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)
Demonstration and analysis report on the issuance scheme of A-Shares issued to specific objects in 2021
(Revised Version)
May, 2002
Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) (hereinafter referred to as " Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) " or "company") is a listed company on the science and Innovation Board of Shanghai Stock Exchange. In order to meet the capital needs of the company's business development and enhance the company's capital strength and profitability, in accordance with the provisions of the company law of the people's Republic of China, the securities law of the people's Republic of China, 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") and other relevant laws, administrative regulations, departmental rules or normative documents, as well as the Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) articles of association, The company has prepared the demonstration and analysis report on the issuance plan of issuing A-Shares to specific objects in Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) 2021 (Revised) (hereinafter referred to as the "demonstration and analysis report").
Unless otherwise specified in this demonstration and analysis report, relevant terms have the same meaning as in the plan for issuing A-Shares to specific objects in Suzhou Zelgen Biopharmaceuticals Co.Ltd(688266) 2021 (Revised Version).
1、 Background of this issuance of shares to specific objects
(I) broad prospects for the development of Chinese and global pharmaceutical markets
The intensification of global aging, the increase of social medical and health expenditure and the increase of R & D investment in the pharmaceutical industry are the key factors driving the development of the global pharmaceutical industry. The scale of the global pharmaceutical market has maintained steady growth in the past, from US $1.2 trillion in 2016 to US $1.3 trillion in 2020. According to Frost & Sullivan, the global pharmaceutical market will reach US $2.1 trillion by 2030. According to the data of China's National Bureau of statistics, from 2016 to 2020, China's population over the age of 65 increased from 150 million to 190 million, accounting for 13.5% of the total population by the end of 2020 The China Meheco Group Co.Ltd(600056) market has grown rapidly in the past few years with a growth rate exceeding that of the global pharmaceutical market: in 2016, China Meheco Group Co.Ltd(600056) market reached 1.3 trillion yuan, in 2019 reached 1.6 trillion yuan, and in 2020, it decreased to 1.4 trillion yuan due to the impact of covid-19 epidemic. According to Frost & Sullivan's prediction, China Meheco Group Co.Ltd(600056) market will maintain rapid growth in the future and reach 3.0 trillion yuan in 2030.
In terms of sub sectors, the global market for cancer small molecule targeted drugs and biological drugs has maintained stable growth. The global market for cancer small molecule targeted drugs has increased from US $31.3 billion in 2016 to US $54.2 billion in 2020. According to Frost & Sullivan's prediction, it will reach US $147 billion in 2030; The global biopharmaceutical market has increased from US $220.2 billion in 2016 to US $297 billion in 2020. Frost & Sullivan predicts that it will reach US $804.9 billion in 2030. China's cancer small molecule targeted drugs and biological drugs market has achieved explosive growth in the past few years. China's cancer small molecule targeted drugs market has increased from 8.5 billion yuan in 2016 to 37.5 billion yuan in 2020. According to Frost & Sullivan's prediction, it will reach 207 billion yuan in 2030; China's biopharmaceutical market has increased from 183.6 billion yuan in 2016 to 345.7 billion yuan in 2020. According to Frost & Sullivan's prediction, it will reach 1294.3 billion yuan in 2030.
(II) innovative drugs continue to develop under the promotion of the policy reform of the pharmaceutical industry
In recent years, China Meheco Group Co.Ltd(600056) industrial policies are undergoing continuous changes, and the R & D environment of innovative drugs continues to usher in favorable changes. Innovative pharmaceutical enterprises with real innovation ability and core competitiveness have ushered in historic development opportunities. In 2020, China promulgated or revised a series of policies or rules on priority review and approval of innovative drugs, patent compensation, data protection, clinical trial specification (GCP), etc., to support the R & D and production of innovative drugs. The revised Measures for the administration of drug registration, the measures for the supervision and administration of drug production, the norms for the quality management of drug clinical trials and the registration classification and application materials of biological products have come into force one after another, and the links of new drug R & D, registration process, clinical trial management and production management have been reformed. In May 2021, the implementation opinions on Comprehensively Strengthening the capacity-building of drug supervision was issued, requiring to improve and improve the evaluation mechanism of innovative drugs. In June 2021, the newly revised Patent Law of the people's Republic of China came into force, in which the patent term compensation was given to the invention patents related to new drugs licensed for listing in China. In November 2021, CDE issued the guiding principles for clinical research and development of anti-tumor drugs guided by clinical value, which made guidance and requirements for the clinical research and development of anti-tumor drugs, and required pharmaceutical enterprises to implement the research and development concept of clinical value oriented and patient-centered. The above series of policies have promoted the R & D, marketing, production and sales of innovative drugs.
(III) the issuance of shares to specific objects meets the company's medium and long-term strategic development needs
The fund-raising investment projects involved in the issuance of shares to specific objects will help promote the clinical and preclinical research of the company's new drug R & D pipeline project and promote the listing process of relevant products outside China, help the company optimize the construction scheme of R & D and production center, enhance its own innovation, R & D and industrialization ability, and further improve the company's core competitiveness and the realization of the company's core development strategy, Promote the sustainable and healthy development of the company's business.
2、 The necessity of this issuance of securities and its variety selection
(I) type and par value of issued shares
The type of shares issued to specific objects this time is RMB ordinary shares (A shares) listed in China, with a par value of RMB 1.00 per share.
(II) necessity of this issuance of securities
1. Accelerate the R & D Progress of the company's new drug R & D pipeline and enhance the company's R & D and innovation ability
The company focuses on many treatment fields such as tumor, bleeding and blood diseases, hepatobiliary diseases and immune inflammatory diseases. In order to further enrich the company's product pipeline, the company continues to promote new product or indication research projects. As of the date of announcement of this demonstration and analysis report, one product of the company has been approved for the first-line treatment of advanced liver cancer; 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 initial public offering of shares; Gensun, a subsidiary of the company, is committed to discovering and developing bispecific and Trispecific tumor therapeutic antibodies, and its product line includes more than 10 research projects.
The R & D promotion of the above research projects requires further investment to accelerate the progress of innovative drug target verification and development, pharmaceutical research, preclinical research, registration application and clinical research and trial, so as to further enhance the core competitiveness of the company.
2. Upgrade the pilot workshop and commercial production sites and facilities for biological drug research and development to promote the sustainable development of the company. The development and commercialization of innovative drugs are highly competitive. The speed and effect of R & D technical strength and industrialization of achievements will become key factors. The phase II construction project of the company's new drug R & D and production center is under construction. On this basis, the company plans to further optimize the construction of the R & D and production center, further expand the area of the pilot workshop for biological drug R & D, improve the R & D conditions, attract high-level technical talents in the industry, and strengthen the R & D of innovative drugs, so as to lay the foundation for the company's new drug reserve; At the same time, the company plans to further build and optimize new drug production facilities to promote the expansion of production scale of recombinant human thrombin for external use, so as to meet the rapidly growing market demand in China and the world, and lay a good foundation for the commercialization of follow-up products.
In conclusion, it is necessary for the company to raise funds by issuing shares to specific objects this time.
3、 Appropriateness of the selection scope, quantity and standard of the issuing object
(I) appropriateness of the selection scope of the issuing object
The objects of this issuance are no more than 35 (including this number) specific investors such as securities investment fund management companies, securities companies, trust and investment companies, financial companies, insurance institutional investors, qualified foreign institutional investors (QFII), other domestic legal person investors and natural persons who meet the conditions specified by the CSRC. Securities investment fund management companies, securities companies, qualified foreign institutional investors and RMB qualified foreign institutional investors who subscribe for more than two products under their management shall be regarded as one issuance object; If a trust and investment company is the issuing object, it can only subscribe with its own funds.
After being approved by the board of directors (authorized by the board of directors of the company) and the underwriter in Shanghai Stock Exchange, the final object of inquiry will be determined by the issuer and its authorized underwriter according to the examination and approval of the board of directors of the company. If laws, regulations or normative documents have other provisions on the issuing object at the time of issuance, such provisions shall prevail.
All the issuers of this offering subscribe for the shares of the company in RMB cash at the same price.
The selection scope of this issuance object complies with the relevant provisions of laws and regulations such as the measures for the administration of registration, and the selection scope of issuance object is appropriate.
(II) appropriateness of the number of objects of this issuance
The number of issuing objects of this issuance shall not exceed 35 (including this number). The number of issuing objects shall comply with the provisions of registration management measures and other relevant laws and regulations, and the number of issuing objects shall be appropriate.
(III) appropriateness of the standards for the objects of this issuance
The issuing object should have certain risk identification ability and risk bearing ability, and have corresponding capital strength. The standards of the objects of this issuance comply with the relevant provisions of laws and regulations such as the measures for the administration of registration, and the standards of the objects of this issuance are appropriate.
4、 Rationality of the pricing principles, basis, methods and procedures of this offering
(I) pricing principle and basis of this offering
This issuance adopts inquiry issuance, and the pricing benchmark date of this issuance is the first day of the issuance period.
The issuing price of this offering shall not be lower than 80% of the average trading price of the company's shares 20 trading days before the pricing benchmark date. The final issue price of this offering will be determined by the board of directors and its authorized persons through consultation with the sponsor (lead underwriter) according to the inquiry results in accordance with the authorization of the general meeting of shareholders in accordance with the provisions of relevant laws and regulations and the requirements of the regulatory authorities after the application for this offering obtains the registration document of the CSRC, but not lower than the above-mentioned issue reserve price.
The calculation formula of the company's average stock trading price in the 20 trading days before the pricing benchmark date is: the average stock trading price in the 20 trading days before the pricing benchmark date = the total stock trading volume in the 20 trading days before the pricing benchmark date / the total stock trading volume in the 20 trading days before the pricing benchmark date. If the share price of the company's shares is adjusted due to ex right and ex interest matters such as dividend distribution, share distribution, allotment of shares, conversion of capital reserve into share capital within 20 trading days, the trading price on the trading day before the adjustment shall be calculated according to the price after corresponding ex right and ex interest adjustment.
During the period from the pricing base date to the issuance date, if the company has ex dividend and ex right matters such as dividend distribution, bonus shares or conversion of provident fund into share capital, the issuance reserve price of this issuance will be adjusted accordingly. The adjustment method is as follows:
Cash dividend: P1 = p0-d
Bonus shares or converted into share capital: P1 = P0 / (1 + n)
Cash distribution and bonus shares or share capital conversion: P1 = (p0-d) / (1 + n)
Among them, P0 is the issuance reserve price before adjustment, D is the cash dividend distributed per share, n is the number of bonus shares or converted into share capital per share, and the issuance reserve price after adjustment is P1.
(II) the pricing method and procedure of this offering are reasonable
The pricing methods and procedures of this offering are in accordance with the relevant provisions of the registration management measures and other laws and regulations. The company held the board of directors and the general meeting of shareholders for deliberation, and disclosed the relevant announcements on the website of the exchange and the information disclosure media designated by the CSRC.
The pricing method and procedure of this offering comply with the relevant provisions of laws and regulations such as the registration management measures, and the pricing method and procedure of this offering are reasonable.
To sum up, the pricing principles, basis, methods and procedures of this offering comply with the requirements of relevant laws and regulations, and the compliance is reasonable.
5、 Feasibility of this offering
(I) this issuance meets the issuance conditions stipulated in the securities law
The company has not adopted the methods of advertising, public persuasion and disguised disclosure in this offering, which is in line with the provisions of paragraph 3 of Article 9 of the securities law.
(II) the issuance plan complies with the relevant provisions of the registration management measures
The company does not violate Article 11 of the registration management measures:
"(I) arbitrarily changing the purpose of the previously raised funds without correction, or without the approval of the general meeting of shareholders;
(II) the preparation and disclosure of the financial statements for the most recent year do not comply with the accounting standards for business enterprises or relevant information disclosure rules in major aspects; An audit report with a negative opinion or unable to express an opinion on the financial and accounting report of the most recent year; The last year's financial and accounting report has been issued with qualified audit report, and the material adverse impact of the matters involved in the qualified opinion on the listed company has not been eliminated. Except that this issuance involves major asset restructuring;
(III) the current directors, supervisors and senior managers have been subject to administrative punishment by the CSRC in the last three years, or have been publicly condemned by the stock exchange in the last year;
(IV) the listed company and its current directors, supervisors and senior managers are being investigated by the judicial organ for suspected crimes or by the CSRC for suspected violations of laws and regulations;
(V) the controlling shareholders and actual controllers have committed major illegal acts that seriously damage the interests of listed companies or the legitimate rights and interests of investors in the past three years;
(VI) major illegal acts that have seriously damaged the legitimate rights and interests of investors or social and public interests in the past three years. "
In addition, the use of the company's raised funds complies with the relevant provisions of Article 12 of the registration management measures:
"(I) businesses that should be invested in the field of scientific and technological innovation;
(II) comply with national industrial policies and laws and administrative regulations on environmental protection and land management;
(III) after the implementation of the fund-raising project, it will not have a significant adverse impact on the increase of controlling shareholders, actual controllers and other enterprises under their control
