Betta Pharmaceuticals Co.Ltd(300558)
Annual report for 2021
April 2022
catalogue
Section I important tips, contents and definitions Section 2 company profile and main financial indicators 4 section III Management Discussion and Analysis Section IV corporate governance 35 Section V environmental and social responsibility 59 section VI important matters Section VII changes in shares and shareholders 78 Section VIII preferred shares 86 section IX relevant information of bonds 87 section x financial reporting eighty-eight
Section I important tips, contents and definitions
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.
Ding lieming, the person in charge of the company, fan Jianxun, the person in charge of accounting, and Wang Tieqi, the person in charge of the accounting organization (Accounting Supervisor), declare that they guarantee the authenticity, accuracy and completeness of the financial report in this annual report.
All directors have attended the meeting of the board of directors to consider this report.
The forward-looking descriptions such as future plans and development strategies involved in this report do not constitute the company’s substantive commitment to investors. Investors and relevant persons should maintain sufficient risk awareness and understand the differences between plans, forecasts and commitments.
There may be market competition, new drug research and development and other risks in the production and operation of the company. The specific contents of relevant risk factors are described in the chapter “Xi. Prospects for the future development of the company” in Section III “management discussion and analysis” of this report. Please pay attention to the investment risks.
The profit distribution plan approved by the board of directors is: take 415388667 shares as the base, distribute cash dividend of 2.50 yuan (including tax) to all shareholders for every 10 shares, give bonus shares of 0 shares (including tax), and transfer capital reserve to all shareholders for every 10 shares.
interpretation
Explanatory item refers to the explanatory content
Betta Pharmaceuticals Co.Ltd(300558) , parent company, the company and the company refer to Betta Pharmaceuticals Co.Ltd(300558)
The reporting period refers to the period from January 1, 2021 to December 31, 2021
Beijing R & D center refers to Betta Pharmaceuticals Co.Ltd(300558) Beijing new drug R & D center, which is a branch of the company
Hangzhou R & D center refers to Betta Pharmaceuticals Co.Ltd(300558) Hangzhou new drug research and development branch, which is a branch of the company
Nmpa means the State Drug Administration
CDE refers to the drug evaluation center of the State Drug Administration
Health commission refers to the National Health Commission of the people’s Republic of China
Ministry of finance means the Ministry of finance of the people’s Republic of China
CSRC refers to the China Securities Regulatory Commission
GMP refers to the good manufacturing practice for drugs
Any systematic study of drugs in human body to confirm or reveal the effects, adverse reactions and / or absorption, distribution, metabolism and excretion of test drugs, with the purpose of determining the efficacy and safety of test clinical trials, clinical studies and clinical indications. To apply for the registration of new drugs, clinical trials (including bioequivalence trials) shall be conducted. The clinical trials are divided into phase I, II, III and IV. Clinical trials of drugs must be approved by nmpa and must comply with the code for quality management of clinical trials of drugs
Original drugs and original drugs refer to the first drugs approved for listing at home and abroad, and have complete and sufficient safety and effectiveness data as the basis for listing
Antineoplastic drugs and antineoplastic drugs refer to drugs that directly kill tumor cells
Preparation refers to the drugs that are made according to the dosage forms of photo agent, capsule agent and so on, and can be finally provided to the medication object for use
Tablet refers to the solid preparation of round or special-shaped tablets made of powdered drugs or an appropriate amount of excipients by mixing and pressing or other suitable methods
Kemena refers to the company’s product ektinib hydrochloride tablets
Ensartinib, ensatinib hydrochloride, x-396, x396, a new molecular entity compound with complete intellectual property rights from bemena, is a new generation of ALK inhibitor with strong effect and high selectivity, belonging to class 1 chemical drugs
Beianting refers to bevacizumab injection, mil60, which is used for the treatment of patients with metastatic colorectal cancer and advanced, metastatic or recurrent non-small cell lung cancer. It belongs to class 2 biological products for treatment
CM082, vorolanib, x82 are oral inhibitors targeting vascular endothelial growth factor receptor (VEGFR) and sectorlet-derived growth factor receptor (PDGFR)
EGFR refers to epidermal growth factor receptor
EGFR-TKI refers to EGFR tyrosine kinase inhibitor
Molecular targeting.
Tumor molecular targeting refers to the ability of therapeutic drugs to reach the important molecular targeting points of tumorigenesis, down regulate the expression of these receptors or the activation of downstream genes by binding with receptors or regulatory molecules, so as to achieve the programmed reversal of tumor cell differentiation, or indirectly target tumor neovascularization, Make tumor cells ischemic and produce apoptosis and necrosis
Small molecules refer to organic compounds with molecular weight less than 900 daltons and size in nanometer level (10 ^ – 9 meters) in the field of molecular biology and pharmacy
Macromolecule refers to a molecule with relatively high molecular weight, which is produced by the polymerization of multiple identical monomers with small molecular weight. It is generally believed that the molecular weight of macromolecules is greater than 10000 daltons
A malignant epithelial tumor consisting of small cells. It is named because the volume of cancer cells is relatively small compared with other tissue types. Its specific characteristics are as follows: the volume of cancer cells is small, the cancer cells are round or oval, and the finger shape of small cell lung cancer can also be spindle shape; The nucleus is located in the center, often with edges and corners; The chromatin is fine and diffuse, and the nucleolus is unclear; The cytoplasm is sparse and basophilic; Cancer cells are often diffusely distributed, or solid flakes, and large areas of necrosis are common
Non small cell lung cancer and NSCLC refer to the general name of all lung cancer tissue types except small cell lung cancer, including squamous cell carcinoma, adenocarcinoma and large cell carcinoma
ASCO refers to the American Society of clinical oncology
CSCO refers to the Chinese society of clinical oncology
Beta means beta Pharma Inc., a shareholder of the company
Beierda refers to Shanghai beierda Pharmaceutical Co., Ltd
Yuan and 10000 yuan refer to RMB yuan and 10000 yuan, unless otherwise stated in the text
Section II Company Profile and main financial indicators
1、 Company information
Stock abbreviation Betta Pharmaceuticals Co.Ltd(300558) stock code Betta Pharmaceuticals Co.Ltd(300558)
Chinese name of the company Betta Pharmaceuticals Co.Ltd(300558)
Chinese abbreviation of the company Betta Pharmaceuticals Co.Ltd(300558)
The foreign language name of the company is Betta Pharmaceuticals Co., Ltd
Legal representative of the company: Ding lieming
Registered address: No. 355, Xingzhong Road, Yuhang Economic and Technological Development Zone, Hangzhou, Zhejiang
Postal code of registered address 311100
The historical change of the registered address of the company was changed from No. 589, Hongfeng Road, Yuhang Economic and Technological Development Zone, Hangzhou to No. 355, Xingzhong Road, Yuhang Economic and Technological Development Zone, Hangzhou, Zhejiang Province on May 14, 2019
Office address: No. 355, Xingzhong Road, Yuhang Economic and Technological Development Zone, Hangzhou, Zhejiang
Postal code of office address 311100
The company’s Internet website is www.bettapharma.com com.
E-mail [email protected].
2、 Contact person and contact information
