Company code: Shanghai Rightongene Biotechnology Co.Ltd(688217) company abbreviation: Shanghai Rightongene Biotechnology Co.Ltd(688217) Shanghai Rightongene Biotechnology Co.Ltd(688217)
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 risks: the company has described the possible risks in this report. Please refer to "IV. risk factors" in "section III Management Discussion and analysis" to draw investors' attention to 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 attend the board meeting. 5 Zhonghui 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
Fully considering that the company is currently in a period of rapid development, R & D projects, fixed asset investment and marketing network are expanding, and the capital demand is large, in order to better safeguard the long-term interests of all shareholders and ensure the sustainable development and capital demand of the company, the company plans not to distribute cash dividends, bonus shares, transfer capital reserve into share capital and other forms of distribution in 2021, and the remaining undistributed profits will be accumulated to the next year. The above profit distribution plan has been deliberated and approved at the fourth meeting of the second board of directors and the fourth meeting of the second board of supervisors, and needs to be submitted to the 2021 annual general meeting of shareholders of the company for deliberation. 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 Shanghai Rightongene Biotechnology Co.Ltd(688217) Shanghai Rightongene Biotechnology Co.Ltd(688217) 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: Li yanfan Ming
Office address: Building 3, No. 6055, Jinhai Road, Fengxian District, Shanghai Jinhai Road, Fengxian District, Shanghai
Building 3, No. 6055
Tel: 02133282 Spring Airlines Co.Ltd(601021) 33282601
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 conditions of the company
Shanghai Rightongene Biotechnology Co.Ltd(688217) . Since its establishment, the company has been actively committed to the national strategy of "precision medicine", always with the mission of "protecting more people from cancer" and the vision of "becoming the most trusted gene company by users". The company will continue to adhere to the core values of "real person, sincerity and true ability" and the business philosophy of "cognition is greater than facts, leading comes from innovation", and is determined to become the best in vitro diagnosis enterprise in the field of accurate detection of tumors.
The company's main business is the R & D, production, sales, scientific research and testing services of in vitro diagnostic products (including testing instruments and reagents), mainly providing accurate detection of genes and antigens for patients with blood diseases (leukemia, lymphoma), solid tumors (lung cancer, colorectal cancer, melanoma, etc.) and infectious diseases (hepatitis B, rubella, herpes simplex, etc.), and providing services for disease diagnosis, risk assessment, disease typing To provide basis for the formulation of individualized treatment schemes such as targeted drug selection and efficacy monitoring. At the same time, the company is also vigorously expanding antigen detection reagent products for immunodiagnosis. The products are mainly used in the fields of leukemia screening, tracking and stock patient reexamination, which has become a powerful supplement to the company's products in the field of leukemia.
2. Products and services of the company
The company mainly provides customers with its own brand of molecular diagnostic reagents, scientific research services, testing services and molecular testing equipment. At present, the main products are leukemia, lymphoma, solid tumor and infectious disease related gene molecular diagnostic kits. The main services include providing third-party medical testing services for all kinds of medical institutions, pharmaceutical enterprises and individual patients, as well as research hospitals, pharmaceutical enterprises, scientific research institutions Third party testing institutions and other enterprises and institutions provide scientific research services for gene testing. As of December 31, 2021, the company has 103 medical device products approved by the State Food and Drug Administration or filed with the competent drug administration, including 29 registered products of class III medical devices.
(1) In vitro diagnostic kit
As of December 31, 2021, Shanghai Rightongene Biotechnology Co.Ltd(688217) has 97 medical device diagnostic kit products approved by the State Food and Drug Administration or filed by the drug regulatory authority, including 29 class III medical device registration certificate products and 68 class I medical device filing products (including 30 antigen detection reagent products for immune diagnosis), covering blood diseases (leukemia, lymphoma) In the fields of solid tumors (lung cancer, colon cancer, melanoma) and infectious diseases, a number of molecular diagnostic kits are the exclusive or first products in China and have a leading position in the market. The details of the three main types of medical devices are as follows:
Category product name market position legend
Leukemia related fusion is the first molecular diagnosis for leukemia certified by the State Food and Drug Administration in China
Leukemia gene detection kit products;
Approved on: September 2012
Lymphoma immunoglobulin gene, which is exclusively certified by the State Food and Drug Administration in China, is used for molecular diagnosis of lymphoma
Rearrange test kit products; Time of approval: September 2020
The human EGFR gene mutation was the first in China to be approved by the State Food and drug administration by fluorescence PCR and first-generation sequencing
Variable detection kit is a molecular diagnostic product certified by the Bureau for detecting lung cancer and colorectal cancer;
Approved on: July 2012
Human K-ras and B-Raf are the first in China to use "one tube and multiple tests" to obtain the certification of the State Food and drug administration
Solid tumor gene mutation test is a molecular diagnostic product for cancer, colorectal cancer or melanoma;
Approval time of agent box: July 2012
UGT1A1 genotype is the first in China to be certified by the State Food and Drug Administration for the detection of clinically advanced colorectal cancer
Detection kit: molecular diagnostic products related to cancer and lung cancer;
Approved on: September 2012
Human rubella virus nucleic acid is the first one in China certified by the State Food and drug administration to detect human serum or plasma stroke
Molecular diagnostic products for detecting nucleic acid of measles virus;
Approved on: January 2014
Ureaplasma parvum nucleic acid is an exclusive test for detecting Ureaplasma parvum in human body certified by the State Food and Drug Administration in China
Molecular diagnostic products for detecting nucleic acids of the kit;
Approved on: August 2011
Herpes simplex virus, the first infectious disease in China to be certified by the State Food and drug administration, is type 1 and type 2
Type 1 + 2 nucleic acid molecular diagnostic product for detecting nucleic acid of herpes simplex virus;
Approval time of Kit: December 2012
Hepatitis B virus was the first virus in China to be certified by the State Food and drug administration by fluorescence real-time quantification
Detection of hepatitis B virus pre-C region 1896 by PCR
Diagnostic products due to mutation detection reagents;
Time of approval: January 2014
(2) Scientific research service
The company uses digital PCR, second-generation sequencing, fast fish, liquid chip, full-spectrum flow and other advanced technical means to provide research hospitals, pharmaceutical enterprises, scientific research institutions and third-party testing institutions with services applied to basic research, disease typing, drug adaptability, target gene testing and other aspects, covering the fields of blood diseases (leukemia and lymphoma), solid tumors and infectious diseases.
(3) Medical testing service
Steed biology, the holding subsidiary of the company, has independent third-party medical laboratories in Wuhan, Shanghai and Beijing, engaged in clinical testing or pathological diagnosis and services. The third-party medical laboratory establishes business cooperation with various medical institutions at all levels to collect and test the samples collected in cooperation; After the test, the test results will be returned to the medical institution for clinical service. In addition, siteide biological has also undertaken personal medical testing business, insurance company physical examination business, etc. (4) In vitro diagnostic instrument
As of December 31, 2021, Changchun Jite has obtained 7 medical device diagnostic kit products filed by the competent department of drug supervision and administration, including 2 products with class II medical device registration certificate and 5 products with class I medical device registration certificate. The main products are as follows:
Category product name market position legend
Automatic sample processing system
(class I medical device certificate) China was the first to obtain the medical device registration certificate
Book of digital PCR platform products.
Approval time of digital PCR platform:
The first generation of automatic biochip reader, June 2019;
(class II medical device certificate) second generation products June 2021
Human body fluid free DNA nucleic acid extraction device
Preparation, for accurate tumor detection, sensitivity
Automatic nucleic acid extraction and purification instrument, high, fully closed, 8-Channel, fully automatic,
(class I medical device certificate) copy number and low mutation point.
Approved on:
Other equipment generation products may 2019;
Second generation products August 2020
Cell photography imaging technology is used for fine
Cell sorter cell count, cell survival rate analysis, cell
(class I medical device certificate) calculation of concentration and agglomeration rate. Fully automatic operation
To prevent cross contamination.
Time of approval: June 2019
2. Advantages of the company's products and services
(1) Advantages of the company's blood disease products
○ 1 leukemia products
The company's three fusion gene kit products obtained class III medical device certificates in 2012, which was the only one in China for six years
