Securities code: Tellgen Corporation(300642) securities abbreviation: Tellgen Corporation(300642) announcement No.: 2022020 Tellgen Corporation(300642) 2021 annual report summary
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. All directors attended the meeting of the board of directors to consider this annual report in person. The audit opinion of Lixin Certified Public Accountants (special general partnership) on the company’s financial report this year is: standard unqualified opinion. Accounting firms in the reporting period: the accounting firm of the company this year is Lixin Accounting firm (special general partnership). Tips of non-standard audit opinions □ applicable √ not applicable to the company’s non-profit at the time of listing and non-profit at present □ applicable √ not applicable to the profit distribution plan of ordinary shares or the plan of converting provident fund into share capital in the reporting period reviewed by the board of directors √ applicable □ not applicable the profit distribution plan of ordinary shares reviewed and approved by the board of directors is: the profit distribution plan of the company after deducting the repurchase of shares in the special account from the total share capital of the company on the equity registration date when the distribution plan is implemented in the future Taking the total number of shares of the company as the base, the company will distribute a cash dividend of 2.50 yuan (including tax) to all shareholders for every 10 shares, give 0 bonus shares (including tax), and increase 0 shares for every 10 shares to all shareholders with capital reserve. 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 Tellgen Corporation(300642) stock code Tellgen Corporation(300642)
Shenzhen Stock Exchange
Contact person and contact information secretary of the board of directors securities affairs representative
Name: Wang Xiaoqing, Hu Chunyang
Office address: Building 1, Lane 115, building 1, Lane 115, Lane 572, Bibo Road, China (Shanghai) pilot Free Trade Zone
Fax: 86-2150270390
Tel: 86-2150495115
E-mail [email protected]. [email protected].
2. Introduction to main business or products during the reporting period (I) overview of main business
The company is mainly engaged in the R & D, production and sales of its own brand in vitro diagnostic products. At present, the products mainly involve multiple series of products with the main application directions of tumor whole process detection, autoimmunity, cardiovascular disease, pathogen infection and reproductive health. The company’s main business has not changed during the reporting period. By the end of the reporting period, the company’s products have covered more than 1500 end users in 31 provinces and cities across the country, and are widely used in hospitals, physical examination centers and independent laboratories at all levels in China. Among them, class III hospitals account for 70.96% of hospital customers and are the main end users of the company; At the same time unfashionable “produce 101”, and continue to explore overseas markets, actively expand overseas distribution channels, and have established solid cooperative relations with overseas distributors, and strive to become a company with international influence in the field of life health technology. During the reporting period, the company achieved a total operating income of 654588600 yuan, an increase of 33.70% over the same period of last year; The net profit was 1610579 million yuan, an increase of 33.60% over the same period last year; The net profit attributable to the shareholders of the parent company was 1610828 million yuan, an increase of 33.62% over the same period last year.
The company’s products can be divided into three categories: immune, molecular and biochemical diagnostic products. The company has developed in vitro diagnostic reagents by comprehensively using high-throughput fluorescence technology, chemiluminescence immunoassay technology, multi-color fluorescence PCR technology and other technical platforms, forming a rich product line of “focusing on clinical detection of the whole course of tumor, supplemented by detection products in other fields”, covering all links of the whole course of tumor “disease free screening – auxiliary diagnosis – personalized medication – prognosis and efficacy monitoring”, It is widely used in the field of clinical diagnosis.
In the field of immunodiagnosis, the company focuses on the development and application of tumor markers and autoimmune clinical detection solutions. The company has developed 20 kinds of tumor marker detection products by using high-throughput flow fluorescence technology platform and chemiluminescence immunoassay technology platform. It is one of the companies with a relatively complete range of tumor marker clinical detection fields in China and even in the world; The autoimmune detection products developed by using the high-throughput flow fluorescence technology platform can realize fully automated operation, quantitative or semi quantitative detection, multiple joint detection, and fast detection, which have strong technical advantages. In addition, the company also comprehensively applies the high-throughput flow fluorescence technology platform and chemiluminescence immunoassay technology platform, and has completed or is developing detection products in the fields of autoimmunity, tumor, cardiovascular, infection, hormone, metabolism and so on.
In the field of molecular diagnosis, the company focuses on the development of clinical testing products in the fields of cervical cancer screening, personalized medication and early tumor detection. Based on the high-throughput flow fluorescence technology platform and multi-color fluorescence PCR platform, the company has developed a series of HPV detection products to provide comprehensive solutions for HPV nucleic acid detection for different customers. The human Shox2 and RASSF1A gene methylation DNA detection kit (PCR fluorescence method) developed by the company using gene methylation mutation detection technology is the first lung cancer methylation detection product in China, which can be used for auxiliary examination of alveolar lavage fluid cytology detection of suspected lung cancer population. For the clinical auxiliary diagnosis of personalized medication, the mutation detection kit of important gene loci such as EGFR, B-Raf and K-ras developed by the company can be used as the clinical auxiliary diagnosis and personalized medication guidance of tumors such as small cell lung cancer and colorectal cancer.
In addition, the “Y chromosome microdeletion detection kit” and “Toxoplasma gondii, rubella virus, cytomegalovirus and herpes simplex virus antibody detection kit” developed by the company can be used for clinical auxiliary diagnosis of eugenics. Among them, “Y chromosome microdeletion detection kit” is the first product of its kind in China to obtain the medical device registration certificate. Unique technology and rich products have won the trust and use of a wide range of customers for the company. (II) main products
The company’s products mainly cover the fields of immunity, molecule and biochemistry, involving autoimmunity, tumor, cardiovascular, infection, hormone, metabolism and other fields. By the end of the reporting period, the company had obtained a total of 301 Chinese medical device registration certificates and filing certificates. Among them, there are 186 class II and III medical device registration certificates, including 107 immune product registration certificates (including 1 instrument certificate), which are mainly tumor detection products, autoimmune detection products and cardiovascular disease detection products. They are the main products of the company, 10 molecular product registration certificates and 69 biochemical product registration certificates. At the same time, as of the end of the reporting period, 54 products of the company have passed the CE self declaration. The products meet the requirements of EU IVD 98 / 79 / EC Directive and can enter the EU market.
1. Tumor marker detection products
The company has 59 tumor markers (including calibration products and quality control products), including 20 breast cancer markers, covering 20 kinds of tumor markers, covering the most common malignant tumors in China (lung cancer, colorectal cancer, gastric cancer, female breast cancer, liver cancer, esophageal cancer, etc.). China is one of the most complete tumor markers in China. According to the confirmed data of cancer patients in China and the United States, the proportion of patients with early diagnosis in China is 10%, while that in the United States is 38%; The proportion of patients with late diagnosis in China is 50%, while that in the United States is only 24%. The early diagnosis rate of cancer is one of the important factors affecting the survival rate of cancer patients in China. The detection of tumor markers is one of the mature methods for early screening and diagnosis of tumors.
Tumor markers either do not exist in normal adult tissues, but only in embryonic tissues, or the content in tumor tissues is much higher than that in normal tissues. Their existence or quantitative change can indicate the nature of tumors, so as to understand the histogenesis, cell differentiation and cell function of tumors, so as to help the diagnosis, classification, prognosis and treatment guidance of tumors. At present, there are 28 common tumor markers. The tumor markers detected clinically have multiple sources, and most of them exist not only in malignant tumors, but also in benign tumors, embryonic tissues and even normal tissues. The same tumor or different types of tumors may have one or more abnormal tumor markers, and the same tumor marker can appear in different tumors. Therefore, when a single index is used for auxiliary diagnosis or screening of tumors, the sensitivity and specificity are not ideal. The Expert Committee on tumor markers of the branch of detection medicine of the Chinese Medical Association suggested that in order to improve the auxiliary diagnostic value of tumor markers and determine which tumor markers can be used as follow-up monitoring indicators after treatment, a number of tumor markers with complementary sensitivity and specific performance can be reasonably selected for joint detection in clinic.
The company has developed tumor marker detection kit by using two technical platforms of flow fluorescence and chemiluminescence, forming a combined application of multi index joint detection of flow fluorescence and single index detection of chemiluminescence. Among them, the tumor markers developed by high-throughput flow fluorescence technology can realize the rapid joint detection of multiple tumor markers. High throughput flow fluorescence technology uses covalent binding to crosslink the surface of different microspheres with antigens or antibodies corresponding to different detection targets, and add labeled antigens or antibodies to form a sandwich or competitive complex with the antibodies or antigens to be detected. The fluorescence signal carried on the microspheres is positively correlated with the concentration of the detected substances in the serum. Compared with other chemiluminescence, high-throughput flow fluorescence technology has the advantages of one-time detection of multiple indicators, fast detection speed, high sensitivity and accuracy, good repeatability and wide linear range. It represents the application trend of clinical immune multi indicator joint detection.
2. HPV nucleic acid detection products
HPV widely exists in nature. According to the pathogenicity or carcinogenic risk of its types, HPV can be divided into low-risk type and high-risk type. Among them, high-risk HPV infection is regarded as a necessary condition for almost all cervical cancer. Research statistics show that it generally takes several years or even 10 years from HPV infection to cervical cancer. Improving the detection of high-risk HPV and active treatment will help to eliminate the persistent infection of female reproductive tract and prevent it from evolving into cervical cancer. At the same time, it can also develop cervical cancer early, so as to reduce the incidence and mortality of cervical cancer.
For cervical cancer detection, the company has developed a series of products by using flow fluorescence technology and fluorescence quantitative PCR technology to provide comprehensive solutions for HPV nucleic acid detection for different customers. The high-risk HPV nucleic acid detection kit is one of the products with the most complete typing. It can detect 27 subtypes (17 high-risk subtypes and 10 low-risk subtypes) at one time, and accurately distinguish single type of persistent infection, multiple infection and different types of recurrent infection; The “5 + 9” HPV typing kit is used to detect the first five infection subtypes and the other nine subtypes that cause 90% of cervical cancer in China, especially for early screening of cervical cancer in Chinese women; “2 + 12” HPV typing test kit detects 2 high-risk subtypes and 12 other subtypes recommended by who. It is one of the most economical HPV testing products.
3. Autoimmune disease detection products
Antibodies are generally produced by the immune system after foreign proteins or other substances (such as pathogenic bacteria) enter the body, which are used for immune response to eliminate foreign harmful substances. Under normal circumstances, the immune system will not produce antibodies against itself, but some disease antigens have similar molecular structures with their own components, or some infectious factors denature and modify their own antigens, resulting in the wrong response of the immune system to produce autoantibodies, which then attack their own cells, tissues and organs, cause inflammatory reaction and cause damage to the body. Autoantibodies are one of the basic characteristics of autoimmune diseases. They are of great significance in disease judgment, prognosis evaluation and risk prediction. Because one kind of autoantibody corresponds to many kinds of autoimmune diseases, or one kind of autoimmune disease has many kinds of autoantibodies, autoimmune diseases are relatively complex, so it is necessary to carry out joint detection of autoantibodies. The company has developed a series of autoimmune detection products by using flow fluorescence technology to realize multiple detection of autoimmune antibodies. The operation is fully automatic, fast and efficient, quantitative (or semi quantitative), random sampling and other characteristics, including autoantibody spectrum, vasculitis, autoimmune liver disease antibody spectrum, etc. among them, 16 autoantibody spectrum detection kits (flow fluorescence luminescence method) can detect 16 autoantibodies at a time, It is used to assist in the diagnosis of common autoimmune diseases, such as systemic lupus erythematosus, Sjogren’s syndrome, systemic sclerosis, mixed connective tissue disease, polymyositis, primary biliary cirrhosis, etc. the detection speed is much higher than that of similar products in China. By the end of the reporting period, the company had 8 class II medical device registration certificates for autoimmune testing, involving more than 30 related markers.
4. Methylation mutation detection products
DNA methylation is a kind of phenotypic modification, which is closely related to the occurrence of cancer. It is found in almost all cancers and occurs in the pre cancer or early stage of cancer. Therefore, it is expected to become an ideal detection marker for early cancer diagnosis.
Short homeobox gene (Shox2) and RAS related family 1A (RASSF1A) are common markers of DNA methylation in lung cancer. The company has developed human Shox2 and RA for this purpose
