Shenzhen Salubris Pharmaceuticals Co.Ltd(002294)
Annual report for 2021
March 2022
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.
Ye Chenghai, the person in charge of the company, Kong Yun, the person in charge of accounting, and Zhang Guiqing, the person in charge of the accounting organization (the person in charge of Accounting), declare that they guarantee the authenticity, accuracy and completeness of the financial report in this annual report.
No directors, supervisors or senior managers declare that they cannot guarantee or disagree with the authenticity, accuracy and completeness of the annual report.
All directors have attended the meeting of the board of directors to consider this report.
This annual report involves forward-looking statements such as future plans, which does 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.
The company invites investors to carefully read the full text of this annual report and pay special attention to the following risk factors: possible risks such as R & D failure, price decline and cost rise caused by policy changes. Relevant risk factors and countermeasures have been described in the "management discussion and analysis" section of this report. Please pay attention to investment risks.
The profit distribution plan approved by the board of directors is: Based on the total number of 1114816535 shares of the company as of December 31, 2021 and the total share capital of 1093589012 shares after deducting 21227523 shares held in the company's special securities account for repurchase, the company will distribute discovery bonus of 4.00 yuan (including tax) to all shareholders for every 10 shares, send bonus shares of 0 shares (including tax), and do not convert the accumulation fund into share capital.
Between the disclosure date of the annual report and the equity registration date of the profit distribution plan, if the total number of shares participating in the dividend changes due to share repurchase and other matters, the total share capital of the company after deducting the repurchased shares from the total number of shares on the equity registration date when the future distribution plan is implemented shall be used as the base, and the distribution proportion shall remain unchanged and the total distribution amount shall be adjusted.
√ audit opinion not applicable
Prompt of major defects in internal control □ applicable √ not applicable
Does the company need to comply with the disclosure requirements of special industries? No
catalogue
Section I important tips, contents and definitions Section 2 company profile and main financial indicators 8 section III Management Discussion and Analysis Section IV corporate governance 46 Section V environmental and social responsibility 84 section VI important matters Section VII changes in shares and shareholders 122 Section VIII preferred shares 138 section IX bond related information 139 section x financial report one hundred and forty
To shareholders
Dear shareholders
In 2021, Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) took a solid step in the journey of "innovation + internationalization". The preliminary data of the international patented product jk07, a US clinical trial, showed that it had good safety and potential clinical benefit signals compared with the placebo group; Ennasita completes the clinical and submits the application for production approval; Six new products entered phase III clinical stage; Business performance returned to the growth trend. All these mean that the company is coming out of the trough and starting a new journey!
Understand the changes and development of the pharmaceutical industry, understand the policy orientation, return to the essence of medicine and the original intention of engaging in the pharmaceutical industry. I believe many doubts will be solved. Before the elimination of human diseases, medicine is still the most certain sunrise industry; The original intention of the pharmaceutical industry is to alleviate and solve the pain caused by diseases, so that more patients can use high-quality and high-priced drugs and bring a healthy life to mankind. Therefore, whether from policy guidance, regulatory rules, medical insurance payment, patient demand, etc., they are consistent with the direction and objectives of pharmaceutical enterprises, and the market demand for pharmaceutical products will rise spirally. The confidence in the pharmaceutical industry is as firm as a rock and will never waver. I deeply believe that Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) people are engaged in a noble and sacred cause! I am particularly grateful to the majority of shareholders for their trust and support all the time!
In 2022, the reform process of the pharmaceutical industry is accelerating. After years of accumulation in the field of innovation, we have gradually entered the harvest period, and our future is infinitely bright! We have made a good start. Whether the clinical trial of innovative drugs is carried out smoothly or the bid winning of bidding procurement indicates that the dawn has come and is waiting for the dawn!
thank you!
Chairman Ye Chenghai March 2002
Directory of documents for future reference
1、 Financial statements containing the signatures and seals of the person in charge of the company, the person in charge of accounting work and the person in charge of accounting organization (Accounting Supervisor).
2、 The original of the audit report with the seal of the accounting firm and the signature and seal of the certified public accountant. 3、 Originals of all company documents and announcements publicly disclosed during the reporting period.
4、 The company's 2021 annual report with the signature of the chairman.
5、 Other relevant information.
The place where the original or legally effective copies of the above documents for future reference are prepared: the office of the Secretary of the board of directors of the headquarters of the company and Shenzhen Stock Exchange.
Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) Chairman: ye Chenghai
March 29, 2002
interpretation
Explanatory item refers to the explanatory content
The company, the company, Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) refers to Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) Hong Kong Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) and the controlling shareholder refers to Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) Pharmaceutical Co., Ltd. the controlling shareholder of the company is a company registered in Hong Kong
CSRC and CSRC refer to the China Securities Regulatory Commission
Shenzhen stock exchange refers to Shenzhen Stock Exchange
RMB / 10000 refers to RMB / 10000 unless otherwise specified
The national medical insurance catalogue refers to the catalogue of drugs for national basic medical insurance, industrial injury insurance and maternity insurance issued by the national medical insurance bureau and the Ministry of human resources and social security
Nmpa and FDA refer to the State Drug Administration
CDE refers to the drug evaluation center of the State Drug Administration
Ind refers to clinical trials of new drugs
GMP refers to the good manufacturing practice
The articles of association refers to the articles of association of Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) company
General meeting of shareholders refers to Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) general meeting of shareholders
Board of directors means the board of directors of Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) company
Board of supervisors refers to Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) board of supervisors
Xinlitan refers to the company's product, and the generic name of the drug is alisartan axetil tablets
Taijia refers to the company's product, and the general name of the drug is clopidogrel bisulfate tablets
Xinlixin refers to the company's product, and the general name of the drug is cefuroxime sodium for injection
Maurora ® Refers to the company's medical device products, rapamycin drug-eluting vertebral artery stent system
Jk07 and sal007 refer to the company's innovative biological drug "recombinant human neuromodulatory protein 1-anti HER3 antibody fusion protein injection"
Sal0107 and sal0108 refer to the company's innovative compound preparations "alisartan axetil amlodipine tablets" and "alisartan axetil indapamide sustained-release tablets", and their unilateral preparations are the company's innovative products xinlitan
HSE refers to the general term of health, safety and environment, occupational health and safety management system (OHSMS) and environmental management system (EMS)
Section II Company Profile and main financial indicators
1、 Company information
Stock abbreviation Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) stock code Shenzhen Salubris Pharmaceuticals Co.Ltd(002294)
Shenzhen Stock Exchange
Chinese name of the company Shenzhen Salubris Pharmaceuticals Co.Ltd(002294)
Chinese abbreviation of the company Shenzhen Salubris Pharmaceuticals Co.Ltd(002294)
Foreign language name of the company (if any) Shenzhen salubris Pharmaceuticals Co., Ltd
Abbreviation of the company's foreign name (if any) salubris
Legal representative of the company: ye Chenghai
Registered address: 37th floor, main building, chegongmiao Lvjing Plaza, No. 6009, Shennan Avenue, Futian District, Shenzhen
Postal code of registered address: 518040
According to the proposal on changing the registered address of the company deliberated and approved at the 2010 annual general meeting of shareholders, the registered address of the company was changed from "room 1901, 1902 and 1903, innovation and Exhibition Center, No. 6007, Shennan Avenue, Futian District, Shenzhen, and the historical change of the registered address of the company was room 1923" to "37 / F, main building of chegongmiao green view Plaza, No. 6009, Shennan Avenue, Futian District, Shenzhen".
In May 2011, the company completed the industrial and commercial registration procedures for the change of registered address in Shenzhen market supervision administration.
Office address: 37th floor, main building, chegongmiao Lvjing Plaza, No. 6009, Shennan Avenue, Futian District, Shenzhen
Postal code of office address: 518040
Company website http://www.salubris.com.
E-mail [email protected].
2、 Contact person and contact information
Secretary of the board of directors and securities affairs representative
Name: Yang Jianfeng
Contact address: Car 6009, Shennan Avenue, Futian District, Shenzhen
37th floor, main building of Gongmiao Lvjing square
Tel: 075583867888
Fax: 075583867338
E-mail [email protected].
3、 Information disclosure and preparation location
The website of the stock exchange where the company discloses the annual report Shenzhen Stock Exchange www.szse.com cn.
The media name and website of the annual report disclosed by the company are China Securities Journal, securities times and cninfo.com www.cn info. com. cn.
The company's annual report is prepared at the office of the Secretary of the board of directors of the company's headquarters and Shenzhen Stock Exchange
4、 Registration changes
Organization code 91440 Focus Lightings Tech Co.Ltd(300708) 453259j (Unified Social Credit Code)
In 2017, after the second meeting of the Fourth Board of directors and the 2016 annual general meeting of shareholders, the business scope of the company was changed: from "development, research and production of chemical APIs, powders, tablets and capsules. Import and export business of goods and technologies (excluding import and distribution business)." Change to "development, research and production of chemical APIs"
