Company code: Cansino Biologics Inc(688185) company abbreviation: Cansino Biologics Inc(688185) Cansino Biologics Inc(688185) Jinyu Bio-Technology Co.Ltd(600201) company
Summary of annual report 2021
Section I important tips
1 the summary of this annual report comes from the full text of the annual report. In order to fully understand the company's operating results, financial status and future development plan, investors should go to the website of Shanghai Stock Exchange (www.sse. Com. CN.) The website carefully reads the full text of the annual report. 2. Significant risks: the company has explained the risk factors that may have a significant adverse impact on the company in "IV. risk factors" of "section III Management Discussion and analysis" of this report. Please pay attention to the investment risks. 3 the board of directors, the board of supervisors and the directors, supervisors and senior managers of the company guarantee the authenticity, accuracy and completeness of the contents of the annual report, and there are no false records, misleading statements or major omissions, and bear individual and joint legal liabilities. 4. All directors of the company attended the board meeting. 5 Deloitte Touche Tohmatsu (special general partnership) has issued a standard unqualified audit report for the company. 6. The company is not profitable and has not yet achieved profitability when it is listed □ yes √ No 7. The profit distribution plan or the plan for the conversion of provident fund into share capital in the reporting period adopted by the resolution of the board of directors
According to the rules on share repurchases of listed companies and other relevant provisions, listed companies do not enjoy the right to profit distribution when repurchasing shares in the special account. According to the proposal of the board of directors, it is proposed to distribute a cash dividend of 8 yuan (including tax) for every 10 shares to all shareholders of the company. The company does not convert the capital reserve into share capital and does not give bonus shares. As of March 25, 2022, the total share capital of the company is 247449899 shares, and the total number of shares in the repurchase special securities account is 325000 shares. Based on this calculation, the total cash dividend to be distributed is 1976999920 yuan (including tax). If the distribution plan changes due to the listing of new shares, share repurchase and other matters during the period from the disclosure to the implementation of the distribution plan, the total amount of distribution will be adjusted based on the total share capital on the equity registration date of the future implementation of the distribution plan, and the specific adjustment will be announced separately. The profit distribution plan can be implemented only after being deliberated by the general meeting of shareholders of the company. 8. Whether there are important matters such as special arrangements for corporate governance □ applicable √ not applicable
Section II basic information of the company
1 company profile company stock profile √ applicable □ not applicable
Company stock profile
Stock type stock exchange stock abbreviation before stock code change stock abbreviation and sector
A-share Shanghai Stock Exchange Cansino Biologics Inc(688185) -u Cansino Biologics Inc(688185) none
Scientific innovation board
H-share stock exchange of Hong Kong Cansino Biologics Inc(688185) biology-b 06185 none
Ltd motherboard
Profile of the company's depositary receipts □ applicable √ not applicable contact person and contact information
Contact person and contact information secretary of the board of directors (domestic representative of information disclosure) securities affairs representative
Name Cui Jin-
Office address: No. 185, South Street, West District, Tianjin Economic and Technological Development Zone-
Western District Biomedical Park
Tel: 02258213766-
E-mail [email protected]. -
2. Introduction to the company's main business in the reporting period (I) main business, main products or services
The company is an innovative vaccine enterprise committed to R & D, production and commercialization in line with Chinese and international standards. Under the leadership of the management, the company has launched a series of research and development of innovative vaccines. The R & D pipeline covers a variety of clinical vaccine varieties that can prevent COVID-19 pneumonia, Ebola virus disease, meningitis, DPT, pneumonia, tuberculosis and herpes zoster. As of the disclosure date of this report, the recombinant New Coronavirus vaccine (type 5 adenovirus vector) has been authorized by many countries in China and abroad for emergency use / conditional listing. The recombinant Ebola virus vaccine (adenovirus vector) has completed the registration of new drugs, and two meningococcal vaccine products have obtained the drug registration certificate, while the 13 valent pneumococcal conjugate vaccine, DPT vaccine and tuberculosis enhanced vaccine are in the clinical trial stage.
The company has gradually developed 17 innovative vaccine products for the prevention of Ebola virus disease, meningitis, COVID-19 pneumonia, DPT, pneumonia, tuberculosis and herpes zoster. The following are the details: 12
No. progress of vaccine product indications by the end of the reporting period
1 Ad5 ncov covid-19 pneumonia has obtained emergency use authorization / conditional listing from many countries at home and abroad
2. Ad5 EBOV Ebola virus disease has obtained the new drug certificate and production number
3 mcv2 meningococci has obtained the drug registration certificate
Meningococcal V4 drug registration certificate obtained
5. The clinical phase I / II trial of Ad5 ncov covid-19 pneumonia for inhalation has been completed
6 pcv13i pneumococci is undergoing phase III clinical trial
7 PBPV pneumococci have completed clinical phase ia trial
8. The clinical phase I trial of DTCP for infants has been completed
9. The phase I clinical trial of DTCP enhanced vaccine DPT has been completed
10 clinical application of tdcp for teenagers and adults
11 TB enhanced vaccine tuberculosis has completed phase I phase B trial.
Preclinical study of 12 mRNA covid-19 vaccine covid-19 pneumonia
Preclinical study of adenovirus vaccine
Preclinical study of 14 combined vaccines DPT and influenza B Haemophilus
bacillus
Preclinical study of meningococcal meningitis vaccine group 15 B
Preclinical study of herpes zoster vaccine
17. Preclinical study of polio vaccine
（2） Main business model
1. R & D mode
The research and development mode of the company is mainly independent research and development, and extensive foreign cooperation is carried out.
Independent R & D means that the internal R & D team participates in all stages of product R & D, from early POC research, process development, determination of quality standards, pharmacodynamics research and safety evaluation to clinical trials, submits NDA application materials and obtains new drugs. Cooperative research and development means that the company cooperates with research institutions at home and abroad to develop innovative vaccines through technical cooperation. The institutions that have established cooperative relations with the company include the Institute of bioengineering of the Academy of Military Sciences, the National Research Council of Canada (NRC), McMaster University, bird-c GmbH and vaccine Limited.
2. Procurement mode
The raw materials purchased by the company mainly include culture medium raw materials, pharmaceutical excipients, clinical trial control vaccines and other R & D reagent consumables. The procurement plan shall be updated semi annually and adjusted quarterly. The procurement Planner of the supply chain procurement department shall summarize the procurement needs of each department according to the production plan and Department planning, and formulate the procurement plan of this quarter. The procurement can be carried out only after being reviewed level by level by the preparer, the head of the procurement department, the supply chain director, the head of the finance department, the chief operating officer and the chief executive officer. The company standardizes the procurement process of industrialization base construction projects, the procurement process of production materials, the daily procurement, warehousing acceptance and payment process of non production materials through the procurement management procedures, inquiry and bidding process and other systems.
3. Production mode
The State implements a strict access system for vaccine production. According to the vaccine administration law, the vaccine marketing license holder shall have the vaccine production capacity; If it is really necessary to entrust production beyond the production capacity of vaccine, it shall be approved by the drug regulatory department under the State Council. The company will build high-specification workshops meeting GMP requirements and configure corresponding advanced equipment. In the future, the production plan will be formulated according to the product R & D progress, commercialization strategy, market arrangement and the specific production situation of the company, and the production department will be arranged for production.
4. Sales model
During the reporting period, the company adjusted and established a commercial operation center, which consists of China and international marketing department, strategic marketing department, operation Department, brand communication department, commercial supply department and vaccine circulation quality department. By the end of the reporting period, the company had 232 sales personnel. With the commercialization of products, the company will continue to expand its sales team, build an efficient cold chain logistics supplier network, and cooperate with professional partners in the industry to promote products (if necessary) to provide high-quality vaccine products for the Chinese people.
Meanwhile, the company has signed a promotional service agreement with Pfizer Investment Limited, authorized its exclusive promotion of MCV4 vaccine product in the Chinese mainland. ®。 The signing of the agreement shows that multinational pharmaceutical companies recognize the competitiveness, technical strength and product quality of their products. It is also manhaixin ® The successful commercialization of the company provides a guarantee for the establishment of the company's brand and the establishment of a marketing system in line with international standards.
（3） 1.1 industry Development stage, basic characteristics and main technical threshold of the industry
(1) Industry and basic characteristics of the company
The company is currently engaged in the research, production and commercialization of vaccines. The main products are recombinant New Coronavirus vaccine (type 5 adenovirus vector), meningococcal vaccine, recombinant Ebola virus vaccine (adenovirus vector), DPT vaccine, pneumococcal conjugate vaccine, tuberculosis enhanced vaccine, etc.
According to the guidelines for Industry Classification of listed companies, the industry of the company is "pharmaceutical manufacturing industry (Code: C27)"; According to the industrial classification and code of national economy, the industry of the company is "genetic engineering drug and vaccine manufacturing (Code: c2762)" of "pharmaceutical manufacturing industry (Code: C27)"; According to the classification of strategic emerging industries (2018), the company's industry is "genetic engineering drug and vaccine manufacturing" of "biological drug product manufacturing".
Vaccine is a milestone in the history of human medicine and the main means of controlling infectious diseases. It is regarded as one of the greatest public health achievements in the 20th century. The development of vaccine has experienced many technological revolutions, and the vaccine industry is becoming more and more mature. As early as the 12th century, China used smallpox vaccination to prevent smallpox. In the 18th century, cowpox vaccination appeared in Britain to prevent smallpox. Vaccine has become an immune method and entered the field of human medicine. From the late 19th century to the early 20th century, French scientist Pasteur invented the live attenuated vaccine technology and developed rabies vaccine, BCG vaccine and other products that are still in use today. Since the middle of the 20th century, polysaccharide protein combined vaccine and protein component vaccine have become one of the important achievements in the history of vaccine development. Since the 1970s, with the development of molecular biology, human beings can operate the genes of microorganisms at the molecular level, and invented the technology of gene recombinant vaccine. After the 21st century, with the development of genomics, human beings began to develop a genome-based vaccine strategy.
After years of development of the vaccine industry, the global vaccine industry pattern and China's vaccine industry pattern are also evolving. Before 2000, due to the long R & D cycle, large investment and high risk of vaccines, and the lack of long-term use of chronic disease treatment drugs, most pharmaceutical enterprises did not have high enthusiasm to invest in vaccines. After 2005, large pharmaceutical enterprises such as GlaxoSmithKline, Pfizer, Sanofi and Johnson & Johnson entered the vaccine market through mergers and acquisitions, and rapidly expanded their product lines and increased the size of the company by purchasing product patents and enterprise control. Before the outbreak of covid-19, the market concentration of the four vaccine giants GlaxoSmithKline, MSD, Pfizer and Sanofi was quite high. Compared with the monopoly pattern of vaccine industry giants in the world, China's market pattern is relatively scattered because China's vaccine industry has entered the market in less than 20 years. In 1989, the Ministry of health integrated and established the central epidemic prevention Office in the era of planned economy and six local research institutes (Beijing, Shanghai, Wuhan, Chengdu, Changchun and Lanzhou Institute of biological products)
