Company code: Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513) company abbreviation: Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513) Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513)
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 described in detail various risks and countermeasures that the company may face in the process of production and operation in this report. Please refer to "IV. risk factors" in Section III "management discussion and analysis". Investors are kindly requested to pay attention and pay 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 attended 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
After deliberation at the second meeting of the third board of directors of the company, the profit distribution plan of the company for 2021 is proposed as follows: Taking the total share capital of the company as 120090000 shares at the end of the reporting period as the base, distribute cash dividends of RMB 7.8 (tax included) to all shareholders for every 10 shares, and distribute cash dividends of RMB 93670200 (tax included) in total; The company does not give bonus shares or convert capital reserve into share capital.
The profit distribution plan can only be implemented after being deliberated and approved by the company's 2021 annual general meeting of shareholders. 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 Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513) Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513) not applicable
Scientific innovation board
Profile of company 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: Wang yiou, Li Shuyun
Office address: Ankang Road, Shuangliu District, Chengdu
Tel: 0288610666802886106668
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
Chengdu Easton Bio Pharmaceuticals Co.Ltd(688513) is a high-tech enterprise driven by R & D and innovation and integrating the whole industrial chain of R & D, production and sales of chemical raw materials, high-end chemicals and biological drugs. The company adheres to the mission of "taking patients as the center and bathing the sunshine for human health". Relying on continuous technological innovation, China has gradually established a leading and international standard R & D technology and industrialization platform, and has concentrated on the field of narcotic analgesia. It also takes account of the rapid development of the large market fields such as diabetes, cardiovascular, anti-cancer and other fields, and speeds up the research and industrialization of small molecule entities and biological drugs. Quickly meet unmet clinical needs outside China.
2. Main products or services
(1) High end chemicals
As of the disclosure date of this report, the company has successfully realized the industrialization of 27 high-end chemicals, including 4 China's first imitation products and 17 products that have passed the consistency evaluation (of which 5 are the first to pass). The main chemicals of the company are as follows:
Indications or functional indications of main products in the field
Reversal of opioid action by nalmefene hydrochloride injection and its first listing
Treatment of similar substance overdose
Anesthetized adults and children 6 months and older
Tongibuprofen injection department is the first to treat mild to moderate pain. It is the first to imitate the market and reduce fever through consistency evaluation
National bid winning period for acute arthritis and chronic arthritis tablets
Symptoms and signs during
Bisoprolol fumarate tablets were the first to pass the consistency evaluation for hypertension and coronary heart disease, and the first in the order of heart and brain blood won the bid for the centralized purchase of national drugs
Guanxin oral direct anticoagulant drugs, which comply with dabigatran ester capsule, have good anticoagulant drugs, and are deemed to have passed the consistency evaluation, medium
Indications or functional indications of main products in the field
National drug centralized procurement
Ibandronate injection has rich specifications for osteolytic bone metastasis of malignant tumor
Bone pain caused by bone pain, hypercalcemia
Combined with chemotherapy, radiotherapy and combined stress
Anti tumor is used for leukemia and multiple bone marrow. The self-produced API that has passed the registration of MF ubenimex capsule tumor and myelodysplastic syndrome in Japan is used; Oral preparation compliance and hematopoietic stem cell transplantation are better; Rich specifications
And other solid tumor patients
Children's drug caffeine citrate injection is the first imitation of primary respiration in premature newborns
suspend
Compound Glycyrrhizin for digestion and injection has rich specifications for chronic liver disease
According to the database of public hospitals in key provinces and cities in China, in q1-q3 of 2021, the market share of three products of the company's nine main products: nalmefene hydrochloride injection, ibuprofen injection and ibandronate sodium injection ranked first, and the market share of four products: bisoprolol fumarate tablets, etocoxib tablets, caffeine citrate injection and ubenimex capsules ranked second, The market share of Compound Glycyrrhizin for injection ranked third and dabigatran ester capsule ranked fourth, reflecting the strong market competitiveness of the company's products.
(2) Small molecule innovative drugs and biological drugs
There are more than 10 innovative drugs in 1 categories. 3 of them have been tested in clinical trials. They are: yogurt tablets, the 1 new drugs that are developed by the company independently, and the first oral long acting hypoglycemic drugs used in type 2 diabetes in China. This product has significant hypoglycemic effect and has unique pharmacokinetics characteristics of intestinal excretion. Patients with renal impairment need not adjust dosage, improve compliance of diabetic nephropathy patients and adapt to wider population. As of the disclosure date of this report, the company has completed the phase II clinical trial of eugliptin tablets and was approved to carry out the phase III clinical trial. No new oral hypoglycemic drugs are available in China once a week.
Cx3002 tablet, a new chemical class 1 drug jointly developed by the company, is a new oral factor Xa inhibitor, which is mainly intended to prevent the formation of acute deep venous thrombosis. Compared with the same target drug, cx3002 has a clear mechanism of action and outstanding efficacy; The apparent distribution volume is lower; Unique intestinal excretion; The drug time curve is stable; "Low peak valley ratio" and wide safety range. By the end of the reporting period, the phase I clinical trial of the project had been completed.
Ep-9001a injection, the first biological class 1 new drug independently developed by the company, is a humanized monoclonal antibody drug with a new action mechanism, and the target is human nerve growth factor (NGF). Its mechanism of action is to selectively target and inhibit NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain. It has a new mechanism of action different from opioids, non steroidal anti-inflammatory drugs and other analgesics. It can effectively relieve pain and avoid addiction. It has the characteristics of strong targeting and high specificity, and has a broad market prospect. As of the disclosure date of this report, ep-9001a injection has completed ind application and is approved to carry out phase I clinical trial.
In addition, the company has a series of candidate drugs ep-0093i + ep0093a and ep-0108o + ep-0108a of new molecular entities, and many other projects are undergoing preclinical and early exploratory research.
(3) API
The company has established the advantages of the integrated industrial chain of APIs and preparations, continuously extended and expanded the industrial chain, and actively participated in international competition. By the end of the reporting period, the company has successfully realized the industrialization of 18 high-end chemical API products, the independent supply of several major chemicals, the export of 10 APIs to the mainstream international market, and the successful expansion of API CMO / cdmo business. The company's main chemical API products are clomivir hydrochloride, bisoprolol fumarate and nalmefene hydrochloride. Clomivir hydrochloride provides CMO / cdmo services for clomivir hydrochloride capsule, a new chemical class 1 drug of Beijing Caine. （2） Main business model 1. R & D model
Guided by the clinical demand, based on the in-depth study of the disease mechanism, the company focuses on key areas, plans the overall layout of biological drugs, small molecule innovative drugs and high-end generic drug product groups, creates Yuandong characteristic product pipeline and forms a differentiated competitive advantage. The company focuses on independent research and development, while constantly strengthening the BD function, actively layout innovative drugs through external introduction, cooperative development and other ways, accelerate the breakthrough of innovative drug research and development, and promote the international transfer or cooperative development of self-developed varieties. In the field of biological drugs, the company focuses on antibody technology and biological coupling technology, focuses on potential targets in the fields of anti-tumor, anesthesia, analgesia and immune diseases, seeks differentiated advantages, and speeds up the layout of product pipelines through self-research, introduction and cooperation. By the end of the reporting period, the company had a number of class 1 biological drugs under research. Among them, the self-developed ep-9001a monoclonal antibody injection in the field of anesthesia and analgesia has completed the ind application and been approved to carry out phase I clinical trials. At the same time, several class 1 innovative biological drugs are at different stages of early discovery.
In the field of small molecule innovative drugs, the company focuses on the fields of anesthesia, analgesia, cardiovascular, anti-tumor and diabetes, and continuously builds and improves the platform of innovative drug research and development, and vigorously enriches the core product pipeline, which is mainly based on new molecular entities and new technologies (PROTAC, etc.). By the end of the reporting period, the company has two class 1 small molecule innovative drugs, eugliptin tablets and cx3002, which are in clinical trials. Class 1 new drug ep-0093i + ep-0093a in the field of anesthesia and analgesia and class 1 new drug ep-0108o + ep-0108a in the field of antitumor are in the stage of preclinical research.
In terms of high-end generic drugs, the company focuses on key areas, relies on the established special drug technology, slow and controlled release technology and other platforms, develops special drugs, slow and controlled release, long-term and high activity drugs with technical barriers and policy thresholds, vigorously promotes the first imitation and rush imitation varieties, creates 1 + X pipeline, and wins with high iterative ability and differentiation.
In terms of internationalization, the company has laid out the international pipeline under research with the idea of "shortage of foreign market, long patent period, long medication cycle and first imitation PIV application". At present, internationalization focuses on in-depth development in the field of characteristic antidotes. Ep-0084a & I has been granted CGT qualification by FDA in April 2021, which can accelerate the review.
2. Production mode
The production mode of the company is mainly independent production. Under the independent production mode, the company formulates the production plan based on sales, reasonably formulates the production plan of each workshop in combination with the production capacity of each product, and coordinates and supervises the completion of the production plan. In the production process, the company supervises and manages in strict accordance with GMP and the latest laws and regulations to ensure product quality and product safety and effectiveness.
Due to limited production capacity and other reasons, a small number of chemicals of the company cooperate with Chengdu Tongde Pharmaceutical Co., Ltd., Chengdu Tiantaishan Pharmaceutical Co., Ltd. and other companies to adopt entrusted production and cooperative production
