （1） Compared with the Western cro industry, China's cro industry is still in the primary stage of development It is mainly reflected as follows: 1 Although there are many pharmaceutical cros in China, most of them are small and medium-sized enterprises and lack of leading large enterprises At present, there are thousands of cros in China, especially the rapid expansion of the number of clinical cros Many of these cros are mainly registered and declared with low service level, the quality of service is uneven, and they can not provide complete clinical trial services For example, in October 2009, the international cro giant PPD acquired excel Pharma studies Inc., a clinical cro Two months later, PPD purchased Baonuo technology, one of the largest cros in northern China, for another US $77 million In 2011, icon acquired the largest clinical cro in China In addition, the sales revenue and total assets of major cros in the West are significantly higher than those of major cros in China Therefore, how to support China's major cros to become international cro giants is an urgent task 2 China's pharmaceutical cro industry structure is unreasonable Cro is either concentrated in the field of new drug discovery and preclinical research, or in the field of clinical research The service content is relatively simple, and there is a lack of cro that can provide the whole process of new drug research and development In China, cro can be divided into two categories: the first category is the local preclinical cro mainly engaged in the discovery of new drugs and preclinical research, especially in the research and development of chemical synthesis, biochemistry, etc., which is at the high end of the value chain and undertakes the R & D outsourcing of large foreign pharmaceutical enterprises and biotechnology enterprises, with Wuxi yaomingkant and Shanghua pharmaceutical as typical representatives These preclinical cros are limited to part of the process of new drug development The second type is the local clinical cro mainly engaged in clinical trials and new drug registration, which is at the low end of the value chain, with tiger medicine as a typical representative 3 China's pharmaceutical cro lacks qualification Although some pharmaceutical enterprises in China have taken cro as an available external resource, there are still quite a number of pharmaceutical enterprises that are not familiar with cro The main reason lies in the lack of qualification identification of cro in China at present, as long as they have the ability to provide technical services in accordance with the contract and are regular legal organizations There is no access threshold, which leads to a mixture of good and bad in China's cro industry, which greatly hinders the use of cro by Chinese pharmaceutical enterprises Some pharmaceutical companies are only willing to cooperate with regular and powerful cros 4 The construction of drug clinical trial institutions in China needs to be strengthened Cro is only the intermediary organization of clinical trials The clinical base used in clinical trials belongs to drug clinical research institutions Cro is mainly entrusted by the sponsor to sign clinical trial agreements with drug clinical trial institutions and researchers In 2004, China issued the measures for the qualification of drug clinical trial institutions (Trial) By the end of 2011, China had approved 436 drug clinical trial institutions In China, GCP training is required for qualification certification of drug clinical trial institutions, but there are not many high-level drug clinical trial institutions in China, which makes the authenticity of data collection and management not improved 5 The overall level of clinical cro in China is not high From the level of clinical cro, at present, the technical service level of China's clinical cro is quite different, and the overall level is not high, mainly divided into three levels: first, a few clinical cros can meet the requirements of ICH-GCP and China's GCP quality specifications at the same time, and can provide all kinds of clinical trial services for domestic and foreign pharmaceutical enterprises, typical representative is a few local enterprises such as tiger pharmaceutical Second, the technical service level of some clinical cros can meet the requirements of China's GCP, but can not meet the more stringent ICH-GCP Its main business is to provide phase II to IV clinical trial services for domestic pharmaceutical enterprises' generic drug applications Third, most clinical cros can only provide simple services such as registration application and data translation 6 From the perspective of clinical trial service category, most of them are clinical trials of generic drugs At present, the clinical trials in China mainly include registration test, import validation, international multicenter test (MCT) and post marketing test At present, the clinical trials carried out by domestic pharmaceutical enterprises account for a large proportion of the overall clinical trials in China, among which the clinical trials of generic drugs account for the majority, and the capability and requirements of clinical studies of generic drugs for cro are far lower than those of MCT and innovative drugs for cro 7 China lags behind India and other neighboring countries in undertaking the international multicenter test (MCT) MCT is a clinical trial organized by the sponsor and conducted by several researchers in different countries and different sites according to the same trial plan The main candidates of MCT are foreign large pharmaceutical enterprises and biotechnology enterprises Although MCT only accounts for a small proportion of clinical trials carried out every year in China, it represents the highest level of drug clinical research In recent years, foreign pharmaceutical and biotechnology companies hope to transfer early R & D to China, India and other developing countries on a large scale But at present, China's regulatory laws and regulations are not in line with the international standards, and the approval time is too long, so that many MCT can not be put into China 8 The construction of cro's central laboratory is still in its infancy The concept of central laboratory originated in the United States in the 1980s When the logistics industry can provide professional services for the transportation of biological samples, the central laboratory began to be promoted in the world As an important segment of cro business, the central laboratory has just started in China, mainly because the global cro giants have established a central laboratory in China One of the important reasons is that China's control over the import and export of biological samples is more strict than other countries and regions The central laboratory must pass international standards such as cap However, unless it is an international multi center experiment, at present, the domestic cro's demand for the central laboratory is quite limited 9 Site management organization (SMO) is still in its infancy in China In the west, SMO plays an intermediary role between pharmaceutical companies or cros and researchers: on the one hand, SMO provides qualified researchers for pharmaceutical companies or cros; on the other hand, SMO wins clinical research projects for researchers Cro relies on CRA (Clinical Research Associate, also known as monitor) to take charge of clinical supervision The SMO directly assists the implementation of clinical research and provides the service of study coordinator, who directly assists researchers In China, cro can be in line with international standards, because the quality of CRA is similar to that of foreign countries The research coordinator service provided by SMO is one of the most needed services in the field of clinical research in China In the west, the vast majority of clinical research is done by the research coordinator, while the vast majority of drug clinical trial institutions in China do not have a professional research coordinator 10 There is still a gap between the legal and regulatory environment of preclinical research and clinical research in China and that in the West Primates are used in preclinical research, but there is still a lack of complete experimental animals and animal experiment laws and regulations in China to ensure the research quality and biosafety China's current regulations on animal experiment management mainly refer to the standards of the United States and Europe In 2003, GLP was issued and implemented, and in 2007, the management measures for certification of GLP were issued In clinical research, ICH-GCP is the international general standard and the highest standard in the industry GCP is a clinical trial standard issued in China, which is not detailed enough and plays a guiding role In most cases, the requirements of ICH-GCP are more stringent than those of GCP 11 Domestic pharmaceutical enterprises attach great importance to cooperation with universities and research institutes, and do not attach importance to cooperation with pre clinical cros At present, cro in China is still blooming outside the wall and fragrant outside the wall before clinical practice, with few domestic customers One of the main reasons is that domestic pharmaceutical enterprises rely on the cooperation between universities and scientific research institutes 12 China's cro has more domestic intellectual property application activities, less international intellectual property application activities, and the R & D outsourcing mode limits the technology accumulation of China's cro Taking Wuxi Wuxi Wuxi Wuxi Wuxi Pharmaceutical Co., Ltd as an example, the patent application of the company is mainly at home, and there are few foreign patents, the main reason is that the company is subject to the business model of cro （2） Cro in China has many limitations in promoting the technological innovation of chemical medicine and biotechnology industry It is mainly reflected as follows: first, like the Western cro, China's cro, as a service organization, only plays a limited and auxiliary role in the technological innovation of chemical medicine and biotechnology industries Chemical medicine industry is famous for its high R & D investment International pharmaceutical enterprises often spare no effort in the R & D investment of chemical medicine Therefore, the technological innovation of chemical medicine and biotechnology industry is mainly reflected in the pharmaceutical design and drug discovery of pharmaceutical enterprises and biotechnology enterprises, which are in the upstream link of the value chain, rather than in the preclinical research And clinical research are in the middle and lower links of the value chain The main gap between China's chemical and biotech enterprises and foreign pharmaceutical and biotech enterprises lies in drug design and drug discovery The technological innovation and industrial upgrading of China's chemical and biotech industries mainly depend on the pharmaceutical enterprises and biotech enterprises themselves to improve the technological innovation ability of drug design and drug discovery, rather than relying on cro for China's pharmaceutical enterprises and biotech enterprises Biotech companies provide R & D outsourcing services for drug design and drug discovery Second, different from the Western cro, China's cro is now more of an intermediary service The proportion of new drug research and development and new drug design with high technological innovation and pre clinical research with high technological content is not high Cro in China is mainly engaged in three major businesses: new drug research and development, preclinical research and clinical research Among them, the content of new drug R & D technology innovation is high, the content of pre clinical research technology innovation is high, and the content of clinical research technology is not high, mainly reflected in intermediary services, attracting a large number of cros At the same time, the domestic chemical industry is dominated by generic drugs, which makes the demand of domestic pharmaceutical enterprises for cro limited to clinical trials New drug R & D outsourcing of pre clinical cro in China is mainly for the international market, and the domestic demand is still in the initial stage Third, there is a conflict of interest in upgrading cro to pharmaceutical enterprises, which makes it difficult for cro to get rid of the role of OEM Taking Wuxi pharmaceutical as an example, Wuxi pharmaceutical has two ways to expand its cro service in the future One is to expand its cro service content and become an all-around cro For example, Wuxi pharmaceutical acquired two clinical trial management service companies in 2011, which are Jinshi pharmaceutical and Jiecheng pharmaceutical respectively The two companies are related to each other and their business is mainly to provide clinical trial management services The other way is to expand the business from R & D outsourcing to manufacturing outsourcing, and play both cro and CMO roles, becoming cro + CMO CMO refers to contract processing outsourcing Although the development of cro industry in China is still in the primary stage, cro has a bright future in China This is because China has its own advantages in developing cro industry, mainly including the following six aspects: 1