Company code: Xiamen Amoytop Biotech Co.Ltd(688278) company abbreviation: Xiamen Amoytop Biotech Co.Ltd(688278) Xiamen Amoytop Biotech Co.Ltd(688278)
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 http://www.sse.com.cn. The website carefully reads the full text of the annual report. 2 major risk tips
The company has elaborated the possible risks and Countermeasures in the business process in this report. Please refer to “IV. risk factors” in Section III “management discussion and analysis” of the 2021 annual report for relevant contents. 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 Rongcheng Certified Public Accountants (special general partnership) 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
The company’s profit distribution plan for 2021 is: Based on the total share capital on the registration date of dividends and dividends, the company plans to distribute cash dividends of RMB 1 (including tax) to all shareholders for every 10 shares, without converting capital reserve into share capital and bonus shares. As of December 31, 2021, the total share capital of the company is 406800000 shares. Based on this calculation, the total cash dividend to be distributed is 40680000 yuan (including tax). The above profit distribution plan has been deliberated and approved at the sixth meeting of the eighth board of directors of the company, and can be implemented only after it is submitted to the general meeting of shareholders for deliberation and approval. 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 Xiamen Amoytop Biotech Co.Ltd(688278) Xiamen Amoytop Biotech Co.Ltd(688278) not applicable
Scientific innovation board
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: Sun Zhili, Liu Peiyu
Office address: No. 330, wengjiao Road, Xinyang Industrial Zone, Haicang, Xiamen
Tel: 05926889118
E-mail [email protected]. [email protected].
2. Introduction to the company’s main business in the reporting period (I) main business, main products or services
1. Main business of the company
The company is an innovative biomedical enterprise mainly engaged in the R & D, production and sales of recombinant proteins and long-acting modified drugs. Taking immune related cytokine drugs as the main research and development direction, the company is committed to becoming the leader of systemic immune solutions based on cytokine drugs, and providing better solutions for the treatment of major diseases such as viral hepatitis and malignant tumors. In the next few years, the company will focus on the clinical cure of chronic hepatitis B, and continue to promote the progress of clinical research in many research projects. 2. Main products of the company
At present, the company has listed four products, namely pegbin, telli, teljin and telkang. The basic information is as follows:
(1) Gerpin
Pegylated interferon α- 2B injection) is the first 40KD pegylated interferon in the world α- 2B injection is a national class 1 new drug of biological products for treatment. The drug has completely independent intellectual property rights and has been granted patents by China, Europe, the United States, Japan and other countries. Drug research and development and related clinical applications have been continuously supported by four major national science and technology projects of “major new drug creation” in the eleventh five year plan, the Twelfth Five year plan and the thirteenth five year plan.
Based on the dual effects of inhibiting virus replication and enhancing immunity, pegylate is mainly used for the treatment of viral hepatitis clinically. It is the first-line drug for the antiviral treatment of chronic hepatitis B recommended in the 2019 edition of China’s guidelines for the prevention and treatment of chronic hepatitis B α- 2b is the current national medical insurance catalogue (class B). Currently, a series of research work has been carried out in the clinical cure and prevention of liver cancer in patients with chronic hepatitis B. China has supported the project of “Chinese chronic hepatitis B clinical cure (Mount Everest)” launched by the China Hepatitis Prevention Foundation. A series of real-world research projects, including “lowering the incidence of liver cancer in China,” and “China’s chronic hepatitis B nucleoside treatment of low viremia” (unnamed) project, will contribute to improving the clinical cure rate of chronic hepatitis B, reducing the risk of liver cancer and achieving a higher therapeutic target for chronic hepatitis B.
(2) Terzin
Terzine (common name: human granulocyte stimulating factor injection), mainly used to treat neutropenia after tumor chemotherapy, won China National Chemical Engineering Co.Ltd(601117) pharmaceutical industry excellent brand of biological and biochemical products. Human granulocyte stimulating factor is the current national medical insurance catalogue (class B) variety. The company is the raw material provider of the national standard substance of this variety, and participates in the development and collaborative calibration of the national standard substance. In addition, the company has participated in the collaborative calibration of human granulocyte stimulating factor standards organized by the United States Pharmacopoeia Commission (USP), the World Health Organization (who) and other international institutions for many times.
According to the standardized management guidelines for tumor chemoradiotherapy related neutropenia issued by the Chinese society of Clinical Oncology (CSCO) in 2021, human granulocyte stimulating factor drugs are one of the main drugs to prevent tumor chemoradiotherapy related neutropenia, which have important clinical application value and broad application prospects.
(3) Telli
Terli (common name: human granulocyte macrophage stimulating factor for injection) is mainly used for: ① treating and preventing leukopenia caused by tumor radiotherapy or chemotherapy; ② Treatment of bone marrow hematopoietic dysfunction and myelodysplastic syndrome; ③ Prevent potential infection complications caused by leucopenia; ④ Accelerate the recovery of neutropenia caused by infection.
Telli is the first listed human granulocyte macrophage stimulating factor drug in China, and it is the achievement of the national key Torch Program. Human granulocyte macrophage stimulating factor is a variety of the current national medical insurance catalogue (class B). The company is the raw material provider of the national standard material of this variety, and participates in the development and collaborative calibration of the national standard.
As an important immunomodulator in tumor treatment, telli has shown its value in tumor immunotherapy in a number of clinical studies. Through a series of academic research, the company continues to consolidate the differentiated competitive advantage of products and improve the recognition of products by experts and patients.
(4) Telcon
Terkang (common name: human interleukin-11 for injection) is mainly used for the treatment of grade III and IV thrombocytopenia after chemotherapy in solid tumors and non myeloid leukemia. Human interleukin-11 is the current national medical insurance catalogue (class B) variety. The company is the raw material provider of the national standard substance of this variety, and participates in the development and collaborative calibration of the national standard substance.
According to the Chinese expert consensus on the prevention and treatment of thrombocytopenia caused by lymphoma chemotherapy issued by the Chinese society of Clinical Oncology (CSCO), human interleukin-11 is the main drug for the treatment of thrombocytopenia caused by lymphoma chemotherapy. According to the recommendation of the expert diagnosis and treatment consensus of tumor chemotherapy-related thrombocytopenia in China issued by the China Anti Cancer Association, human interleukin-11 is one of the main treatment methods of tumor chemotherapy-related thrombocytopenia. （2） Main business model
The company is a national innovative biomedical enterprise mainly engaged in the R & D, production and sales of recombinant protein drugs. It has an independent and complete R & D, procurement, production and marketing system.
1. R & D mode
Based on the characteristics of recombinant protein drugs, the development trend of life cycle management and regulatory requirements, the company has constructed a complete innovative drug R & D system, covering drug upstream technology development, downstream technology development, quality and drug formation research, preclinical and clinical research and industrialization research. In specific R & D activities, innovative drugs are developed with the support of core technology platform and project management mode; At the same time, the company continues to pay attention to the development of new targets and new mechanism drugs, constantly enrich the company’s product line and continuously improve its core competitiveness.
2. Procurement and production mode
According to the internationalization strategy and the needs of the industrialization of innovative products, referring to the European and American GMP norms, the company uses the concept of quality from design (QBD) and quality risk management means to strictly implement the requirements of the national GMP norms, national drug quality standards, registration standards and other mandatory standards.
3. Marketing model
The company mainly adopts the sales mode of combining dealers and professional academic promotion. According to the relevant laws and regulations and product characteristics, the distribution mode is selected, and the pharmaceutical dealers with good reputation and strong strength are selected to distribute relevant drugs to the hospital according to the accessibility of their distribution area, which provides a strong guarantee for the quality of drug distribution service and the recovery of accounts receivable; In addition, according to the high technical content of biological drugs, the marketing department of the company is responsible for introducing the pharmacology, indications, use methods, safety and the latest clinical research results of the company’s drugs to the market through academic promotion, and exploring treatment schemes in different fields. （3） Industry 1 Development stage, basic characteristics and main technical threshold of the industry
(1) Industry development stage
In recent years, the global pharmaceutical industry is facing complex and profound changes. Covid-19 epidemic has increased the importance of biomedicine, and local governments continue to increase investment in biomedicine. According to the statistics of evaluatepharma, the proportion of biotechnology drug sales in the overall sales of the global pharmaceutical industry increased from 19% to 34% from 2012 to 2021. Meanwhile, evaluatepharma also predicted that the global prescription drug sales will continue to grow rapidly from 2021 to 2026, and the proportion of biotechnology drug sales in global drug sales will continue to rise to 37% by 2026; Most of the top 100 drugs with the highest global sales belong to biotechnology drugs, accounting for 57% of the total sales of the top 100 drugs. On the whole, the pharmaceutical industry continued to recover after the normalization of epidemic prevention and control in 2021, showing a good industry development momentum.
(2) Basic features and main technical threshold
The pharmaceutical industry is a knowledge intensive, multi-disciplinary and highly integrated emerging industry. It has the characteristics of high investment, long cycle and high risk. The research and development, industrialization and market development of new products need high-level professionals and technology as support. Once the new products are successfully developed, it may form a technological monopoly advantage and improve the competitiveness of enterprises.
Based on the above characteristics, the pharmaceutical industry has high barriers in R & D technology, talent reserve and financial strength, and the listing of innovative drugs needs strict approval. After listing, it usually needs to face a series of difficulties, such as medical insurance catalog access, centralized (online, negotiation) procurement, medical institution access and clinician recognition. At the same time, with the gradual deepening of China’s medical reform and the normalization of centralized volume procurement and medical insurance negotiation, the pharmaceutical industry presents more and more strict regulatory requirements, which promotes the orderly competition and survival of the fittest in the industry to a certain extent, and pushes up the entry threshold of the industry. 2. Analysis of the company’s industry position and its changes
The company is a leading enterprise in the field of polyethylene glycol protein long-acting drugs in China. Since its establishment, the company has always prospectively arranged and built an innovative platform covering the expression, long-acting modification and industrialization of a variety of protein drugs around the field of major disease treatment. According to the Chinese medicine biopharmaceutical volume of China Meheco Group Co.Ltd(600056) statistical annual report in 2020, the main business income of the company in the biological and biochemical products industry ranks among the top 50, which is at the upper level of the industry. The company closely follows the industry drug R & D trend and technology development trend, continues to promote a number of drug R & D, and five polyethylene glycol protein long-acting drugs have been approved to carry out clinical research. At the same time, the company actively promoted its products. During the reporting period, the market share of the company’s mature products continued to be in the leading position in the segment market and had strong market competitiveness.
The company’s existing products are divided into infection line and blood tumor line, specifically:
(1) Infection line product: pegbin
Pegylated interferon α- 2B injection) was approved to market in 2016. It is the first long-acting interferon product with completely independent intellectual property rights in China, which is mainly used in the field of viral hepatitis. The listing of patby has broken the monopoly of foreign pharmaceutical enterprises on China’s hepatitis B treatment drugs, and achieved import substitution. Its drug development and related clinical applications have been supported by 4 major national science and technology projects, which are “major new drugs”. They have original structural design and complete patent protection. They were selected as the ten major progress of China Meheco Group Co.Ltd(600056) biotechnology in the year of China Meheco Group Co.Ltd(600056) Biotechnology Association. In addition, the chronic hepatitis B clinical cure registration clinical trial conducted by the company is the first clinical trial of long acting interferon registration for the purpose of clinical cure. It belongs to a large sample, randomized controlled trial and high level of evidence. Future research results will enhance evidence-based medical evidence for clinical cure of chronic hepatitis B, and further enhance the depth of application of pegbin in the field of chronic hepatitis B treatment.
Currently, long acting interferon products approved for chronic hepatitis B in China are only three products of pelpie, Roche and MSD, which are mainly distributed in the China market. With the continuous deepening of application of PGB in the treatment of chronic hepatitis B, sales revenue continues to grow.
(2) Blood tumor line
