Blood products (phase I) project
Feasibility study report
Securities abbreviation: Boya Bio-Pharmaceutical Group Co.Ltd(300294) securities code: Boya Bio-Pharmaceutical Group Co.Ltd(300294)
March, 2002
catalogue
Chapter I Project Overview 3 I. project name 3 II. Source of project construction funds 3. Project implementation subject and location 3 IV. planning objectives 3 Chapter II project construction background and necessity 4 I. blood products industry and policy background 4 II. Strategic development needs of the company 5 III. in line with the development orientation of national and local biomedical industry 6 IV. requirements for ensuring people's life and health 7 v. the project is feasible and necessary 8 Chapter III project construction scheme 8 I. project construction scheme 8 II. Engineering design scheme 11 III. product scheme and production scale 12 IV. project equipment scheme Chapter IV construction investment estimation 20 I. project construction investment funds 20 II. Initial working capital 20 III. total investment of the project submitted for approval 20 IV. total investment in financial evaluation 20 v. fund raising 20 Chapter V project construction period 20 I. project construction period twenty
2、 Change period of production place of listed varieties 21 III. change of production site during clinical trial of R & D products Chapter VI Financial and economic evaluation 22 I. fund use plan 22 II. Estimation of business income, business tax, surtax and value-added tax 22 III. cost estimation and description 23 IV. analysis of project profitability 23 v. breakeven analysis 23 VI. financial evaluation conclusion Chapter VII risk analysis and Countermeasures 25 I. policy risks 25 II. Risk of raw material supply and raw material price change 25 III. risk of R & D products 25 IV. organizational guarantee risk 25 v. project implementation risk 26 VI. technical risks of the project 26 Chapter VIII feasibility study conclusion twenty-six
Chapter I Project Overview
1、 Project name
Project Name: blood products intelligent factory (phase I) construction project
2、 Source of project construction funds
The total investment of the project is 309684 million yuan, including 204705 million yuan of project construction investment and 104979 million yuan of initial working capital. The source of funds is 9960751 million yuan raised by the company in 2018 and self raised funds.
The construction investment of the project is 204705 million yuan, as shown in the table below:
Proportion of estimated investment in investment
Serial number item name
(10000 yuan) (%)
1. Project cost 16966182.88
2. Other expenses of project construction 2434011.89
3. Reserve fund 7760 3.79
4. 2945 1.44 has been invested in the early stage
5 total 204705100
3、 Project implementation subject and location
Subject of project implementation: Boya Bio-Pharmaceutical Group Co.Ltd(300294)
Location of project implementation: Fuzhou high tech development zone extends to Keji Avenue in the East, Chengxin Avenue in the south, Zhenxing Avenue in the West and dream chasing road in the north.
Project construction land: the total area of the project land: 658.13 mu. Including: production base (East plot): 335.39 mu, group functions and Shenzhen New Industries Biomedical Engineering Co.Ltd(300832) reservation (West plot): 322.74 mu.
As of now, there are still uncertainties about whether the project can pass the EIA (bidding, auction) and subsequent procedures, and whether the project can pass the EIA (bidding, auction) and the final filing time. The company will fulfill the obligation of information disclosure in time according to the progress of the matter. Please pay attention to the investment risk.
4、 Planning objectives
In order to meet the needs of the rapid growth of the company's plasma collection in the future, through the application and improvement of the existing technology, the project will build an intelligent factory with an annual input of 1800 tons of plasma blood products, optimize and upgrade the scale and products, strengthen the company's production capacity, improve the comprehensive utilization rate of plasma, and provide more customers with high-standard blood products. At the same time, through the construction of intelligent factory, realize the intellectualization of production mode, logistics storage, production equipment and product service system, further improve production efficiency and product quality, reduce operation cost and meet the needs of sustainable development of enterprises.
Chapter II project construction background and necessity
1、 Blood products industry and policy background
Blood products are derived from plasma and are widely used. They are rigid and difficult to replace. Blood products are bioactive preparations prepared from healthy human plasma by biological technology or separation and purification technology. According to proteomic determination, plasma contains more than 10000 kinds of plasma proteins, of which more than 200 are known to humans, more than 20 are used for clinical treatment abroad, and about 14 kinds of blood products can be produced under China's existing technology, including human albumin, immunoglobulin, coagulation factor and other protein components.
Blood products have a wide range of indications, have the attribute of rigid demand, and the industry demand is relatively certain and difficult to replace. At present, the only varieties that can be produced through genetic engineering are recombinant human coagulation factors and recombinant anti rabies virus monoclonal antibody. Due to factors such as cost and safety, only recombinant human serum albumin has been approved for the production of pharmaceutical excipients in the global market, and there is no pharmaceutical grade recombinant human serum albumin on the market (among which, the pharmaceutical grade recombinant human serum albumin (trade name Medway) of Japan tanbian Mitsubishi Pharmaceutical Co., Ltd. was listed in 2007, However, due to tampering with laboratory data (withdrawn from the market in 2009), it is difficult to obtain approval for the industrial production of pharmaceutical grade recombinant human albumin, and it is still difficult to replace the human albumin extracted from plasma.
Chinese blood and plasma donors are strictly separated, and plasma has resource attributes. Due to strict supervision and superimposed access barriers, the supply elasticity is small, and the slurry mining gap exists for a long time. China's blood products industry has strict collection standards and regulatory policies, making it difficult to enter. Since 1985, China has banned the import of other varieties except human albumin, which has a large gap between supply and demand. Since 1998, the blood products industry has implemented GMP access system. Since 2001, the state has no longer approved new blood products production enterprises, and the threat of new entrants in the industry has been basically eliminated. Since November 2007, the state has allowed the import of recombinant human coagulation factor VIII (but coagulation factor VIII from human plasma is still not allowed to be imported).
Compared with the United States and Europe, China's plasma collection policy is more stringent, the plasma collection interval is longer, and the single collection volume is also less. In terms of quantity and growth rate, the number of plasma stations and plasma collection volume of the industry in China are lower than those in the United States. With the strict approval of new pulp stations, the growth rate of the number of pulp stations and pulp production in China has further slowed down in recent years. According to the announcement statistics of various companies, the number of plasma collection stations in China was about 245 in 2018 and 252 in 2019, with a year-on-year increase of only 2.86%. The compound growth rate from 2010 to 2018 was about 5.80%, which was less than the compound growth rate of 7.79% of the number of plasma stations in the United States in the same period; In 2018, the plasma collection volume of China's blood products industry was about 8622 tons, and in 2019, about 9200 tons, with a year-on-year increase of 6.70%. The compound growth rate from 2010 to 2018 was about 9.47%, which was less than the compound growth rate of 11.17% of the plasma collection volume in the United States in the same period.
The consumption of different blood products varies from 2 to 25 times, and the industry has great potential to improve. Influenced by the policy of banning the import of blood products (except human albumin) for more than 30 years (including payment factors, product marketing and other factors), there are great differences between China's blood products market structure and the global blood products market structure. From the perspective of per capita dosage, there is 2-10 times more room for improvement of Chinese blood albumin and intravenous propyl compared with foreign countries. Blood clotting products will be mainly driven by the expansion of blood clotting products and blood products per capita in the Chinese market in the long term, but with the continuous expansion of blood clotting products in the short term, blood clotting products will be mainly driven by the expansion of blood clotting products in the Chinese market.
2、 Strategic development needs of the company
The establishment and approval of the new pulp station is strict, the policy is good for the leading enterprises, the policy is good for the superposition of regional scale advantages, and the leading enterprises' pulp station resources are always strong. According to statistics, from 2017 to the end of 2020, the number of Beijing Tiantan Biological Products Corporation Limited(600161) newly approved pulp stations is far ahead of the industry, reaching 10 pulp stations, while the industry average is about 2-3; From the proportion of newly approved pulp stations in the total number of pulp stations of the company, the proportion of Boya Bio-Pharmaceutical Group Co.Ltd(300294) new pulp stations is the highest, followed by Beijing Tiantan Biological Products Corporation Limited(600161) and Taibang biological. Considering that it takes about 1-2 years from the approved setting of pulp stations to obtaining the pulp mining license, and it takes 3-5 years from the formal mining of pulp stations to the basically stable pulp mining volume, enterprises with a large number of newly approved pulp stations and a high proportion are expected to obtain greater performance flexibility in the future. Considering the special requirements of the blood products industry for safety, the future regulatory requirements are unlikely to be relaxed, and the country is unlikely to liberalize imports. Therefore, the attribute of scarce resources of blood products will continue to appear.
In December 2021, the company obtained the reply from Shanxi Provincial Health Commission, agreeing to set up Yangcheng Boya plasma collection station (under construction) in Yangcheng County, and the number of plasma stations of the company increased to 14. Strive to achieve more than 30 pulp stations and more than 1000 tons of pulp mining scale during the 14th Five Year Plan period.
Only the expansion of pulp stations in the 14th five year plan is considered, and the new expansion of pulp stations in the 15th five year plan is not considered temporarily. It is calculated according to the annual growth rate of 8% of pulp collection. From 2024 to 2026, it is calculated according to full production, including 45 tons of production transfer validation batch plasma in 2026. Considering the continuous growth of performance and the arrangement of qualified plasma, it is calculated as 1200 tons in 2027 and 1800 tons in full production after 2028. At the end of 2023, the plasma inventory is expected to reach 395 tons, and the existing plant plasma bank can only hold 200 tons of plasma. Therefore, it is planned to build the plasma bank first in 2023, and expand or build a new plasma bank in the existing plant.
Boya Bio-Pharmaceutical Group Co.Ltd(300294) the existing blood products production workshop was built in 2009, and the designed production scale is 500 tons of plasma per year. The factor product production and R & D building (the workshop has three floors and one floor is reserved) was put into use in October 2017. It is mainly used for the production of human fibrinogen and human coagulation factor VIII. It can meet the production of 6 tons of plasma / batch, human fibrinogen fed once every three days, 6-12 tons of plasma / batch and human coagulation factor VIII fed once every three days. The maximum production capacity is 600 tons of plasma, which is difficult to match the increase of plasma volume. The existing blood preparation workshop is old, most of the process equipment and power equipment were installed in 2009 (the key sub assembly line was purchased in 2001), the performance of the equipment is reduced, and the risk of production deviation is high; At the same time, the storage capacity of plasma and materials is seriously insufficient, which is difficult to meet the increase of production capacity and varieties. After 2023, the supply of raw plasma will be greater than the existing capacity, so it is urgent to build a new plant.
With the increase of plasma stations, the increase of plasma collection volume and the continuous improvement of R & D capacity, the comprehensive utilization rate of plasma has been improved. The existing production workshops are difficult to meet the production needs of human albumin, intravenous human immunoglobulin and other new products. Therefore, a production workshop with an annual feeding capacity of 1800 tons of plasma and blood products must be built and put into use in 2027 to meet the needs of Boya Bio-Pharmaceutical Group Co.Ltd(300294) development.
After years of social development, a large number of residential areas and other civil facilities have been built around the current plant area of Boya company, which has a certain contradiction with the company's production in terms of environmental protection and safety. If the expansion in the existing plant area is adopted, the contradiction between environmental protection and safety will be greatly enlarged, which is very unfavorable to the long-term development of the company in the future. Therefore, in order for the company to break through the existing bottleneck, expand production scale, expand product types and realize leap forward development in the future, the project needs to find new plots and build a new large-scale production base. 3、 In line with the development orientation of national and local biomedical industry
The 14th five year plan for the development of pharmaceutical industry has incorporated "implementing the strategy of manufacturing power" into the guiding ideology, taken "systematic improvement of manufacturing level" as the development goal and "promoting the systematic upgrading of pharmaceutical manufacturing capacity" as the main task, highlighting the importance of improving manufacturing level and creating manufacturing advantages.
High quality development plan of pharmaceutical industry in the 14th five year plan of Jiangxi Province
