Stock code: 300122 Stock abbreviation: Zhifei Biological Announcement Number: 2016-22
Announcement of Chongqing Zhifei Biological Products Co., Ltd. on the use of its own funds to invest in the construction of a polysaccharide production workshop
The Company and all members of the Board of Directors warrant that the contents of the announcement are true, accurate and complete, and accept responsibility for false statements, misleading statements or material omissions in the announcement.
1. Project Overview
According to the company's development strategy, in order to enrich the product structure, expand the industrial scale, develop innovative technologies and innovative products, and enhance the competitiveness of enterprises, the company intends to use its own funds to invest in the construction of the third phase of the pilot building polysaccharide production line project, which has been deliberated and approved by the sixth meeting of the third board of directors of the company, and agreed to submit the project to the public
The Company began construction after the approval of the 2015 Annual General Meeting of Shareholders, as follows:
1. Project Name: Beijing Zhifei Luzhu Biopharmaceutical Co., Ltd. Phase III Pilot Building Polysaccharide Production Line Project (hereinafter referred to as "Zhifei Luzhu Polysaccharide Production Workshop Project");
2. Implementing entity: Beijing Zhifei Luzhu Biopharmaceutical Co., Ltd. (hereinafter referred to as "Zhifei Luzhu");
3. Implementation location: Zhifei Green Bamboo Vaccine New Variety Industrialization Production Base Project (Beijing Economic and Technological Development Zone X53F2 Plot).
4. Investment plan project name total investment (10,000 yuan)
Source of funds (10,000 yuan) Project period
(Year) The main body of the project implements the self-financing Zhifei Green Bamboo Polysaccharide Production Workshop Project
31809.59 31809.59 4 Zhifei Green Bamboo
5. Investment methods
The total investment of this project is 318.0959 million yuan, and the company will invest in the Zhifei Green Bamboo project according to the actual progress of the project, of which:
Construction costs 61.8492 million yuan accounted for 19.44% of construction investment
Equipment purchase cost 197.7308 million yuan accounted for 62.16% of the construction investment
Equipment installation cost 2.7018 million yuan accounted for 0.85% of construction investment
Other project expenses 16.7404 million yuan, accounting for 5.26% of construction investment
Reserve fee 39.0637 million yuan accounted for 12.28% of construction investment
6. Project construction scale and use: The construction area of the project: 7960 m2; the vaccine production vehicle has been completed
Implemented within one to four layers, including: pneumonia polysaccharide production line, meningitis polysaccharide production line and dysentery polysaccharide production line.
Second, related product introduction
Zhifei green bamboo polysaccharide production workshop is mainly used for A, C, Y, W135 polysaccharides, Hib polysaccharides, 23 types of pneumococcal polysaccharides, 2 types of dysentery cocci vaccine preparation required polysaccharide production, the product conditions involved are as follows:
1. A, C, Y, W135 group meningococcal polysaccharide vaccine is made by using A, C, Y, W135 group meningitis Neisseria culture solution, extracted from the capsule polysaccharide antigen, purified and then added with a suitable stabilizer to freeze dry. Vaccination is given to children >2 years of age and adults for the prevention of meningococcal meningococcal influenzae in groups A, C, Y, and W135.
2. The combined vaccine of meningococcus acylosa (conjugate) Haemophilus influenzae type b (conjugate) is purified group A,
Group C meningococcal polysaccharides and Haemophilus influenzae type b polysaccharides are covalently bound and purified with tetanus toxoids, respectively, and adsorbed with aluminum hydroxide adjuvant. Infants and children aged 2 months to 71 months are used to prevent infectious diseases caused by group A, group C meningococcal bacteria and Haemophilus influenzae type b, such as meningitis, pneumonia, sepsis, epiglottitis, etc.
3. Group A meningococcal polysaccharide vaccine is used for group A and group C meningococcal culture solutions, which are respectively mentioned
Take and purify the group A and C meningococcal capsular polysaccharide antigens, mix and add lactose to freeze-dry to make. Vaccination is given to children >2 years of age and adults for the prevention of meningococcal meningoccal influenzae in groups A and C.
4. A group C meningococcal polysaccharide conjugate vaccine is made by using Neisseria a culture solution of Neisseria meningitidis in group A and group C, purifying and obtaining pod polysaccharide antigens, combining it with tetanus toxoids, and then being purified and adsorbed with aluminum hydroxide adjuvants. Vaccination targets infants and children over 3 months of age to prevent infectious diseases caused by meningococcal groups A and C, such as meningitis and pneumonia.
5. Haemophilus influenzae type b conjugate vaccine is purified Haemophilus influenzae type b with capsular polysaccharides and tetanus
Toxoid covalent binding, added aluminum phosphate adjuvant adsorption is made. Children aged 2 months to 5 years are used to prevent invasive infections (including meningitis, pneumonia, sepsis, cellulitis, arthritis, epiglottitis, etc.) caused by Haemophilus influenzae type b.
6. The bivalent conjugate vaccine for Freundhne's dysentery adopts Foo 2a dysentery bacillus and O17 O17 of O17
Serotype cultures, purified dysentery polysaccharides, combined with tetanus toxoids and prepared. Inoculation targets
For children, adolescents and adults over 3 months of age, it is used to prevent bacterial dysentery caused by Shigella fusella serotype 2a and Shigella soongnes infection.
7. The 23-valent pneumococcal polysaccharide vaccine is a polysaccharide vaccine prepared by culture and purification of pod polysaccharides using 23 kinds of pneumococcal serotypes that are most widely prevalent and invasive, and are vaccinated for people over 2 years old to prevent pneumonia, meningitis, otitis media and bacteremia caused by the pneumococcal serotype contained in the vaccine.
Third, the necessity of the project 1, the construction of the project, in line with the needs of industrial policy development. According to the Beijing Municipal Urban Master Plan 2004
-2020" in the principle of industrial development and layout guidance, Zhifei Luzhu in the Beijing Economic and Technological Development Zone to build a vaccine industry base in line with the requirements of the overall planning of Beijing. After the completion of the production base, it can give full play to the advantages of good industrial foundation, good land use conditions and convenient transportation in the southeast direction of Beijing, and play a positive role in accelerating the construction of a high-tech industrial belt with Yizhuang as the core.
2. The construction of the project is in line with the needs of the company's production and development layout:
(1) The existing production base cannot meet the current production needs. Our wholly-owned subsidiary Zhifei Green Bamboo is mainly engaged in business
For the research and development, production and sales of vaccine products, the products currently listed are A group C meningococcal polysaccharide conjugate vaccine, A, C, Y, W135 meningococcal polysaccharide vaccine, AC meningococcus (combined) type b haemophilus influenzae (combined) combined vaccine, haemophilus influenzae type b conjugate vaccine and group A group C meningococcal polysaccharide vaccine, etc., each product is based on various types of meningococcal polysaccharides, Haemophilus influenzae type b polysaccharides as raw materials, is the main and key raw material for the production of finished vaccines, Although the company's vaccine industrialization base has been completed and will soon be put into production, and the production capacity of the production base can reach 38 million doses, the company's existing polysaccharide production workshop and the original finished product workshop are supporting construction, and are now running at full capacity, coupled with aging equipment, limited space and other issues, which cannot meet the polysaccharide dosage demand of the new industrialization base;
(2) Existing production facilities will not be able to meet future production needs. With pneumonia and dysentery and other related vaccines land
Continuing to go public, the company needs more production lines for the production of vaccine polysaccharides. Therefore, the expansion of polysaccharide raw materials production workshop is to enrich the company's product structure, expand the needs of industrial scale, but also to meet the company's development layout in the next 5-10 years of the needs, if the future pneumonia polysaccharide vaccine into the national immunization program, dysentery vaccine through the WHO certification, the project can quickly meet the market demand, which will be conducive to further enhance the company's core competitiveness and enhance the company's sustainable development capabilities, to fully achieve the company's development strategy to create better conditions.
Fourth, the analysis of investment returns
The construction project and the proposed input products meet the requirements of the national and local industrial development orientation, the project products are independently developed, have independent intellectual property rights, and meet the relevant requirements of the National Development and Reform Commission's "Industrial Structure Adjustment Guidance Catalogue" to encourage development. After the completion of the project, it can meet the production requirements of intermediate products A, C, Y, W135 polysaccharides and Hib polysaccharides and Hib polysaccharides of 10 million doses/year of the flow brain and Hib series finished vaccines, and meet the finished pneumonia series epidemics
Seedling 10 million doses / year intermediate products 23 types of pneumococcal polysaccharide production requirements, to meet the dysentery series of finished products
Vaccine 5 million doses / year intermediate product 2 types of dysentery polysaccharide production requires a great increase in the company's production capacity.
V. Analysis of major risks and countermeasures
1. Technology development risks
The research, development and production of biological products is a multidisciplinary highly comprehensive mutual penetration, knowledge-intensive, high-tech content, complex process of high-tech activities, every link of the research and development process is related to the success or failure of research and development, there are high risks. However, the products of this project - pneumonia, dysentery process route design, product quality control and part of the process, are similar and referenced with the company's products, so the company has a great advantage in the development of the product route; at the same time, the relevant products have been in the clinical trial stage, to be phase III clinically completed, its treatment or diagnosis effect is good, after passing the registration approval, it can be put into the market, and its technology development risk is relatively small.
2. Manage risks
The quality and experience of managers, the standardization and soundness of the project management mechanism, the degree of scientific decision-making, and the rationality of the enterprise organization all directly determine the size of the project management risk of new drug development. In addition, due to the imperfect talent evaluation mechanism and incentive mechanism in the development of new drugs, scientific research talents are diverted to the business field, which makes new drug research stranded in the middle, which is also an important part of the project management risk of new drug development. The person in charge of this project has many years of experience in the research and development and management of biological products, and has a high-quality management team, and also resists risks by clarifying the company's purpose and strategic planning, formulating a hierarchical and detailed management plan, strengthening the organization and control in the project implementation process, and improving the quality of employees and improving the management level.
3. Production risk
The supply capacity of raw materials and energy in the development of new drugs, the level of production equipment and processes, the technical level and proficiency of operators, and the degree of satisfaction of production costs have a direct impact on production risks. This project has been the company's quality assurance department (QA) and related functional departments to carry out a full production quality risk assessment, at the same time, the company's quality assurance department management will run through the entire process of production, through risk analysis, assessment, verification, confirmation, etc
A range of methods to reduce risk in the production process.
4. Capital risk
Overdue accounts receivable will directly affect the cash inflow of the enterprise and trigger a financial crisis, which in turn will affect the progress of the project construction. The company has established a strict accounts receivable management system, prevention mechanism and monitoring system, multi-level, multi-link to avoid and reduce the possibility of financial risks.
At the same time, in order to effectively avoid the above risks, the company will take further safeguard measures:
(1) Establish a scientific decision-making system Successfully carry out new drug development projects is inseparable from a scientific decision-making system. In the process of project implementation, it is necessary to ensure the scientific decision-making process and project establishment, fully collect and utilize information, pay close attention to the information of domestic and foreign pharmaceutical development, timely grasp advanced scientific knowledge, and provide a basis for correct decision-making.
(2) Strengthen management
Establish a scientific management and an effective organizational structure to ensure the smooth organization of the project. Regularly evaluate the progress of the project to ensure its progress; implement effective incentives to improve the enthusiasm and creativity of relevant personnel; strengthen communication among project team members, create a good atmosphere of information communication and knowledge sharing, strengthen knowledge complementarity, ability coordination, and teamwork among project members; coordinate the work of various departments and strengthen the prevention of unfavorable factors that cause risks, so as to eliminate defects within the enterprise or organization, and achieve the purpose of preventing and avoiding risks.
(3) The implementation of the project to establish an effective capital guarantee system requires enterprises to invest a lot of money. It is necessary to accurately divide the phases of the project and the resource allocation plan of each stage to meet the funding needs of the project. Combined with the company's capital situation and the budget requirements of R&D projects, we will allocate funds reasonably to ensure the smooth progress of the project and effectively control financial risks.
(4) Strengthen the protection of intellectual property rights
If pharmaceutical companies want to survive and develop in the fierce competition, the key lies in innovative drugs with independent intellectual property rights. Protect property rights through intellectual property rights and prevent intellectual property-related risks. New drug development must comply with the law and use laws and regulations to strengthen the protection of innovative achievements. Enterprises should further improve the internal management system, strengthen the confidentiality system and confidentiality measures, put an end to the improper use or unauthorized leakage of technical achievements by employees, and effectively protect the legitimate rights and interests of the company.
6. Relevant review and approval procedures
1. Deliberation of the board of directors of the company The sixth meeting of the third board of directors of the company deliberated and passed the "Proposal on Using Its Own Funds to Invest in the Construction of polysaccharide Production Workshop", and agreed that the company used its own funds of 318.0959 million yuan for the construction of the production workshop.
This investment and construction is in line with the company's actual production and operation needs, in line with the company's industrial chain layout in the field of vaccines, is conducive to enriching the company's product structure, expanding the industrial scale, enhancing the core competitiveness of enterprises, in line with the relevant provisions of the "Guidelines for the Standardized Operation of Listed Companies on the Growth Enterprise Market of the Shenzhen Stock Exchange", and agrees to submit the project
The company began construction after the approval of the 2015 annual general meeting of shareholders.
2. Opinions of the company's independent directors
As an independent director of the company, we believe that the company's use of its own funds to invest in the construction of Zhifei green bamboo polysaccharide production workshop project is in line with the company's strategic development plan, which is conducive to promoting the company's industrial technology upgrading, improving and enhancing the company's production capacity, and enhancing the company's core competitiveness. The company's investment in the construction of the project has also gone through the necessary approval procedures, in line with the "Shenzhen Stock Exchange GEM Stock Listing Rules", "Shenzhen Stock Exchange GEM Listed Companies Standardized Operation Guidelines" and other relevant provisions, we agreed to the company's investment in the construction of the project.
3. The fourth meeting of the third session of the board of supervisors of the company deliberated and passed the "Proposal on Using Its Own Funds to Invest in the Construction of Polysaccharide Production Workshop", and the Board of Supervisors believes that the use of its own funds to invest in the construction of a polysaccharide production workshop project for human use is in line with the company's long-term development strategy, and also meets the actual business needs of the company, which is conducive to enhancing the core competitiveness of the company.
7. Documents for reference
1. Resolution of the sixth meeting of the third board of directors;
2. Independent Directors' Independent Opinions on Matters Related to the Sixth Meeting of the Third Board of Directors;
3. Resolution of the fourth meeting of the third session of the Board of Supervisors;
The Board of Directors of Chongqing Zhifei Biological Products Co., Ltd. is hereby announced
29 February 2016