Shanghai Junshi Biosciences Co.Ltd(688180)
(room 1003, 10th floor, building 2, No. 36 and 58, Haiqu Road, China (Shanghai) pilot Free Trade Zone) issued A-share shares to specific objects in 2022
Feasibility analysis report on the use of raised funds
March, 2002
1、 Use plan of the raised funds
The total amount of A-Shares issued to specific objects (including issuance expenses) does not exceed 3.980 billion yuan (including this amount), which are all cash subscription. The net amount of the total amount of funds raised after deducting issuance expenses will be used in the following directions:
Unit: 10000 yuan
No. total investment of the project raised funds to be invested
forehead
1 innovative drug R & D project 4 Hangzhou Xzb Tech Co.Ltd(603040) 036822000
2 Shanghai Shanghai Junshi Biosciences Co.Ltd(688180) science and technology headquarters and R & D base project 120588 Sichuan Anning Iron And Titanium Co.Ltd(002978) 000
Total 5808920039800000
After the raised funds of this offering are in place, if the actual net amount of raised funds is less than the above amount of raised funds to be invested, the board of directors and its authorized persons of the company will, according to the actual net amount of raised funds and on the premise of complying with relevant laws and regulations, within the scope of the above investment projects of raised funds, according to the progress of the investment projects of raised funds and the actual situation of capital demand, Adjust and finally determine the specific investment projects and priorities of the raised funds and the specific investment amount of each project. The insufficient part of the raised funds shall be solved by the company with its own funds or through other financing methods.
In order to ensure the smooth progress of the investment projects with raised funds and protect the interests of all shareholders of the company, before the funds raised in this issuance are in place, the company can invest with self raised funds according to the actual situation of the investment projects with raised funds, and replace them according to the provisions of relevant laws and regulations after the funds raised are in place.
If the total amount of funds raised by this issuance to specific objects is adjusted due to changes in regulatory policies or the requirements of issuance registration documents, it will be adjusted accordingly at that time. 2、 Specific use of funds raised from the project (I) basic information of the project (1)
In order to meet the growing demand of the biological drug market, promote the R & D process of the company’s innovative drugs, expand the development space of the company, consolidate and further improve the company’s core competitiveness, the company plans to use the raised funds of 3682.2 million yuan for the clinical research and preclinical research of innovative drugs, including js001 follow-up domestic and overseas clinical research and development, js004 domestic and overseas phase III clinical research and development Js111 preclinical research of clinical R & D projects at home and abroad and other early projects.
The project will further enrich the pipeline of the company’s drug products under research, quickly promote the domestic and foreign clinical trials of drugs in the clinical stage, promote the development of preclinical drugs, and lay a foundation for accelerating the listing and registration process of products under research. (2) Shanghai Shanghai Junshi Biosciences Co.Ltd(688180) science and technology headquarters and R & D base project
The project plans to establish Shanghai headquarters and R & D center in Shanghai Xi’An International Medical Investment Company Limited(000516) Park in Shanghai Zhangjiang Science City. The total investment of the project is 120588 million yuan, and the raised fund is planned to be 297.8 million yuan. The total area of the project plot is about 24.4 mu, and the total planned construction area is about 78331 m2.
After the completion of the project, it will become the company’s Shanghai R & D center, which integrates the functions of drug discovery and identification, functional verification, process development and test, meets the company’s R & D needs in the preclinical stage of innovative drugs and the office needs of clinical research design and implementation personnel from the level of hardware facilities, and provides a more perfect and resource rich working platform for R & D personnel, Enhancing the coordination of R & D departments of Shanghai headquarters is more conducive to attracting excellent R & D talents and thickening the R & D talent reserve of the company. The Shanghai R & D center will mainly involve four business segments, including new drug target research, antibody discovery and screening optimization research, production process amplification and optimization technology research, and new biotechnology research. 2. Project operation prospect
The company’s biological innovative drug industry is a technology intensive and capital intensive industry. The development of biological innovative drugs is a long, complex and expensive process, which needs several years of research and development, involving pharmaceutical chemistry, molecular and cell biology, crystal physics, statistics, clinical medicine and other fields, with an investment of tens of millions of dollars to hundreds of millions of dollars. The fund-raising investment project is formulated by the company on the basis of studying and judging the demand for biological innovative drugs in China’s foreign market and the development trend of biological drug research and development, so as to better grasp the market opportunities brought by the growth of biological drug industry. The company further increased the investment in innovative drug R & D, improved the hardware facilities related to scientific research, and promoted the effective integration of innovative drug R & D resources, which is in line with the development trend of the industry. Through the implementation of the fund-raising investment project, the business prospects of the company’s main business and products are analyzed as follows:
(1) The biopharmaceutical industry is growing year by year
With the improvement of Chinese residents’ economic level and health awareness, China’s demand for biological drugs is increasing, and the Chinese government’s investment in the biological industry is increasing. It is expected that the market scale of China’s biomedical industry will continue to grow rapidly. China’s biopharmaceutical market reached 345.7 billion yuan in 2020. According to frost Sullivan’s prediction, the scale of China’s biopharmaceutical market is expected to reach 811.6 billion yuan by 2025, and the annual compound growth rate from 2020 to 2025 is expected to be 18.6%.
The global biopharmaceutical market has increased from US $220.2 billion in 2016 to US $297.9 billion in 2020, with a CAGR of 7.8% from 2016 to 2020. Driven by factors such as the expansion of patient population and the improvement of payment ability, the growth rate of biological drug market in the future will be much higher than that of chemical drug market in the same period. According to frost Sullivan’s prediction, the global biological drug market is expected to reach US $530.1 billion by 2025, and the annual compound growth rate from 2020 to 2025 is expected to be 12.2%. (2) Policies to encourage and promote domestic substitution of innovative drugs
At present, the overall market of innovative drugs accounts for about 7.3% in China’s public drug terminal market. Compared with developed regions such as Europe, America and Japan, there is still much room for improvement.
With the continuous improvement of the pharmaceutical examination, industrial environment (financing channels, CRO, CMO) and payment terminal (medical insurance payment, commercial insurance) closely related to innovative drugs, the overall market space of innovative drugs will continue to grow rapidly in the future.
The company is an innovation driven biopharmaceutical company. Through the implementation of the fund-raising investment project, the company will promote the R & D process of drugs under research, enrich the product pipeline of drugs under research, improve the synergy of various R & D departments, effectively integrate R & D resources, enhance the R & D strength of innovative drugs, and better meet the strong demand of the market. 3. Relationship with existing business or development strategy
The company is an innovation driven biopharmaceutical company, mainly engaged in the discovery of innovative drugs, global clinical research and development, large-scale production and commercialization. The company’s innovative research and development field has expanded from monoclonal antibody drugs to more types of drug research and development, including small molecule drugs, polypeptide drugs, antibody drug conjugates (ADCs), bispecific or multispecific antibody drugs, nucleic acid drugs and the exploration of the next generation of innovative therapies for cancer and autoimmune diseases. The investment project of the raised funds is carried out closely around the company’s main business, which is the improvement and expansion of the company’s existing business and lays a solid foundation for the company to achieve medium and long-term strategic development goals.
After the completion of the project invested by the raised funds, the company’s current R & D, procurement, production, sales and other production
The business model will not change significantly. With the implementation of various raised investment projects, the company will further promote innovative medicine
The research and development process of drugs, enrich the pipeline of drug products under research, enhance the research and development strength, and further enhance the core competitiveness of the company
competitive power. Among them, the innovative drug R & D project will accelerate the company’s innovative drug R & D process and expand the company’s drug research
The breadth and depth of clinical trials will lay the foundation for the company to realize more commercialized products; Shanghai Junshi
The biotechnology headquarters and R & D base project will be built into the company’s Shanghai headquarters and R & D center, from the level of hardware facilities
Meet the R & D needs of the company’s innovative drugs in the preclinical stage and the office needs of clinical research design and implementation personnel, and increase
Add the synergy of various R & D departments of Shanghai headquarters, improve the effective integration of R & D resources and attract excellent R & D talents,
Provide accumulation for the long-term development of the company.
4. Implementation preparation and progress of the project
(1) Innovative drug R & D project
The main body of the project is the company or its holding subsidiary, and the total planned investment is 460304 million yuan. his
Among them, 3682.2 million yuan of raised funds are proposed to be invested, and the rest are invested with self raised funds. The investment details are as follows:
Unit: 10000 yuan
Summary of research contents of R & D project target stage progress investment amount proposed to use the amount of raised funds
Js001 combined with standard chemotherapy vs placebo phase III clinical study
Combined with standard chemotherapy for the stomach or gastroesophageal study group
Postoperative adjuvant therapy for adenocarcinoma of the junction
International multicenter phase III clinical study
Js001 js001 combined with renvatinib and standard chemotherapy
Phase III clinical trial of first-line treatment of non-compliance with standard chemotherapy regimen
Internal and external research on PD-1 resectable advanced intrahepatic cholangiocarcinoma preparation for national trial 93315008 Shanghai Pudong Development Bank Co.Ltd(600000) clinical hairline multicenter phase III clinical study
R & D phase II clinical research
Project js001 is used for surgically advanced head study
The international standard of perioperative treatment for cervical squamous cell carcinoma is phase III
Multi center phase III clinical research bed entry preparation
stage
Phase I / II clinical research
Js004, js004 combined with js001 and standard treatment were included in the study group
BTLA at home and abroad is in the international multi center of advanced non-small cell lung cancer, and the phase III clinical research bed of phase III Pro 86650008650000 R & D center is ready
stage
Phase I / II clinical research
Js004 combined with js001 and standard treatment were included in the study group
In the international multi-stage of extensive small cell lung cancer, stage III is imminent
Preparation of phase III clinical research bed of the center
stage
Phase I / II clinical research
Js004 combined with js001 in the treatment of relapsed refractory patients were included in the study group
International multicenter phase III clinical and phase III clinical of lymphoma
Study bed entry preparation
stage
