Securities code: Fujian Cosunter Pharmaceutical Co.Ltd(300436) securities abbreviation: Fujian Cosunter Pharmaceutical Co.Ltd(300436) Announcement No.: 2022038 Fujian Cosunter Pharmaceutical Co.Ltd(300436) summary of 2021 Annual Report
1、 Important note: 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 carefully read the full text of the annual report in the media designated by the CSRC. In addition to the following directors, other directors attended the meeting of the board of directors to consider the annual report in person
Name of director not present in person position of director not present in person reason for not attending the meeting name of the entrusted person
The audit opinion of Dahua Certified Public Accountants (special general partnership) on the company's financial report this year is: standard unqualified opinion. Changes of accounting firm during the reporting period: the accounting firm of the company changed from to Dahua accounting firm (special general partnership) this year. Tips of non-standard audit opinions □ applicable √ not applicable when the company is listed and is not profitable at present □ applicable √ not applicable to the profit distribution plan of ordinary shares or the plan of converting accumulation fund into share capital in the reporting period considered by the board of directors □ applicable √ not applicable. The company plans not to distribute cash dividends, bonus shares or convert accumulation fund into share capital. Preferred stock profit distribution plan for the reporting period adopted by the board of directors □ applicable √ not applicable II. Basic information of the company 1. Company profile
Stock abbreviation Fujian Cosunter Pharmaceutical Co.Ltd(300436) stock code Fujian Cosunter Pharmaceutical Co.Ltd(300436)
Shenzhen Stock Exchange
Contact person and contact information secretary of the board of directors securities affairs representative
Name: Lin Xiaohui, Wang Qin
Office address: Block B, block B, block 10, block B, block B, software park, block 89, software Avenue, Gulou District, Fuzhou City, Fujian Province
Fax: 059138305364
Tel: 059138305333
E-mail [email protected]. [email protected].
2. Introduction to main business or products during the reporting period
(I) Business Overview
The 20th anniversary of the founding of . Over the past 20 years, Fujian Cosunter Pharmaceutical Co.Ltd(300436) has never forgotten its original intention, not afraid of thorns, continued to innovate, complied with the general trend of the pharmaceutical industry, prospected the layout, and practiced the transformation from generic drugs to innovative drugs. Bearing in mind the mission of the enterprise, the company has assisted in the localization of generic drugs, established an innovation and development strategy, and gradually has a certain first mover advantage in the field of innovative drugs. At the same time, adhere to the combination of imitation nurturing and imitation innovation, focus on endogenous growth and go hand in hand with epitaxial expansion, constantly enrich the company's product pipeline and optimize the product structure, and firmly move forward to a leading innovative drug enterprise in the field of antiviral and liver health drugs. In 2021, Fujian Cosunter Pharmaceutical Co.Ltd(300436) bucked the trend, made innovations, and continuously consolidated the foundation for development. The company adheres to seeking development through innovation, speeds up the progress of clinical research and development of innovative drugs, actively promotes the listing progress of generic drugs under research, strengthens team construction, promotes the promotion and sales of new and old generic drugs, and implements the practice of nurturing innovation through imitation; Kone has completed the issuance to specific objects, actively introduced talents, promoted the construction of investment projects with raised funds, and helped the transformation, upgrading and long-term development of the company. In 2021, the company realized an operating revenue of 370442200 yuan, basically the same as that of the same period of the previous year. However, due to the impact of factors such as the large increase of R & D expenses, the enhancement of team construction and the delivery of headquarters building, the related expenses increased year-on-year, resulting in a loss and a net profit of -348866 million yuan (if the impact of R & D investment is deducted, the company will realize profit). During the reporting period, the company mainly carried out the following key work:
(1) Continue to increase R & D investment and promote the progress of innovative drug R & D
During the reporting period, the company firmly implemented the innovation and development strategy and accelerated the research and development progress of innovative drugs. The research and development cost was 689895 million yuan, an increase of 215176 million yuan year-on-year. Strategic layout against New Coronavirus small molecule oral Innovation Medicine GST-HG171, integration of resources to promote, and strive to early listing for the contribution of anti epidemic, has identified the preclinical candidate compound PCC, is accelerating pre clinical research. The experimental results of its in vivo and in vitro model efficacy and covid-19 euvirus activity showed that gst-hg171 was effective against various known major virus strains (original strain, beta variant strain, Delta, Omicron, etc.). The c-met targeted drug gst-hg161 project has completed the phase I clinical trial, dose increasing phase trial, and the overall safety is good. At present, the phase IB multi center extended phase trial is being carried out. Taking Shanghai Dongfang Hospital as the center, the clinical research is carried out jointly with three sub centers of Shanghai Pulmonary hospital, Fujian cancer hospital and Linyi cancer hospital. Hepatitis B treatment Innovation Medicine China GST-HG141 has completed the Ia phase clinical trial, the overall safety is good, the Ib phase clinical trial results are positive, showing that GST-HG141 has good safety and pharmacodynamics and pharmacokinetic characteristics for Chinese chronic hepatitis B patients, supports GST-HG141 to continue the II clinical trial, has obtained the clinical II phase clinical trial ethics committee approval, is preparing for the phase II clinical trial. The Ia phase GST-HG131 trial of hepatitis B treatment innovation medicine has completed the observation of drug tolerance and safety of all subjects. The first subject of the phase I clinical trial of gst-hg151, a new drug for the treatment of nonalcoholic steatohepatitis and liver fibrosis, was successfully enrolled on March 11, 2022. Hepatitis B treatment Innovation Medicine GST-HG121 is currently actively promoting the preparatory work for phase I clinical trials.
(2) Spin off and set up a subsidiary of innovative drugs to professionally manage and operate
During the reporting period, the company jointly initiated the establishment of Fujian Guangsheng Zhonglin Biotechnology Co., Ltd., a subsidiary of innovative drugs, with five innovative drugs under research (gst-hg161, gst-hg151, gst-hg141, gst-hg131 and gst-hg121) and monetary capital contribution and core employee stock ownership platform, to manage innovative drugs and generic drugs separately, give better play to the advantages of professional operation and management, improve incentive mechanism and attract excellent professionals, Accelerate the process of project development and listing of innovative drugs, and further enrich the company's innovative drug R & D pipeline.
By vigorously introducing innovative talents, Guangsheng Zhonglin is constantly improving the construction of innovative drug R & D and management team. Dr. George Zhang (Zhang Yuhua), who has rich experience in innovative drug R & D, product pipeline layout and expansion, has been appointed as the general manager. He and Dr. John Wei Zhong Mao, the chief scientist, jointly lead the innovative drug team and accelerate the R & D process of innovative drug projects, Ensure the smooth implementation of the company's innovation strategy.
(3) Complete the refinancing issuance and orderly promote the construction of raised investment projects
The company obtained the reply on Approving the registration of Fujian Cosunter Pharmaceutical Co.Ltd(300436) issuing shares to specific objects (zjxk [2020] No. 2748) in October 2020, and completed the issuance of 18777000 shares to specific objects in June 2021. The total amount of funds raised was 51448980000 yuan. After deducting the issuance expenses excluding tax of 1490566038 yuan, the net amount of funds actually raised was 49958413962 yuan, and the new shares were listed on July 9, 2021. In combination with the phased needs of the development strategy, the company makes reasonable planning, orderly promotes the construction of investment projects with raised funds, further improves the company's pharmaceutical manufacturing capacity and promotes innovation transformation, strengthens the research and development of innovative drugs, and improves the company's innovation ability and sustainable development ability. The construction of the high-quality project of the company's international preparation and API fund-raising investment project is progressing smoothly. It is expected to apply for GMP certification in June 2022. At the same time, the company is also scientifically planning and deploying covid-19 drug production capacity to market large-scale production of innovative drugs such as covid-19 gst-hg171 and consolidate the foundation of modern hardware production!
(4) Expand high-quality imitation varieties and further enrich product pipelines
During the reporting period, the company effectively expanded and enriched the product pipeline, and successively approved the best-selling generic drugs in the fields of liver disease, cardiovascular tube and men's health, such as entecavir tablets (Doctor GaN), propofol tenofovir tablets (tegantine), sildenafil tablets (jingo), rivaroxaban tablets (tonoan) and pivastatin calcium tablets (chinoan), Among them, rivaroxaban tablets (tonoan) won the bid for the fifth batch of national centralized procurement of drugs, providing the company with new revenue and profit growth points. At the same time, the company signed the strategic cooperation framework agreement with Fujian ruitailai Pharmaceutical Technology Co., Ltd., a high-end preparation technology R & D enterprise, to reach a strategic partnership, continuously enrich the company's high-end difficult to imitate drug product pipeline with high clinical value and strong market demand, promote the optimization and upgrading of the company's product structure, build product differentiated competitive advantages, and enhance the company's core competitiveness in the pharmaceutical field.
(5) Continuously strengthen team building and promote new product sales
At the beginning of the reporting period, the company focused on strengthening the sales management system of the division system, strengthening the team construction of the liver disease division, establishing a new retail division and e-commerce division, and improving the promotion ability of professional chemistry; Actively explore new sales models and promote the sales of newly approved products; At the same time, in order to increase the market coverage, the company signed a strategic cooperation agreement with Shanghai Pharmaceutical Holding Co., Ltd. in June 2021, focusing on its advantages and helping the company's products quickly improve the market share with the help of its resource advantages in the fields of Commerce, hospital, retail, B2B / o2o and so on. (II) product pipeline
China's Chinese China's mission of "broadcasting humanity and caring for people's livelihood" is a firm commitment to providing scientific solutions for human liver health. We are committed to promoting innovative drug research and development, implementing innovative development strategies, and working to create innovative drugs for Chinese people to fight COVID-19 virus, hepatitis B, liver cancer and liver fibrosis.
Through independent research and development, cooperative development and industry mergers and acquisitions, the company has formed a core line of hepatitis B, hepatitis C, hepatitis B, fatty liver, liver fibrosis, liver cancer, liver protection and liver health products, and has actively expanded the cardiovascular, male health, anti COVID-19 virus products. In the future, the company will continue to promote the innovation and development strategy through the combination of imitation nurturing and imitation innovation, adhere to the combination of endogenous growth and epitaxial expansion, constantly enrich the company's product pipeline and optimize the product structure, and strive to become a leading innovative drug enterprise in the field of antiviral and liver health drugs.
1. Generic pharmaceutical field
1.1 marketed products
(1) anti HBV drugs
Hepatitis B and Nuo Fuwei hepatitis tablets and genten-entecavir tablets were approved for sale during the reporting period. The company has become a high-tech company with five nucleoside (acid) drugs, including China's propofol, Nuo Fuwei, Nuo Fuwei, entecavir, lamivudine and adefovir dipivoxil, and the five major nucleoside (anti acid) anti hepatitis B drugs products have passed the consistency evaluation smoothly. It has greatly enhanced the competitive advantage of the company's market sales, accelerated the import substitution of generic drugs for the original research, and provided patients with high-quality and high-price drug choices. Among them, propofol tenofovir, tenofovir and entecavir are the first-line drugs unanimously recommended by national guidelines for the prevention and treatment of chronic hepatitis B. Propofol tenofovir, tenofovir, entecavir, lamivudine and adefovir dipivoxil were included in the drug catalogue of national basic medical insurance, industrial injury insurance and maternity insurance in 2021.
The company actively participates in the centralized procurement of national drugs, so as to improve the market share of products. In September 2019, entecavir capsule of the company won the bid in the centralized procurement of drugs in 25 regions such as Shanxi, Inner Mongolia, Liaoning, Jilin, Heilongjiang, Jiangsu and Zhejiang organized by the joint procurement office, which has been implemented since December 2019; In January 2020, the company successfully won the bid for adefovir dipivoxil tablets in the second batch of national centralized drug procurement, which has been implemented since April 2020.
(2) Liver protecting drugs
ZTE pharmaceutical, a holding subsidiary of the company, is one of the largest manufacturers of silymarin preparations in China. Silybin drugs, as a kind of natural plant liver protecting drugs recognized all over the world, can protect and stabilize hepatocyte membrane, improve liver detoxification ability and promote hepatocyte regeneration. It is an effective drug for the treatment of hepatitis. It is widely used in the field of liver protection and liver protection. It is a clear guideline drug in the guidelines for the prevention and treatment of chronic hepatitis B and the guidelines for the diagnosis and treatment of drug-induced liver injury. ZTE pharmaceutical silybin meglumine, Yiganling tablets, compound Yiganling tablets and other drugs continue to be included in the 2021 edition of the national catalogue of drugs for basic medical insurance, industrial injury insurance and maternity insurance.
In addition to being popular in the traditional field of liver protection and liver protection, silybin meglumine tablets have also gradually been found in the field of combined drugs. In recent years, silybin meglumine tablets have been used in combination with liver protection products in the treatment of many diseases such as anti tuberculosis and psychotherapy, and achieved good results.
(3) Male health drugs
During the reporting period, the company's Jingge sildenafil citrate tablets (commonly known as "Viagra") were approved for listing. On April 13, 2022, the company's Jiuge tadalafil tablets were approved for listing, forming an effective supplement to the company's products in the field of liver health. Sildenafil and tadalafil are two mainstream drugs for the treatment of erectile dysfunction (ED). They are the two products with the largest market scale of ED, and retail pharmacies are their main sales channels.
(4) Cardiovascular drugs
The company strategically laid out its product line in the cardiovascular field. During the reporting period, it successively became the listing license holder of rivaroxaban tablets and pivastatin calcium tablets, further enriching the company's product pipeline. Rivaroxaban and pivastatin were included in the 2021 edition of the national catalogue of drugs for basic medical insurance, work injury insurance and maternity insurance.
Rivaroxaban tablets is a core drug for the prevention of venous thromboembolism, which is pointed out by authorities such as the Chinese guidelines for the prevention and treatment of tumor related venous thromboembolism (2019 Edition) and the Chinese guidelines for the prevention of venous thromboembolism in major orthopaedic surgery (2016 Edition)
