7. Favorable and unfavorable factors affecting the industry

8. Favorable factors

(1) The policy support of the state to the pharmaceutical industry is an important foundation to support the sustainable development of the medical and health services industry. It is a sunrise industry with strong growth, relevance and driving, and plays an active role in benefiting the people's livelihood and stabilizing growth. In order to enhance the core competitiveness of China's pharmaceutical industry and promote the sustainable and healthy development of the industry, the State Council, the State Food and Drug Administration and other departments have continuously launched new policies to support the development of the pharmaceutical industry.

On March 11, 2016, the State Council issued the national strategic plan for the healthy development of the pharmaceutical industry, issued the guidance on promoting the healthy development of the pharmaceutical industry, and made guiding arrangements for the strategic position, current situation and future development plan of the pharmaceutical industry in the development of the national economy. In the future tasks, it was pointed out that "accelerating the research and development of new biological drugs such as antibodies, proteins and polypeptides" And industrialization ", pointed out the direction for the development of peptide industry.

(2) Medical and health system reform will further promote the development of the pharmaceutical industry

In order to solve the problem of "difficult and expensive medical treatment" and provide safe, effective, convenient and cheap medical and health services for the masses, the government proposes to establish and improve the basic medical and health system covering urban and rural residents. The long-term goal of deepening the reform of medical and health system is to basically establish a basic medical and health system covering urban and rural areas by 2020.

Deepening the reform of the medical and health system in China will promote the construction of the basic medical security system and establish and improve the government's health investment mechanism. The burden of the residents' personal basic medical and health expenses will be effectively reduced, which will promote the residents' medical and health consumption and make more drugsThe market scale will be greatly increased, which will bring long-term benefits to China's pharmaceutical manufacturing industry.

(3) Increasing market acceptance of peptide drugs

At present, peptide drugs are mainly administered by small volume injection, with small dosage and easy clinical application. At the same time, because the polypeptide is an endogenous component of human body, its half-life in vivo is short, which has the characteristics of good efficacy and small side effects. In recent years, with the continuous development of peptide medicine industry and the continuous expansion of clinical application, doctors' acceptance of peptide medicine is increasing, which further drives the development of peptide medicine.

At present, peptide drugs have been widely used in endocrine system, immune system, digestive system, circulatory system, musculoskeletal system and other treatment fields. As the main peptide drugs, thymopentin and thymus method have two-way immune regulation effect. In the future, the market dosage will be further improved, and patients' acceptance of peptide drugs will be increasingly improved.

(4) The aging population will stimulate the demand of peptide drugs market

China's aging population is speeding up, and the elderly are high consumers of medical services, which will enhance the demand of consumers for medicine. The country's investment in medical and health services is also growing, and the consumption of medicine is increasing. According to the survey of the former Ministry of health, the incidence of the elderly is 3-4 times higher than that of the young and the hospitalized rate is 2 times higher. In recent years, the incidence of cancer in China has increased by 3% every year, which is higher than that in rural areas,The main factor is aging. According to statistics, most of the 62 kinds of malignant tumors in the world have a high incidence after 60-70 years old. Therefore, with the acceleration of aging in China, the demand for chronic diseases, especially anticancer drugs, will further increase.

The growth trend of the aged over 65 in China

Source: public data sorting

(5) Peptide drug patent expires, domestic generic pharmaceutical enterprises welcome development

At present, most polypeptide drugs produced by domestic enterprises are generic drugs. 2016-2019 is the peak period of patent expiration for the heavyweight drugs in the global polypeptide drugs. With the expiration of patents for such varieties as gratiret, exenatide and lilalutide, the same varieties of domestic generic drug enterprises will continue to be approved for listing, undoubtedly bringing opportunities to many domestic generic drug manufacturers.

Patent expiration of major peptide drugs in the world

Indications for expiration of patent of original research enterprise

Exenatide Byetta AstraZeneca December 2016 type 2 diabetes

Copaxone Tila in January 2017 multiple sclerosis

Lilalutide Victoza Novo Nordisk August 2017 type 2 diabetes

Tetrapeptide Forteo Lilly osteoporosis December 2018

Gserelin Zoladex, AstraZeneca, prostate cancer, etc., April 2022

Source: public data sorting

2. Adverse factors

(1) Slow progress in research and development of innovative drugs in China

The pharmaceutical industry has the characteristics of "high investment, high risk, long cycle and high income". The R & D, registration and certification of products need huge and continuous capital investment. For the development of new products, from the research and development to the approval of production and listing of new products, it needs to pass small-scale test, pilot test, clinical, scale-up and verification, commercial production and other links,The product can only be put into production after obtaining the drug approval number and passing the GMP certification. The whole process needs a lot of experimental research, with long cycle, high cost and the possibility of development failure. Even after the successful development, there are some uncertainties to obtain the drug approval number and pass the GMP certification.

Due to the above characteristics of the pharmaceutical industry, under the background that the R & D strength and investment of China's pharmaceutical industry are still relatively insufficient, the R & D process of China's innovative pharmaceutical industry is relatively slow, which to some extent restricts the development of China's peptide pharmaceutical industry. These factors lead to the slow development of peptide innovative drugs in China.

(2) Intensified market competition

Peptide medicine industry belongs to high-tech barrier industry, and the competition of high-end new products is relatively relaxed. However, with the increasing attention to peptide medicine in the investment field, the competition will be increasingly intensified. In addition, more and more domestic pharmaceutical enterprises have a deeper understanding of the product advantages and market prospects of peptide drugs. With the expiration of some peptide drug patents, the research and production level of domestic generic drugs has entered a new stage, and the market competition has intensified.

In addition, with the improvement of people's living standard and drug use level in China, foreign large pharmaceutical groups continue to increase their development and investment in the Chinese market, the time for their products to enter the Chinese market may be gradually shortened, and their international brand advantages, advanced management mode and high-level scientific research investment will further intensify the degree of competition in the domestic market.
(3) Insufficient R & D investment and weak ability of sustainable development

The R & D expenses of pharmaceutical enterprises in developed countries generally account for about 15% of sales revenue, while the R & D expenses of pharmaceutical enterprises in China account for about 2% of sales revenue on average. Lack of R & D investment limits the development and innovation of pharmaceutical enterprises in China. At present, more than 95% of chemical pharmaceutical preparations in the domestic market are brand drugs with expired patents, which will have a negative impact on the sustainable development of the pharmaceutical industry in China.

At present, peptide pharmaceutical enterprises are generally small in scale and lack of R & D investment, most of which are at a low level. Due to the lack of R & D funds, most of the enterprises in China can not become the main body of pharmaceutical R & D, resulting in some key industrialization technology has not been broken through for a long time, which restricts the update of products and cannot meet the market demand in time.

(4) Relatively single route of administration

Due to the chemical properties of polypeptide drugs, the main types of preparations are freeze-dried powder injection and small volume injection, which are mainly intravenous injection or drip injection, and the route of administration is relatively single. At present, the proportion of polypeptide drug injection is more than 75%. The single route of drug administration has hindered the development of chemical synthesis of polypeptide drugs to a certain extent.

In recent years, great progress has been made in the research of peptide drug delivery routes. New types of preparations have been developed by the application of new technologies, including microspheres long-term slow-release agents, inhalants, etc., which effectively prolong the half-life of peptide drugs in vivo, significantly improve the bioavailability, and provide doctors with alternative treatment means in the treatment of various difficult diseases Generic drug delivery technology has become a research and development hotspot of many pharmaceutical enterprises.

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Chengdu Shengnuo Biotechnology Co., Ltd. has "Chengdu polypeptide drug engineering technology research center" in Chengdu, mainly engaged in polypeptide, polypeptide drug and beauty peptide research. Our zero defect has passed the FDA certification, and now it has become the first-class professional peptide drug and product development, technology transfer, technical service and peptide drug industry in the scale production and export of China's parks.