Securities code: Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) securities abbreviation: Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266)
Suzhou Zelgen Biopharmaceuticals Co., Ltd.
(No. 209 CHENFENG Road, Yushan Town, Kunshan City, Jiangsu Province)
Issue A-Shares to specific objects in 2021
Feasibility analysis report on the use of raised funds
(Revised Version)
May, 2002
1、 Use plan of the raised funds
Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) (hereinafter referred to as ” Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) ” or “the company”) in order to further enhance its comprehensive competitiveness, according to the development needs of the company, the company plans to issue shares to specific objects, and the total amount of funds raised shall not exceed 1455290000 yuan (including this amount). After deducting the issuance expenses, the actually raised funds will be used for new drug R & D projects and phase III construction projects of new drug R & D and production center, as follows:
Unit: 10000 yuan
No. project name total amount of proposed investment amount of proposed raised funds
1 new drug R & D project 123110123110
2 phase III construction project of new drug R & D and production center 7258322419
Total 195693145529
Within the scope of the above-mentioned projects invested with raised funds, the company can appropriately adjust the investment sequence and specific amount of the corresponding projects invested with raised funds according to the actual situation such as the progress and capital demand of the project. Before the funds raised in this offering 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 in accordance with the procedures specified in relevant laws and regulations after the raised funds are in place. After the funds raised in this offering are in place, if the actual net amount of funds raised after deducting the issuance expenses is less than the total amount of funds to be invested, the board of directors and its authorized persons of the company can adjust and finally decide the investment projects, priority and specific investment amount of each project of the raised funds according to the authorization of the general meeting of shareholders, combined with the actual amount of funds raised and the specific situation of project implementation, and the insufficient part shall be solved by the company’s self raised funds.
If the total amount of funds raised in this offering is adjusted due to changes in regulatory policies or the requirements of the issuance registration documents, it will be adjusted accordingly at that time.
2、 Investment direction of the raised funds
(I) new drug R & D projects
1. Basic information of the project
The company is an innovation driven chemical and biological new drug R & D and production enterprise focusing on many treatment fields such as tumor, bleeding and blood diseases, hepatobiliary diseases and immune inflammatory diseases. Its goal is to become a leading enterprise in the R & D of new drugs in the fields of tumor, bleeding and blood diseases, hepatobiliary diseases and immune inflammatory diseases in China. The company’s market strategy is to face the world and focus on China, develop and produce innovative drugs with independent intellectual property rights, safety, effectiveness and affordable for patients, and meet the huge pharmaceutical market demand outside China.
The company has a new drug R & D technology platform at the international level. At the same time, it pays attention to international and Chinese technology and project cooperation and expansion. Relying on its R & D advantages in the fields of tumor, blood diseases and immune inflammatory diseases, the company provides patients with better (safer, more effective or more convenient) treatment options. The company plans to increase R & D investment and further promote the development of Jack tinib hydrochloride tablets, zg19018 tablets Zg005 powder injection and other new drug R & D process and global synchronous development, and promote the research of preclinical innovative drugs to expand the company’s product pipeline, so as to further enhance the differentiated competitive advantage of the company’s product pipeline.
The total investment of the new drug R & D project of the company is 1231.1 million yuan, and the investment of the raised funds to be used is 1231.1 million yuan. The raised funds of the project will be mainly used for the research and development of products under research with significant clinical progress, new products under research, expansion indications of existing products, R & D of international clinical trials of related products, as well as the verification and development of innovative drug targets, preclinical research and concept verification research of innovative drugs.
2. Necessity of project implementation
(1) Further layout of major diseases and rare diseases, expand and enrich the company’s R & D pipeline
The company distributes major diseases and rare diseases. The pipeline of products under research mainly covers the treatment fields of tumors, bleeding and blood diseases, hepatobiliary diseases and immune inflammatory diseases, filling the gap in China and providing treatment options for unmet clinical needs. The company’s new drug product pipeline has the characteristics of advanced technology, high production difficulty, obvious differentiation advantages, independent intellectual property rights, large market demand and so on. Since 2020, the company has further consolidated its scientific research achievements. As of the announcement date of this report, there are pipeline varieties of products under development such as donafenib toluenesulfonate tablets and Jack tinib hydrochloride tablets for malignant tumors, among which donafenib toluenesulfonate tablets have been approved for the first-line treatment of advanced liver cancer, Donafenib toluenesulfonate tablets for the treatment of locally advanced / metastatic radioiodine refractory differentiated thyroid cancer (rair-dtc) have submitted an application for marketing license. Donafenib toluenesulfonate tablets and their combination, Jack tinib hydrochloride tablets, recombinant human thyroid stimulating hormone and okatinib capsules are in different stages of clinical trials respectively. Zg19018 tablets and zg005 powder injection have been approved by nmpa and FDA for clinical trials, zg006 powder injection Zggs18 powder injection, zggs001 powder injection, gs11 powder injection and zg170607 injection are undergoing preclinical research; For immune inflammatory diseases, Jack tinib hydrochloride tablets and Jack tinib hydrochloride cream have entered the stage of clinical trials; For hepatobiliary diseases, magnesium obecholate tablets have entered the clinical trial stage; In the field of hemostasis, the application for marketing license of recombinant human thrombin for external use has been submitted, and zg1905 is in the stage of preclinical research; In addition, zg170607 cream for the treatment of viral diseases has entered the stage of preclinical research.
The smooth implementation of the project will benefit the following aspects:
① After the company’s listed product donafinil toluenesulfonate tablets, another heavy product, Jack tinib hydrochloride tablets, will be accelerated to develop a new indication other than the indication of bone marrow fibrosis in China, that is, moderate and severe atopic dermatitis and ankylosing spondylitis, and further expand the company’s competitive advantage in the field of JAK inhibitors.
② Since the IPO, the company has added a number of innovative product pipelines through independent research and development. Among them, zg19018 tablets and zg005 powder injection have successfully obtained the clinical trial approval of nmpa and FDA and entered the phase I clinical trial stage. Zggs18 powder injection, zg170607 injection, zg006 powder injection and gs11 powder injection are all in the preclinical research stage. The funds raised in this issuance will further enhance the company’s comprehensive competitive strength in the field of anti-tumor treatment.
③ Further enrich the company’s product pipeline under research, expand the company’s R & D breadth and depth in small molecule innovative drugs and innovative antibody products, help the company launch more first in class and best in class innovative drugs guided by clinical value, help the company successfully implement the core development strategy and maintain the healthy and sustainable development of the company.
(2) Accelerate the development progress of innovative drugs and improve the company’s core competitiveness
The company is an innovation driven new drug R & D company. Since its establishment, it has established the strategic goal of researching and developing innovative drugs with independent intellectual property rights, safety, effectiveness and affordable for patients. Since its establishment, the number of research projects of the company has continued to grow. In June 2021, the first-line treatment of advanced liver cancer with donafinil tablets was approved for listing; As of the announcement date of this report, the company has 42 major research projects of 16 major drugs under research, of which 8 indications of 4 drugs under research are in the stage of NDA, phase III or registered clinical trial, 5 drugs under research are in the stage of phase I or II clinical trial, and 7 drugs under research are in the stage of preclinical research and development, adding several new research projects compared with the company’s initial public offering. Meanwhile, the company’s subsidiary gensun will gs02 (tigit monoclonal antibody) and gs19 (PD-L1 / TGF)- β The Greater China rights and interests of the bispecific antibody) project are authorized to Qilu pharmaceutical and Kaifa pharmaceutical respectively.
The R & D of innovative drugs has the characteristics of great technical difficulty, long cycle, complex test and intensive capital investment, and also needs to meet the strict supervision and requirements of Chinese and foreign government agencies for clinical trials. The R & D cost is high. With the promotion of the company’s existing product pipeline under research and the continuous layout of new product pipeline, especially the company’s several projects are in the key stage of phase II / III, and the continuous increase of clinical trial cost The competition for innovative drug R & D is becoming increasingly fierce, and the company’s existing funds are difficult to meet the needs of rapidly promoting R & D projects. This project will invest in the research in progress products, new research in progress products, expansion indications of existing products, R & D of international clinical trials of related products, as well as the verification and development of innovative drug targets, preclinical research and conceptual verification research of innovative drugs, so as to ensure the smooth progress of the company’s clinical and preclinical projects and accelerate the process of product R & D and industrialization. The implementation of this project will expand the company’s source of funds, accelerate the company’s R & D process of innovative drugs, enhance the company’s independent R & D strength, improve the company’s core competitiveness, and promote the commercialization of more products as soon as possible, which is crucial to the company’s long-term development.
(3) Further implement the global layout of the company’s business and implement the international development strategy
The company’s development strategy is to continuously promote the clinical research and commercialization of products under research in China, actively allocate resources, give priority to the development of products under research close to commercialization, and actively layout the international development of the company’s products, so as to enhance the ability to participate in global competition and international cooperation. Relying on its product advantages, the company will carry out layout in the international market, gradually enhance the company’s internationalization ability, and further provide support for the innovative antibody research and development of gensun, an American subsidiary.
The company has formulated several international clinical trial plans for new drugs under development, among which the clinical trial of Jack tinib hydrochloride tablets for the treatment of indications of bone marrow fibrosis in the United States has been launched, and zg005 powder injection and zg19018 tablets have been approved by FDA. The implementation of this new drug R & D project will help accelerate the internationalization process of the company’s innovative drugs and lay a foundation for the company to further enhance its global competitiveness.
The company is in the biomedical industry related to the national economy and the people’s livelihood. The research and development of innovative drugs is not only conducive to promoting the transformation of China’s pharmaceutical pattern to independent innovation, but also conducive to accelerating the pace of “going global” of local innovative drugs, further opening up the international market of innovative drugs and accelerating the internationalization process.
3. Feasibility of project implementation
(1) National policies support the development of innovative drugs
In recent years, the Chinese government has attached great importance to the pharmaceutical industry and issued a number of policies to encourage the accelerated listing of imported and domestic innovative drugs. In 2016, the State Council issued the 13th five year plan for the development of national strategic emerging industries to encourage the accelerated development of innovative drugs and biological products with major clinical needs. In 2016, the Ministry of industry and information technology and other six departments jointly issued the guidelines for the development planning of pharmaceutical industry, which proposed to closely follow the development trend of international pharmaceutical technology, carry out the research and development of new drugs for major diseases, and focus on the development of innovative drugs for malignant tumors, especially new drugs with new targets and new action mechanisms.
In June 2016, the general office of the State Council issued the notice of the general office of the State Council on printing and distributing the pilot scheme of the drug listing license holder system. The scheme stipulates that drug R & D institutions or scientific researchers can submit drug clinical trial applications and drug listing applications as drug registration applicants. If the applicant obtains the drug listing license and drug approval number, he can become the drug listing license holder. In August 2019, the drug administration law of the people’s Republic of China was officially promulgated, and the drug marketing Licensor system (MAH) was incorporated for the first time. Under the MAH system, innovative drug enterprises can focus on the selection of R & D pipelines, preclinical and clinical research, which is conducive to accelerating the R & D of innovative drugs and improving the R & D efficiency.
In 2021, the National Medical Security Administration issued the work plan for the adjustment of the national medical insurance drug catalogue in 2021, which adjusted the medical insurance access time limit to June 30, 2021, and a batch of domestic drugs newly listed in 2021, including donafinil toluenesulfonate tablets, were included in this round of medical insurance negotiations. With the acceleration of medical insurance negotiations, innovative drug enterprises with strong R & D strength, sufficient R & D pipelines and facing scarce R & D fields are more likely to quickly achieve market share and large volume of products in the future, and innovative drug enterprises will have greater profit space.
The strong support of the state for the research and development of innovative drugs for major diseases provides good policy conditions for the implementation of the project, so the project has policy feasibility.
(2) The company has excellent R & D ability of innovative drugs
The company has excellent R & D ability of innovative drugs. As of the announcement date of this report, by making full use of its core technology, the company has presided over 5 major national science and technology projects of “major new drug creation” and nearly 10 provincial scientific research projects. The company has two independent R & D platforms: small molecule drug R & D and industrialization platform, complex recombinant protein biological new drug and antibody new drug R & D and industrialization platform, covering new drug discovery, pharmaceutical research, preclinical research, clinical research, drug registration and drug production, ensuring sustainable innovation ability and complete innovative drug R & D ability. The drugs under research in the nine clinical stages of the company come from the development of independent research and development platform.
Small molecule drug R & D and industrialization platform is the foundation of the company’s small molecule new drug R & D. One of the company’s core technologies is the world’s leading drug stabilization technology, which effectively ensures the success rate of new drug development. New drug research and development companies with different intellectual property rights, such as small-scale molecular screening, have adopted a variety of new drug research and development technologies, and have been in the stage of new drug research and development, structural simulation and other new products with independent intellectual property rights. The R & D and industrialization platform of complex recombinant protein biological new drugs and antibody new drugs is the basis of the company’s macromolecular new drug R & D. Through the self-developed core technology of complex recombinant protein, the company has taken the lead in successfully developing a number of recombinant protein drugs. Gensun, a subsidiary of the company, is engaged in the innovative research and development of antibody drugs in the field of tumor immunity, with tr
