In China, the application of FMSPs has been more than 30 years, and the gross output value of domestic FMSP market increased from RMB 120 million in 2004 to RMB 2 billion in 2015. National Health & Family Planning Commission of P.R.C. released GB 29922-2013 National Food Safety Standard: General Rules for FMSPs and other relevant normative standards. However, the current development of FMSP industry is still insufficient, especially the lack of systematic research on this industry. Through the utilization of the framework for industry innovation system, this paper analyzes the current situation of FMSP development promoted by local enterprises in China, and the development of local research institutions and policies, hoping to provide suggestions for FMSP development in China.
Summary of the proportion of Chinese-funded enterprises and foreign-funded enterprises
Foreign-funded enterprises:
A number of multinational companies, including Nutricia Pharmaceutical Co. Ltd., SSPC (Sino-Swed Pharmaceutical Corp. Ltd.), Abbott Laboratories, Nestle Corporation, have monopolized more than 90% in the domestic FMSP market. Most of the products of these companies are marked with "OTC", including a total of 69 domestically registered products, and 19 categories involved. The products introduced into China are mainly developed around 1980s. In addition, Abbott "full ansul" has been marked as a new standard FMSP and the pilot sale has started. Both Nutricia and SSPC have large-scale production bases established in Wuxi, Jiangsu of China, their products are available for use abroad, yet their R&D departments are not within China.

Table 1 Basic situation of foreign FSMP in China
 

Company name	Year of entry	Ownership system	Main products
SSPC (Sino-Swed Pharmaceutical Corp. Ltd.)	1982	Joint venture	Fresubin Energy Fibre, Fresubin, Supportan, Fresubin MCT 750, Fresubin Diabetes
Ajinomoto Pharma Co.,Ltd.	1984	Wholly foreign-owned	Elental
Novartis Pharma AG	1996	Joint venture	Impaet
Abbott Laboratories	1998	Wholly foreign-owned	Jevity, Ensure, Gluerna SR®, Pulmocare
Nutricia Pharmaceutical (Wuxi) Co. Ltd.	2000	Wholly foreign-owned	Nutrison Fibre, Peptisorb Liquid/ Powder, Diason®, Nutrison MCT, Nutrison, Neocate
Nestle Corporation	-	Wholly foreign-owned	Nutren,Vivonex

Note: Mark“-”means that the year of entry remains unclear
 
Domestic enterprises:
 Domestic enterprises mainly comprise Qingdao Haihui Biochemical Pharmaceutical Co., Ltd, Guangzhou Liheng Clinical Nutrition Co., Ltd. and other enterprises, accounting for about 10% of domestic market. Product approvals of these enterprises are marked with "Health care food product" and mainly used in nutriology departments of various hospitals. At present, due to the late entry time into industry, most of domestic enterprises mainly imitate foreign products, and they share such common characteristics as small market share, small proportion of independent intellectual property rights, lags in technology, small investment, and lack of brand influence. However, it is worth noting that some progresses of new product developments have been made in some local enterprises since the promulgation of new national standards. For example, Compound Nutrition Suspension and Enteral Nutritional Suspension newly developed by Shanghai DAISY FSMP have received the approval number approved by SFDA.
 
Table2 Basic situation of representative enterprises in China

Company	Year of establishment	Ownership system	Main products
Qingdao Haihui Biochemical Pharmaceutical Co., Ltd.	1958	Limited liability company (private)	Compound Nutrition Suspension
Xi' an LI BANG Clinical Nutrition Co., Ltd.	1999	Company limited	Leskon in-house products
Shanghai Richen Nutrition Products Technology Co., Ltd.	1999	Company limited	Richen compound nutrient supplement
Zhejiang Hailisheng Biotech	2000	Limited liability company (private)	Homogenized diets/Fish collagen poly phthalocyanine/ Deep-sea fish collagen powder/Dedicated for hospitals
Guangzhou EnterNutr Bio-Technology Co., Ltd.	2008	Company limited	Enternutr compound protein powder/ Enternutr homodiabet/Semi-Digested/ Enternutr Peptide/Enternutr Homogenate/ Enternutr whole/GLN/FIBER/OLIGO/
Guangzhou BOSSD	-	Enterprises directly under Sanjiu Group	Homogenate diets/ TRENSINE Composite Strengthening Nutrition Powder
Daisy FMSP Compound	2013	Company limited	Vegetable Protein Peptide Composite

Note: Mark“-”means that the year of entry remains unclear
 
Analysis of products and research institutions
FMSPs mainly comprise amino acid pattern, short peptide pattern and intact protein pattern. There are balanced type and disease specific type if classified by types, and there are diabetes type, tumor type, burn type, liver disease type and kidney disease type if classified by disease specific types. In the current domestic market, FMSP products from foreign-funded enterprises mainly comprise intact protein type enteral nutrition agents, i.e. Nutrison Fibre, Nutrison, Supportan, Fresubin Diabetes and Anso, short peptides and amino acids types, i.e. Elental, Peptison, and Peptisorb, and disease specific preparations, i.e. Fresubin Diabetes, Diason and TP HE mainly used for  people with diabetes. The product types of domestic enterprises basically follow that of foreign-funded enterprises.
Currently, FMSP-related researches and product developments have been conducted by scientific research institutions in Guangdong, Hubei, Zhejiang, Jiangsu, Shandong and Beijing, and some progresses have been made. At present, FMSP developments of China are mainly in its early stages. FMSPs mainly provide nutritional support for patients and closely related with clinical uses. However, FMSP-related clinical and basic research data in China are inadequate. More relevant researches are still needed as to whether newly-developed products can be more suitable for clinical applications and patients in China.
Domestic enterprises in China have also begun to try to cooperate with scientific research institutions for joint product developments. For example, Guangzhou Liheng Clinical Nutrition Co., Ltd versus Institute of Sericulture and Agricultural Products Processing, Guangdong Academy of Agricultural Sciences; Tianjin Zhongen Technology Co., Ltd versus Institute of Biophysics, Chinese Academy of Sciences.
 
Table 3 FMSP-related Research institutions

Location	unit (institutions)	Research contents
Beijing	CFSA (China National Center for Food Safety Risk Assessment) Institute of Nutrient Source	Researches on FMSPs standard and management
Beijing	Sun Yat-sen Hospital	Analysis and development of FMSPs Clinical effect
Guangdong Province	SYSU Wuhan Tallyho Biological Product Co., Ltd.	comparisons of specific FMSPs
Hubei Province	Hubei Peptide Material Engineering Technology Research Center	Prospect researches on the application of foodborne peptides in FMSPs
Zhejiang Province	Beingmate Baby & Child Food Co., Ltd. Zhejiang Key Laboratory of Chemical and Biological Processing of Agricultural Products	Domestic and foreign researches on standards for FMSP infant formula foods
Jiangsu Province	Wuxi Jiante Pharmaceutical Co., Ltd.	Using the flame atomic absorption spectrometry to research on the determination of interference and elimination of potassium and sodium in FMSPs
Shandong Province	Baolingbao Biology Co. Ltd. Research Institute of Agricultural Products,	Researches on the application of dietary fiber in FMSPs
Shandong Province	Shandong Academy of Agricultural Sciences	Current situation of FMSP industry

 

Policy environment is closely related to the development of medical food industry. Looking back the developments of FMSP-related policies in China, we can mainly divide them into the following three stages.
Stage I (1970—2000): Initial stage of policy. At this stage, along with the development of clinical nutrition, there are some knowledge about the clinical effect and social value of FMSPs. For example, there are reports on the clinical applications of FMSP in Beijing, China in 1974. In 1980-1990s, the unique position of nutrition and specialty in medical health system was clearly proposed.

Stage II (2002—2009): Stage of gradual attention: In 2002, Chinese Medical Association took the initiative to classify FMSPs, while government agencies began to gradually clarify their health insurance policies. In 2006, the importance of correct nutrition consumption on health was clearly proposed in the Action Plan for Chinese Nutrition Improvement. Moreover, guidance scheme for systemic parenteral & enteral nutrition was formulated in Clinical "Guidance" Series for Systemic Parenteral & Enteral Nutrition, which assisted physicians in considering the adoption of appropriate nutritional support program and corresponding operation specification for parenteral & enteral preparations according to the patients' clinical conditions.
During this period, China reflected certain requirements for technologies and functions of FMSP, and also pointed out problems brought about by unmatched policy packages, which provided the scientific basis for the adjustment and perfection of FMSP-related policies.
Stage III (2009—2015): Stage of policy refinement. The "food" identity of FMSPs was specified in the new Food Safety Law. Before that, FMSPs were managed according to the chemical drug registration management prescribed in the State Pharmaceutical Administration Law, which affected the product development of FMSPs in China and also restricted the entry of products from foreign-funded enterprises.
In order to solve the problems arising from product developments and clinical demands, National Health & Family Planning Commission of P.R.C. put forward the "2 + 1" standard management program. State Food & Drug Administration also released the Regulatory Measures for the Registration of FMSPs (trial implementation), so as to provide institutional guarantee and technical support for control and surveillance over FMSPs, enable the established regulations to be in conformity with the law, the realistic demands of regulatory authorities and manufacturers, fundamental needs for the quality safety of FMSPs, and clarify registration conditions, enterprise production capacity, clinical trials, etc.
Through the retrospective analysis of the development of Chinese medicine formula food industry, it can be found that there are 3 challenges in the development of Chinese medicine formula food.


First of all, limited scientific research support and lack of evidence-based medicine have restricted the industry development to some extents.


For example, foreign brand products sold in the market are compounded by use of single nutrients, resulting in high osmotic pressure, incompetence for gastrointestinal tolerance among Chinese people and easy occurrence of diarrhea among patients. On the other hand, domestic brand products are featured with low pre-digestibility, scattered brewing and poor nasal-feeding liquidity. These technical problems have become obstacles for FMSP developments in China. Furthermore, as FMSP does not provide single physiological function with clear direction, it is also difficult to evaluate during the clinical trial stage. Therefore, clinic should be coordinated with scientific developments.
 
Secondly, foreign companies dominate the market, and local enterprises are facing barriers to entry. At present, foreign brands have occupied a dominant position in the market, while domestic brands account for only about 10% of the market. More local enterprises want to enter the FMSP industry, but they have to face with all kinds of difficulties. As a result, the majority of enterprises hold the attitude of wait-and-see. In particular, new entrants need to re-establish a production line in conformity with relevant provisions of food production, and also need for more investments in test and inspection, which means a huge challenge for domestic enterprises.
 
Thirdly，at present, the relevant national policies, regulations and standards are still imperfect, and such links as product approval and regulation of production and market are not standardized. Although the newly-released standards allow consumers to make a major shift in the understanding of FMSPs, and also define the distinction between functional foods and health care products, yet sports food, health food or functional food are still included under the FMSP directory of some enterprises, which shows that many efforts in policy implementation are still required during the fulfillment and enforcement of new standards. 
 
In addition, the health-seeking behaviors among people and the mindset in doctors’ treatment also affect the application of FMSPs. On one hand, it is still difficult for doctors to accept products under the name of "food". On the other hand, the treatment conception among patients also tends to be dominated by doctors. i.e. too much emphasis on drug treatment, with negligence of the role of FMSPs in treatment and rehabilitation. Moreover, FMSPs can’t be supplemented into the medicare system, and consumers can’t be reimbursed, which is also an influencing factor.
 
It is precisely because of the above problems that FMSP developments in China still lag behind the developed countries in Europe and the U.S.A. In view of the huge population and the increasing demands for nutrition and health, FMSPs are sure to have a very good prospect in the future. FMSPs are still in its initial stage of industrial development in China, and it is required to start from the perspective of industrial innovation system and make collaborative efforts in terms of three aspects, i.e. knowledge & technology development, enterprise & network construction, and policy construction. Only in this way, positive and further development can be obtained in Chinese FMSP industry.