Securities code: 688202 securities abbreviation: Shanghai Medicilon Inc(688202) Shanghai Medicilon Inc(688202)
(Building 5, Lane 67, libing Road, China (Shanghai) pilot Free Trade Zone)
Demonstration and analysis report on the scheme of issuing A-Shares to specific objects in 2022
February, 2002
Shanghai Medicilon Inc(688202) (hereinafter referred to as the “company”) is a company listed on the science and Innovation Board of Shanghai Stock Exchange. In order to meet the capital needs of the company’s business development, enhance the company’s capital strength and enhance its profitability, in accordance with the provisions of relevant laws, regulations and normative documents such as the company law, the securities law, the articles of association and the measures for the administration of securities issuance and registration of companies listed on the science and Innovation Board (for Trial Implementation) (hereinafter referred to as the “measures for the administration of registration”) issued by the CSRC, The company plans to issue A-Shares to specific objects, and the raised funds shall not exceed 2160 million yuan (including this amount).
(unless otherwise specified in this report, relevant terms have the same meanings as those in the plan for issuing A-Shares to specific objects in Shanghai Medicilon Inc(688202) 2022.) 1、 Background and purpose of this offering
(I) background of this issuance
1. Global drug R & D expenditure continued to grow, and cro penetration continued to improve
Drug research and development is the foundation of the development of the pharmaceutical industry. Pharmaceutical innovation can not only provide long-term driving force for economic development, but also the fundamental requirement to solve the problems of people’s livelihood. The importance of new drug research and development is that once successful, it will bring significant social benefits and help to improve the health of all mankind. In recent years, with the increasing willingness of pharmaceutical consumption and the continuous breakthrough of new therapies, the global drug R & D expenditure has continued to rise. According to Frost & Sullivan’s data, the global drug R & D expenditure continued to grow from 2016 to 2020, with an average annual compound growth rate of 6.9%; It is expected that the growth rate of global drug R & D expenditure will further increase from 2020 to 2025, and the overall compound growth rate will reach 7.6%.
Global drug R & D expenditure from 2016 to 2025
(unit: USD 100 million)
3,500
3,000 2,779 2,954
2,421 2,599 225 249
2,500 2,241 184 204
2,048 166
2,000 1,651 1,740 1,824 151 1,151 1,224
1,567 123 138 1,002 1,077
1,500 92 105 843 927
635 681 728 772
1,000
1,148 1,235 1,316 1,403 1,481
500 840 865 889 914 1,054
0
2016 2017 2018 2019 2020 2021E 2022E 2023E 2024E 2025E
Large pharmaceutical enterprises, medium-sized pharmaceutical enterprises and small innovative drug enterprises
Source: Frost & Sullivan
Large and medium-sized pharmaceutical enterprises are the main source of drug R & D demand and contribute most of the global drug R & D expenditure every year. According to Frost & Sullivan’s data, the annual drug R & D expenditure of global large and medium-sized pharmaceutical enterprises accounts for more than 90% of the global drug R & D expenditure. Large and medium-sized pharmaceutical enterprises have entered a relatively mature stage of development, and have the strength to invest more R & D expenditure in new drug R & D, so as to consolidate their market position by continuously developing new drug varieties. While conducting internal R & D, large and medium-sized pharmaceutical enterprises also purchase a large number of R & D services from professional external drug R & D service institutions, so as to avoid the risk of decline in marginal R & D efficiency caused by relying solely on internal R & D, improve their overall R & D efficiency and control R & D costs. The long-term, stable and large-scale R & D service demand of large and medium-sized pharmaceutical enterprises is the sustainable driving force for the development of cro enterprises. In recent years, driven by favorable policies and increased attention from the capital market, the number and R & D expenditure of small innovative drug enterprises have increased rapidly. According to Frost & Sullivan’s data, the R & D expenditure of global small innovative drug companies increased from US $9.2 billion in 2016 to US $15.1 billion in 2020, with an average annual compound growth rate of 13.3%. It is expected to increase to US $24.9 billion by 2025 and a compound growth rate of 10.5% from 2020 to 2025. Compared with medium-sized and large pharmaceutical enterprises, small innovative drug enterprises are usually more cautious about investment in fixed assets and investment in their own R & D personnel, and rely more on professional external drug R & D service organization cro to realize drug R & D, which has brought broad market opportunities to the cro industry.
Cro industry penetration in 2020-2024
50%
42.3% 43.3%
40% 35.2% 35.5%
30%
20%
10%
0%
Cro industry drug discovery
2020 2024E
Data source: Frost & Sullivan
Based on the advantages of cro enterprises in improving R & D success rate, controlling R & D cost and shortening R & D cycle in the process of new drug R & D, the recognition of cro enterprises at home and abroad continues to improve, and the penetration rate of global cro industry is also steadily increasing.
According to Frost & Sullivan’s data, the overall market penetration of global cro and drug discovery in 2020 were 35.2% and 35.5% respectively, and it is expected to increase to 42.3% and 43.3% respectively by 2024. The market penetration of drug discovery cro is higher than that of cro as a whole.
2. Drug regulatory reform and favorable policies continued to be introduced, promoting the rapid expansion of China’s cro market
The pharmaceutical industry has strong policy oriented characteristics. The early China Meheco Group Co.Ltd(600056) market is mainly generic drugs, the R & D power of innovative drugs is insufficient, and the market demand for cro is relatively low. In recent years, a series of policies issued at the national level will promote the research and development of innovative drugs in China and promote the upgrading of the pharmaceutical industry from imitation to independent innovation. After the State Council’s opinions on reforming the review and approval system of drugs and medical devices (GF [2015] No. 44) and the opinions on deepening the reform of the review and approval system and encouraging innovation of drugs and medical devices (Ting Zi [2017] No. 42) issued by the general office of the CPC Central Committee and the general office of the State Council, the State Drug Administration encouraged drug R & D and innovation In terms of improving drug quality, we will continue to promote the reform of the review and approval system to provide a good policy environment for innovative drug research and development.
In August 2019, the 12th meeting of the Standing Committee of the 13th National People’s Congress revised and adopted the drug administration law of the people’s Republic of China, fully implemented the drug marketing license holder (MAH) system, adopted the management model of separating drug marketing license from production license, and further optimized the resource allocation efficiency of the pharmaceutical industry, Allow small and medium-sized biomedical companies without production capacity or large pharmaceutical enterprises with production capacity transfer demand to cooperate with cro enterprises to speed up the process of drug R & D and commercialization.
In addition, in recent years, with the intensive introduction of a series of favorable policies such as the consistency evaluation of generic drugs, China’s formal accession to ICH and the reform of medical insurance payment system, the demand of pharmaceutical enterprises for drug R & D services has been stimulated, the specialization of the pharmaceutical industry has been further promoted, and the continuous growth of China Meheco Group Co.Ltd(600056) R & D service industry has been driven. 3. The innovation of local pharmaceutical enterprises is changing with each passing day, and the demand for cro is strong
In recent years, with the change of the policy orientation of the pharmaceutical industry and the attention of the capital market to the pharmaceutical industry, China’s large pharmaceutical enterprises and small and medium-sized biomedical enterprises have increased their investment in the field of innovative drugs. According to Frost & Sullivan’s data, China’s R & D expenditure on drugs has rapidly increased from 78.8 billion yuan in 2016 to 170.3 billion yuan in 2020, with an average annual compound growth rate of 21.3%. It is expected to further increase to 342.3 billion yuan by 2025 and 15.0% from 2020 to 2025. This growth rate will be much higher than the global average growth rate.
China’s drug R & D expenditure from 2016 to 2025
(unit: 100 million yuan)
4,000
3,500
3,000 520
460 640
2,500 410 570
2,000 350 500
310 440
1,500 210 250 390
170 280 320 2,260
1,000 210100 220 1,570 1,790 2,030
500 116000 970 1,130 1,370
530 650 770
0
2016 2017 2018 2019 2020 2021E 2022E 2023E 2024E 2025E
Clinical study preclinical study drug discovery
Source: Frost & Sullivan
The industry environment that encourages innovation and the rapid development of biomedical investment and financing have significantly developed the R & D and innovation of innovative drugs in China. According to the annual drug review report issued by the drug review center (CDE) of the State Drug Administration, the number of ind applications for class 1 new drugs of China National Chemical Engineering Co.Ltd(601117) drugs and biological drugs has increased significantly since 2019. The R & D expenditure of class 1 new drugs far exceeds that of generic drugs and other drugs. In the future, with the further increase of the varieties of innovative drugs, it will bring more obvious demand for drug R & D services to the cro industry and promote the further development of the cro industry.
Ind applications for class 1 new drugs in China from 2011 to 2020
eight hundred