Securities code: 301096 securities abbreviation: Baicheng pharmaceutical Announcement No.: 2022020 summary of 2021 annual report of Hangzhou Baicheng Pharmaceutical Technology Co., Ltd. I. important tips: the summary of this annual report is 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 shall carefully read the full text of the annual report in the media designated by the CSRC. The audit opinion of Tianjian Certified Public Accountants (special general partnership) on the company’s financial report this year is: standard unqualified opinion. Tips on non-standard audit opinions □ applicable √ not applicable the company was not profitable at the time of listing and is not profitable at present □ applicable √ not applicable to the profit distribution plan of common stock or the plan of converting accumulation fund into share capital in the reporting period considered by the board of directors √ applicable □ not applicable
The company’s profit distribution plan for ordinary shares reviewed and approved by the board of directors is: taking 108166667 shares as the base, distribute cash dividends of 6.00 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.
Preferred stock profit distribution plan for the reporting period adopted by the board of directors □ applicable √ not applicable II. Basic information of the company 1. Company profile
Stock abbreviation: Baicheng Pharmaceutical Stock Code: 301096
Shenzhen Stock Exchange
Contact person and contact information secretary of the board of directors securities affairs representative
Name: you Minwei, Xu Yi
Office address: 611 Dongguan Road, Puyan street, Binjiang District, Hangzhou, Zhejiang Province
Fax: 057187923909
Tel: 057187923909
E-mail stock@hzbio -s.com. stock@hzbio -s.com.
2. Introduction to main business or products in the reporting period I. industry of the company during the reporting period (I) current situation of the industry of the company
The company’s main business covers generic drugs, comprehensive R & D services (CRO business), customized R & D and production services (cdmo business), transformation of R & D technological achievements and innovative drug R & D. the service content mainly includes pharmaceutical research, clinical trials, customized production, registration and declaration and other integrated whole industry chain services. According to the industry classification guidelines for listed companies (revised in 2012) issued by China Securities Regulatory Commission, the pharmaceutical R & D Services engaged by the company belong to “73 research and experimental development” (M73) under the category of “m scientific research and technical service industry”.
1. Cro industry development overview
The cro industry started earlier abroad and originated in the United States in the 1970s. With the complexity of drug research and development in the United States and the fierce competition in the pharmaceutical industry, pharmaceutical enterprises have gradually outsourced R & D in order to reduce costs and risks, superimposed with the continuous investment in global drug research and development and other factors, the cro industry has grown rapidly in the past few decades. According to frost Sullivan data, the global cro market scale increased from US $40.1 billion in 2014 to US $57.9 billion in 2018, with a CAGR of 9.7%. It is expected that the global market scale will reach US $95.2 billion by 2023, with a CAGR of 10.3%.
China’s cro is an emerging industry developed in recent 20 years. In recent years, the national pharmaceutical policy has been gradually improved, and the medical reform and pharmaceutical market have been gradually expanded, providing a broad market space for the whole drug and medical machinery. At the same time, in order to quickly seize the market share, Chinese and foreign pharmaceutical enterprises have invested a lot of R & D expenses to share the dividends of the rapid development of the pharmaceutical industry. As an important part of the pharmaceutical industry, cro also ushers in important development opportunities. China’s cro market is still small, but it is growing significantly faster than the global average. According to frost Sullivan, the size of China’s cro market increased from US $2.1 billion in 2014 to US $5.9 billion in 2018, with an average annual compound growth rate of 29.2% from 2014 to 2018. It is expected to grow to US $21.4 billion by 2023, with an average annual compound growth rate of about 29.6% from 2018 to 2023.
2. Development of cdmo industry
Under the background of specialization in the global pharmaceutical industry, the market scale of pharmaceutical cdmo industry has achieved rapid growth. Since 2016, the market scale growth of global pharmaceutical cdmo industry is as follows:
Global pharmaceutical cdmo market scale from 2016 to 2025
According to frost Sullivan data, from 2016 to 2020, the global pharmaceutical cdmo market scale increased from US $35.3 billion to US $55.5 billion, with an average annual compound growth rate of 11.98%. The global pharmaceutical cdmo market is mainly composed of chemical drugs and biological drugs. From 2016 to 2020, the global chemical cdmo market increased from US $25.9 billion to US $37.5 billion, with an average annual compound growth rate of 9.69%. According to frost Sullivan’s prediction, the global pharmaceutical cdmo market will maintain an average annual growth rate of 13.94% in the next five years, and the market scale will reach 106.6 billion US dollars in 2025; The global chemical cdmo market will maintain an average annual growth rate of 10.07%, and the market scale will reach US $60.6 billion in 2025.
In recent years, the global pharmaceutical outsourcing service market has gradually shifted to emerging markets. Driven by the interests of international pharmaceutical enterprises in reducing R & D and production costs and improving economic benefits, the continuous improvement of China Meheco Group Co.Ltd(600056) industry regulations and policies, and the significant improvement of China Meheco Group Co.Ltd(600056) cdmo service level, the scale of China’s cdmo market has increased to a greater extent, The growth rate of China’s cdmo industry is much higher than the global average.
20162025 China Meheco Group Co.Ltd(600056) cdmo market scale
According to frost Sullivan data, from 2016 to 2020, China Meheco Group Co.Ltd(600056) cdmo market scale increased from 10.5 billion yuan to 31.7 billion yuan, with an average annual compound growth rate of 31.82% China National Chemical Engineering Co.Ltd(601117) drug cdmo market scale increased from 8 billion yuan to 22.6 billion yuan, with an average annual compound growth rate of 29.64%. According to frost Sullivan’s prediction, the China Meheco Group Co.Ltd(600056) cdmo market will maintain an average annual growth rate of 31.26% in the next five years, and the market scale will reach 123.5 billion yuan in 2025 China National Chemical Engineering Co.Ltd(601117) drug cdmo market will maintain an average annual growth rate of 28.02%, and the market scale will reach 77.7 billion yuan in 2025.
(II) industry position of the company
Since its establishment, the company has attached great importance to the construction of R & D platform. With years of technology accumulation and R & D investment, the company has built platforms for innovative drug R & D, generic drugs and consistency evaluation, pharmaceutical research, be / PK research, compatibility and impurity research, and deeply arranged high-end preparation fields such as inhalation preparations, transdermal preparations, sustained and controlled release preparations and fine particles, Formed a strong core competitive advantage. As of December 31, 2021, the company has 18000m2 laboratory and office area, 765 employees, equipped with various advanced instruments and equipment, and established a perfect drug R & D system and quality assurance system. With the rapid progress of the construction project of Baicheng pharmaceutical headquarters and R & D center, a 46.18 Mu raised investment project of the company located in Linping District, Hangzhou, it is expected to be delivered and put into use in the middle of 2023. At that time, the newly built laboratory and office area of the company will reach 73900 m2, and the company will have enough space to accommodate the increasing R & D personnel to meet the increasing R & D orders of customers. In addition, Zhejiang Saimo, a wholly-owned subsidiary of the company, is located in the customized R & D and production service base in Jinhua Jinxi development zone. At present, the construction area of the base is more than 180 Mu and the construction plant area is 137100 square meters. As of December 31, 2021, the cumulative investment of the base is 437804 million yuan, the plant area that has been put into use is 8917240 m2, and 12 drug R & D and production lines have been built, Zhejiang Saimo has complete production equipment and perfect R & D and production quality management system, which can provide customers with efficient and high-quality customized production and R & D services. In the second half of 2021, Zhejiang Saimo’s cdmo business achieved an external revenue of 9.4014 million yuan, internally provided cdmo services for the company’s 57 entrusted R & D projects, made a phased breakthrough, and laid a solid foundation for the company’s double-line expansion of cro business and cdmo business in the future and further enhance the R & D value.
At the same time, the technical standards are in line with international standards in clinical trials and registration applications. According to the latest requirements of the State Food and drug administration, the company has built a be / PK platform. All instruments and systems have been verified by IQ, OQ and PQ and have audit tracking function. Clinical trials, sample testing and data statistics are electronically managed by internationally recognized trialone, Watson LIMS, SAS and winnonlin systems, Strict quality management system and on-site QA supervision mechanism provide comprehensive compliance guarantee for data. The company’s clinical trial platform has biological sample analysis laboratory, clinical site management team, scheme writing, data management & Statistics and other technical teams. It has established strategic cooperative relations with many clinical trial bases in China, which can provide customers with stable and efficient clinical trial services; In addition, the company has introduced the Cune ectd registration and declaration system, which complies with the trend of registration and declaration and is in line with international drug registration. The system integrates the verification standards used by the State Drug Administration, complies with the latest ICH specifications, supports regional standards for drug registration and declaration (US, EU, CA, JP, etc.) and various declaration types (NDA, ind, anda, etc.) of more than 40 countries / institutions around the world, and can meet the declaration needs of customers at home, abroad, such as China, the United States and Europe.
After years of development and accumulation, the company has great advantages in business scale, technical talents, business experience, technical level, equipment and facilities, quality control and customer resources. Based on its strong R & D strength and rich technical achievements, the company has been rated as a national “high-tech enterprise”, “provincial high-tech enterprise research and development center”, “Zhejiang high growth high-tech small and medium-sized enterprise” and “provincial enterprise research institute”. At present, it is a professional pharmaceutical R & D institution with strong scientific research ability and market influence in China, It has a high market position.
2、 Main businesses of the company during the reporting period
1. Main business of the company
The company is a comprehensive pharmaceutical R & D enterprise with technology development as the core. It mainly provides various pharmaceutical enterprises and pharmaceutical R & D Investment Enterprises: (1) pharmaceutical technology entrusted R & D Service (CRO business); (2) R & D technology achievement transformation service; (3) Customized R & D and production services (cdmo).
The company’s business covers the whole chain of drug R & D and production, such as drug discovery, pharmaceutical research, clinical trials, customized R & D and production, registration application and so on.
(1) Pharmaceutical technology entrusted R & D services (CRO business)
① Pharmaceutical research
Pharmaceutical research is an important part of drug research and development, which mainly includes the synthesis process of API, formulation process and quality research, so as to realize the transformation from compound to drug and drug. It is the premise of drug research of innovative drugs and the cornerstone of generic drug research and development or evaluation of quality and efficacy consistency of generic drugs, It is the research basis to ensure the effectiveness and safety of drugs. The company mainly provides research on the synthetic process of API, selection and specification confirmation of formulation, formulation process, quality, drug stability, impurities, compatibility of packaging materials / production pipelines / appliances, sealing of packaging system, etc.
② Clinical trial
Drug clinical trial refers to the drug research carried out in human body (patients or healthy subjects) for the purpose of drug registration, in order to determine the safety and effectiveness of drugs, with the purpose of discovering or verifying the clinical medical, pharmacological and other pharmacodynamic effects and adverse reactions of a test drug, or the absorption, distribution, metabolism and excretion of the test drug, Systematic trials to determine the efficacy and safety of drugs. Clinical trial services include bioequivalence (be) test, pharmacokinetics research, clinical trial of drugs and medical devices, etc. Bioequivalence (be) is a key index to evaluate the consistency of clinical efficacy of generic drugs. The clinical trial sponsor shall be the main sponsor of the clinical trial and participate in the analysis of clinical trial data (clinical trial report, clinical trial report, etc.) and the clinical trial manager shall assist in the preparation of clinical trial data.
③ Registration declaration
Drug registration refers to the approval process of systematically evaluating the safety, effectiveness and quality controllability of drugs to be listed according to the requirements of drug administration institutions (such as nmpa, FDA, EDQM and TGA), the application of drug registration applicants and legal procedures, and deciding whether to agree to their application. The company provides registration application services that meet the requirements of foreign application at the same time, including generic drug registration application (anda), DMF filing of raw materials, excipients and drug packaging materials, innovative drug clinical registration application (ind) and listing registration application (NDA), etc.
