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
Annual report for 2021
Important tips
1、 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 without false records, misleading statements or major omissions, and bear individual and joint legal liabilities. 2、 Unprofitable and unprofitable when the company is listed □ yes √ no III. tips on major risks
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. 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、 Xiao Weihong, the person in charge of the company, sun Yongzhi, the person in charge of accounting, and Zheng Lirong, the person in charge of accounting organization (Accounting Supervisor), declare that they guarantee the authenticity, accuracy and integrity of the financial report in the annual report. 7、 The profit distribution plan or the plan of converting accumulation 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 IX. risk statement of forward-looking statements √ applicable □ not applicable
The company’s future plans, development strategies and other forward-looking statements involved in this report do not constitute the company’s substantive commitment to investors. Investors are reminded to pay attention to investment risks. 10、 Whether there is any non operational occupation of funds by the controlling shareholders and their related parties no Xi. Whether there is any external guarantee in violation of the specified decision-making procedures no XII. Whether more than half of the directors cannot guarantee the authenticity, accuracy and completeness of the annual report disclosed by the company no XIII. Others □ applicable √ not applicable
catalogue
Section 1 interpretation Section 2 company profile and main financial indicators Section III Management Discussion and Analysis Section IV corporate governance Section V environment, social responsibility and other corporate governance 84 section VI important matters Section VII changes in shares and shareholders Section VIII preferred shares Section IX. corporate bonds 141 section x financial report one hundred and forty-two
Financial statements containing the list of documents signed and sealed by the legal representative of the company, the person in charge of accounting and the person in charge of accounting institutions for future reference.
The original of the audit report with the seal of the accounting firm and the signature and seal of the certified public accountant.
Originals of all company documents and announcements publicly disclosed during the reporting period.
Section I interpretation
1、 Interpretation in this report, unless the context otherwise requires, the following words have the following meanings: Interpretation of common words
Company / the company refers to Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) Pharmaceutical (Shanghai) Co., Ltd
/ Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336)
Sansheng pharmaceutical refers to 3sbio Inc., a company established under the laws of the Cayman Islands and listed on the stock exchange of Hong Kong, with the stock code of 1530 HK
Fujian pharmaceutical refers to full gain pharmaceutical limited, a limited company established under the laws of Hong Kong
Lansheng Guojian / Xing refers to Shanghai Lansheng Guojian Pharmaceutical Co., Ltd. (later renamed “Shanghai Xingsheng Pharmaceutical Co., Ltd.”)
Shenyang Sansheng refers to Shenyang Sansheng Pharmaceutical Co., Ltd
Shanghai Shengguo refers to Shanghai Shengguo Pharmaceutical Development Co., Ltd
Shanghai Haoxi refers to Shanghai Haoxi enterprise management consulting center (limited partnership)
Pudong Lingyu refers to Shanghai Pudong Lingyu Investment Development Center (limited partnership)
Pudong Tianyu refers to Shanghai Pudong Tianyu Investment Development Center (limited partnership)
Grand path means grand path Holdings Limited, a limited company incorporated under the laws of Hong Kong
Shanghai hongentropy refers to Shanghai hongentropy Investment Consulting Co., Ltd
Hong Kong Sansheng means Hong Kong Sansheng medical limited, a limited company established under the laws of Hong Kong
Hong Kong Daka refers to achieve well international (Hong Kong) Limited, a limited company established under the laws of Hong Kong
Antibody center refers to Shanghai National Engineering Research Center for antibody drugs Co., Ltd
Zhongjian antibody refers to Zhongjian antibody Co., Ltd
Suzhou Guojian refers to Sunshine Guojian Pharmaceutical(Shanghai) Co.Ltd(688336) Pharmaceutical (Suzhou) Co., Ltd
Dansheng pharmaceutical refers to Dansheng Pharmaceutical Technology (Shanghai) Co., Ltd
Numab refers to numab therapeutics, Ag
Campanine refers to Shanghai campanine Medical Technology Co., Ltd
Beijing Yingtong refers to Beijing Yingtong Technology Development Co., Ltd
Suzhou Qide Jianguang Technology Co., Ltd
Verseau means Verseau therapeutics, Inc
Antibody refers to the immunoglobulin produced by plasma cells differentiated from B lymphocytes under the stimulation of antigen, which can specifically bind with the corresponding antigen
Monoclonal antibody / refers to a highly homogeneous antibody produced by a single B-cell clone that only targets a specific epitope
Bispecific antibody refers to having two specific antigen binding sites, which can interact with target cells and functional bodies / double antibody cells (generally T cells) at the same time, so as to enhance the killing effect on target cells
Biological analogues refer to therapeutic biological products that are similar to the approved registered original drugs (reference drugs) in terms of quality, safety and effectiveness.
Development of candidate drugs for biological analogues
In principle, the amino acid sequence should be the same as that of the original drug (reference drug). Biological analogues are not generally considered as generic drugs of their original drugs, because the two products are similar, but may not be exactly the same. Strict regulatory requirements need to be met in terms of pharmacokinetics, pharmacodynamics, safety and effectiveness between biological similar drugs and reference drugs
Autoimmunity refers to the disease caused by the abnormal immune response of the human body to the substances and tissues normally existing in the body
Rheumatoid arthritis refers to rheumatoid arthritis or rheumatoid arthritis (RA). It is a chronic systemic inflammatory disease with unknown etiology. Its main clinical manifestations are chronic arthritis, symmetry, multiple synovial arthritis and extraarticular lesions. It belongs to autoimmune disease
Ankylosing spondylitis (as) is a chronic progressive inflammatory disease, which mainly invades the sacroiliac joint, spinal process, paraspinal soft tissue and peripheral joints. It can be accompanied by extraarticular manifestations. In severe cases, spinal deformity and joint ankylosis can occur. It belongs to seronegative spondyloarthropathy, which is an arthritis related to spondylitis
Psoriasis refers to psoriasis, which is a common chronic recurrent inflammatory skin disease. The typical skin lesions are scaly erythema
Target refers to the target molecule targeted by drug therapy, which usually plays an important role in the pathological process of the disease. Drugs produce clinical efficacy by inhibiting or activating the biological activity of the target molecule
TNF- α Tumor necrosis factor- α， Refers to tumor necrosis factor- α， Macrophages are one of the major cytokines in the acute phase of inflammation
HER2 refers to Human Epidermal Growth Factor Receptor-2, which refers to -2 of human epidermal growth factor receptor. It is an important prognostic factor for breast cancer and gastric cancer.
CD20 refers to the expression on the surface of B cells at all stages of development and differentiation except plasma cells (B cells secreting immunoglobulin). It directly acts on B cells by regulating transmembrane calcium flow and plays an important regulatory role in B cell proliferation and differentiation
EGFR refers to epidermal growth factor receptor, which is often expressed on epidermal cells
PD-1 refers to programmed cell death protein 1
VEGF refers to vascular endothelial growth factor, a highly specific vascular endothelial growth factor, which can promote the increase of vascular permeability, the degeneration of extracellular matrix, the migration, proliferation and angiogenesis of vascular endothelial cells
IL-17 refers to interleukin-17 and interleukin-17, which is secreted by helper T cells 17
