Company code: Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) company abbreviation: Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) Pharmaceutical (Shanghai) Co., Ltd
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 go to the website of Shanghai Stock Exchange (www.sse. Com. CN.) The website carefully reads the full text of the annual report. 2 major risk tips
The company has elaborated the risk factors of the company’s core competitiveness risk, operation risk and industry risk in this report. Please refer to the “risk factors” in Section III “management discussion and analysis” of this report. Investors are reminded to pay special attention to the following risks:
1. Risk of sharp decline in performance or loss in 2022
In 2021, recombinant human tumor necrosis factor receptor antibody fusion protein was included in the centralized procurement list of 153 drug groups including diclofenac of Guangdong alliance. In March 2022, the company’s core product ISAP won the bid with the price of 127 yuan / piece as the proposed alternative product, with a price decrease of 60%, which will have a certain impact on the growth of the company’s operating revenue. At the same time, in order to cope with the increasingly fierce market competition environment, the company does not rule out the possibility of further reduction of product prices in the future.
In view of the continuous deepening of the company’s R & D project process and the forward-looking layout of the future antibody drug R & D field, the early investment of R & D projects increases, and the R & D investment of research projects increases with the needs of their R & D stage. It is expected that the company will continue to generate a large amount of R & D expenses in the future. If the R & D expenses are greater than the profits generated by commercial products, the company will suffer losses.
2. The R & D of innovative drugs faces uncertainty and greater market competition risks
The R & D of innovative drugs has the characteristics of long R & D cycle, large investment, high risk and low success rate. From the project establishment to the approval and listing of new drugs, there are many complex links, such as preclinical research, clinical trials, registration and listing of new drugs and after-sales supervision. Each link may face the risk of failure. In addition, considering the risk of drug research and development and the uncertainty of market competition faced by the future product listing, if the company cannot effectively make use of its R & D technology experience, large-scale production advantages or terminal sales coverage, the products under research may not be approved for listing first among the products with the same target, and the related products will face a more competitive market environment, Then it will have an adverse impact on the growth of the company’s operating performance and sustainable profitability.
In the future, the company needs to continue the research and development of innovative drugs to ensure that the company continues to introduce new products to the clinic and then to the market. However, the company cannot guarantee that it can continuously find indications with commercial value. The potential products screened by the company may not have further development potential due to insufficient effectiveness and other reasons. If the company cannot continuously develop new products with commercial potential, it may have an adverse impact on the company’s business. 3 the board of directors, the board of supervisors and the directors, supervisors and senior managers of the company guarantee that the contents of the annual report are true, accurate and complete, 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 Ernst & Young Huaming 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: no cash dividend, no bonus shares, and no capital reserve converted into share capital. The above profit distribution plan has been deliberated and approved at the 7th Meeting of the 4th board of directors of the company and needs to be deliberated and approved by the general meeting of shareholders of the company. 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
RMB common stock (a) Shanghai Stock Exchange Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) not applicable
(1) Kechuang 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: Liu Yanli, Zhang Fengzhan
Office address: No. 399, libing Road, China (Shanghai) pilot Free Trade Zone
Tel: 02150791399
E-mail ir@3s -guojian. com. ir@3s -guojian. com.
2. Introduction to the company’s main business in the reporting period (I) main business, main products or services
（1） Main business, main products or services
1. Main business
Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) is the first batch of innovative biomedical enterprises focusing on antibody drugs in China. At the same time, it has the ability of independent research and development, industrialization and commercialization. With innovative therapeutic antibody drugs as the main research and development direction, the company provides high-quality, safe and effective clinical solutions for the treatment of major diseases such as autoimmune diseases and tumors. Adhering to the concept of “cherishing life, paying attention to survival and creating life”, the company is committed to becoming an innovative therapeutic antibody drug company benefiting China and facing the world, and realizing the corporate vision of “making innovative antibody drugs within reach”. As an innovative biomedical enterprise focusing on antibody drugs, the company has a National Engineering Research Center for antibody drugs, and its core technology covers the whole process of antibody drug R & D. The company has prospectively constructed multiple technical platforms for innovative antibody drugs, and has the systematic innovation ability from drug discovery, preclinical research, pilot process development, quality research, clinical research to industrialization.
2. Main products
(1) Listed products:
ISEP (recombinant human type II tumor necrosis factor receptor antibody fusion protein)
In 2021, driven by multiple factors such as price for volume, channel sinking and patient-centered promotion mode, the sales revenue of ISEP increased significantly.
In 2021, the sales volume of ISEP (China) was 2884400 pieces (equivalent to 25mg), with a year-on-year increase of 89.81%. ISEP’s sales revenue in China reached 789 million yuan, a year-on-year increase of 28.18%.
ISEP has been listed in China for 16 years. Compared with other similar products, the drug efficacy and safety of ISEP have been more widely verified and recognized in the Chinese market, and has a strong brand effect in clinical application. In addition to product features, the company has a professional marketing team and a complete sales system. Through years of academic promotion and sales experience accumulation and precipitation of ISEP, the company has achieved good results in the coverage of terminal sales in China.
Ceptin (initumab for injection)
Septin was officially approved by the State Drug Administration (nmpa) in June 2020. At the end of December 2020, septin passed the medical insurance negotiation and was included in the national medical insurance catalogue for the first time. Since its launch, it has been included in a number of guidelines and expert consensus: according to the guidelines for the diagnosis and treatment of breast cancer in the China Society of Clinical Oncology (COSO), Sai Puting is the basic drug for the treatment of advanced breast cancer patients in the whole course of anti HER2 therapy. According to the China consensus guide for breast cancer consensus 2020 (CABC3) published by the China Women’s Medical Association breast disease research center, Sai Puting has become one of the best treatment options for advanced breast cancer. Enantizumab has been incorporated into the guidelines for clinical application of new anticancer drugs formulated by the national health and Health Council of China (2021 Edition) and China Cancer Society’s guidelines and guidelines for breast cancer diagnosis and treatment (2021 Edition) published by China Cancer Society.
After siptin started medical insurance reimbursement on March 1, 2021, it quickly promoted hospital access and completed the layout of the core market. In 2021, the number of grade hospitals covered by septin exceeded 500. In 2021, the sales revenue of ceptin increased by 356.03% year-on-year compared with the same period last year.
Genipipil (recombinant anti-CD25 humanized monoclonal antibody injection)
The company’s self-developed jiannipi was listed in October 2019. The product can be used to prevent acute rejection caused by renal transplantation, and can be combined with conventional immunosuppressive regimen. It can significantly improve the survival rate of transplanted organs and improve the quality of life of patients. Gennipil is the only humanized anti-CD25 monoclonal antibody approved to be listed in China. Among the listed products in China, the main competitive product is Novartis Shulai ®。 In terms of product characteristics, as a humanized anti-CD25 monoclonal antibody, ginipex has lower immunogenicity and higher safety.
With the collaborative support of the marketing department and other departments, the company has gradually increased the academic promotion of jiannipi in clinical application, met the clinical medication needs of relevant patients, and promoted the sales coverage of hospitals all over the country. In 2021, the revenue of jiannipi increased by 106.31% year-on-year.
(2) Products under development
In 2021, the company received 9 clinical approvals, namely: 612, 613 (PFS, sJIA), 705 (China and the United States), 706 (China and the United States), 707 (the United States, which has been transferred to Dansheng medicine) and 609 Xinfu; Since 2022, four clinical approvals have been obtained, namely: 302H Xinfu, 613 (Ag), 707 (China, transferred to Dansheng medicine) and 617. At the same time, since 2021, as of the disclosure date of this report, the company has also made a number of significant clinical progress (see below for details).
As of the disclosure date of this report, the company’s R & D pipeline has 16 products, including 18 clinical R & D projects in China, including 2 preclinical R & D projects: 621 (IL-33) chronic obstructive pulmonary disease and 620 (vsig-4) solid tumor); Two projects were declared in ind: 608 (IL-17A) for axial spondyloarthritis and 611 (IL-4R) α) Chronic sinusitis with nasal polyps); Six projects entered clinical phase I: 610 (IL-5) severe eosinophilic asthma and 611 (IL-4R α) Adult moderate severe atopic dermatitis, 612 (HER2) breast cancer, 705 (double resistant) solid tumors, 706 (double resistant) solid tumors, and 617 (PSGL-1) solid tumors. Five projects entered clinical phase II: 608 (IL-17A) moderate and severe plaque psoriasis, 613 (IL-1 β） Acute gouty arthritis, 602 (EGFR) metastatic colorectal cancer, 609A (PD-1) solid tumor, 302H (HER2) breast cancer new adjuvant); Two projects entered clinical phase III: 304r (CD20), 601a (VEGF); One project has applied for NDA: 301s (ISEP water needle).
The company is in the clinical stage. The main indications and R & D Progress of product development are as follows:
Treatment field serial number code target project name indication preclinical ind clinical phase I clinical phase II clinical phase III NDA
1 301s TNF- α Recombinant human type II tumor necrosis factor receptor antibody fusion protein rheumatoid arthritis, mandatory spondylitis and psoriasis
Recombinant il-17o-2 monoclonal antibody against moderate to severe psoriasis
Axial spondyloarthritis (AX SPA)
Autoimmune 3610 IL-5 recombinant anti-IL-5 humanized monoclonal antibody severe eosinophilic asthma
Disease adult moderate to severe atopic dermatitis
4 611 IL-4R recombinant anti-il-4r α Humanized monoclonal antibody chronic sinusitis with nasal polyps
5 613 IL-1 β Recombinant anti-il-1 β Humanized monoclonal antibody acute gouty arthritis
6 621 IL-33 recombinant anti-il-33 humanized monoclonal antibody chronic obstructive pulmonary disease
7 304r CD20 recombinant human mouse chimeric anti-CD20 monoclonal antibody non Hodge
