After this stock issuance, it is planned to be listed on the science and innovation board market, which has high investment risk. Kechuang board company has the characteristics of large R & D investment, high operation risk, unstable performance and high delisting risk, and investors are facing great market risk. Investors should fully understand the investment risks of the science and innovation board market and the risk factors disclosed by the company, and make investment decisions prudently.
Maiwei (Shanghai) Biotechnology Co., Ltd
Mabwell (Shanghai) Bioscience Co., Ltd.
(room 105, building 2, No. 230 Cailun Road, China (Shanghai) pilot Free Trade Zone)
Initial public offering and listing on the science and Innovation Board
Letter of intent
Sponsor (lead underwriter)
No. 689, Guangdong Road, Shanghai
December, 2001
Issuer statement
Any decision or opinion made by the CSRC and the exchange on this issuance does not indicate that they guarantee the authenticity, accuracy and integrity of the registration application documents and the information disclosed, nor do they indicate that they make substantive judgment or guarantee on the profitability, investment value of the issuer or the income of investors. Any statement to the contrary is a false statement.
According to the provisions of the securities law, the issuer shall be responsible for the changes in the operation and income of the issuer after the shares are issued according to law; Investors independently judge the investment value of the issuer, make investment decisions independently, and bear the investment risks caused by changes in the operation and income of the issuer or changes in the stock price after the shares are issued according to law.
The issuer and all directors, supervisors and senior managers promise that the prospectus and other information disclosure materials are free from false records, misleading statements or major omissions, and bear individual and joint legal liabilities for their authenticity, accuracy and completeness.
The controlling shareholder and actual controller of the issuer promise that there are no false records, misleading statements or major omissions in this prospectus, and bear individual and joint legal liabilities for its authenticity, accuracy and completeness.
The person in charge of the company, the person in charge of accounting and the person in charge of accounting institutions shall ensure that the financial and accounting materials in the prospectus are true and complete.
The issuer and all directors, supervisors, senior managers, the controlling shareholders and actual controllers of the issuer, as well as the sponsors and underwriting securities companies promise to compensate investors for losses in securities issuance and trading due to false records, misleading statements or major omissions in the issuer’s prospectus and other information disclosure materials.
The sponsor and the securities service institution promise to compensate the investors for the losses caused to the investors due to the false records, misleading statements or major omissions in the documents prepared and issued for the issuer’s public offering.
Overview of this offering
1、 Type of shares issued: RMB ordinary shares (A shares)
The number of shares issued by the issuer this time is 99.9 million, which does not involve shareholders. II. The number of shares issued and the number of shares offered to the public account for 25.00% of the total share capital after this issuance
3、 The par value of each share is RMB 1.00
4、 Issue price per share [*] yuan / share
5、 Expected issue date: January 4, 2022
6、 Stock exchanges and plates to be listed Shanghai Stock Exchange science and Innovation Board
7、 The total share capital after issuance is 399.6 million shares
8、 Sponsor (lead underwriter) Haitong Securities Company Limited(600837)
9、 Signing date of the prospectus: December 24, 2021
Tips on major events
The issuer reminds investors to pay special attention to the following matters and risks of the company’s issuance, and carefully read the text of the prospectus. 1、 The issuer is a biomedical industry company adopting the fifth set of listing standards
The issuer is a biomedical industry company adopting the fifth set of listing standards. The issuer reminds investors to pay attention to the following characteristics and risks of the company:
(i) No products are sold on the market, resulting in the company’s non-profit and continuous loss
As of the signing date of this offering intention, all varieties of the company are in the R & D stage, have not carried out commercial production and sales, and have not realized sales revenue of drugs. The company has not made profits and has accumulated outstanding losses: December 31, 2018, December 31, 2019, December 31, 2020 and June 30, 2021, The company’s accumulated outstanding losses were 400.6468 million yuan, 132.854088 million yuan, 97.30955 million yuan and 131.24856 million yuan respectively. In the future, the company is expected to continue to make losses, and the accumulated outstanding losses will continue to expand.
（2） It is expected that large-scale R & D investment will continue in the future
During the reporting period, the company invested a lot of money in preclinical research, clinical trials and preparation for new drugs. In 2018, 2019, 2020 and January June 2021, the company’s R & D expenses were 169071900 yuan, 363044800 yuan, 581329700 yuan and 261929800 yuan respectively. As of the signing date of this offering intention, the company’s product pipeline has 15 varieties under research, and its development businesses such as preclinical research, clinical trial and preparation for new drugs before listing still need to continue large-scale R & D investment.
（3） There is uncertainty in the listing of main varieties under research
Due to the uncertainty of whether the research data at each stage meet the review and approval requirements (whether the review and approval requirements change or not) in the new drug R & D and marketing application stage, the company can not guarantee that the research data obtained from the varieties under research can meet the review and approval requirements, so as to ensure that the new drugs developed can be approved by the regulatory authority for marketing.
（4） Failure to make profits may result in termination of listing
The company will continue to invest in large-scale R & D in the next few years, and the corresponding varieties of the company’s R & D expenditure will be treated as expenses before obtaining the approval for the listing of new drugs. Therefore, the unprofitable state after listing is expected to continue, and the accumulated outstanding losses may continue to expand. If the company triggers article 12.4 of the Listing Rules of Shanghai Stock Exchange on the science and innovation board in the fourth full fiscal year from the date of listing The financial position specified in Article 2, That is, the audited net profit (including retroactive restatement) before or after deducting non recurring profits and losses is negative, and the operating income (including retroactive restatement) is less than RMB 100 million, or the audited net assets (including retroactive restatement) is negative, which will cause the company to trigger delisting conditions. If the company’s main product research and development fails or fails to obtain drug listing approval after listing, and the company has no other business or products meet the requirements of item 5 of article 2.1.2 of the Listing Rules of science and innovation board of Shanghai Stock Exchange, it will also cause the company to trigger delisting conditions. According to In the measures for continuous supervision of listed companies on the science and Innovation Board (for Trial Implementation), if the company touches the criteria for termination of listing, the listing of shares shall be terminated directly, and the procedures for suspension, resumption and re listing shall no longer apply. II. Progress of the issuer’s main product pipeline, market competition and corresponding risks
(i) Progress of product pipeline
As of the signing date of this offering intention, the issuer has 15 varieties under research covering the fields of autoimmunity, tumor, metabolism, ophthalmology, infection and other diseases. 9mw0113 developed in cooperation with Shanghai Junshi Biosciences Co.Ltd(688180) has applied for the listing of new drugs in November 2019; The application for drug marketing license of varieties 9mw0311 and 9mw0321 independently developed by the issuer has been accepted in December 2021; Another 3 varieties under development are in the key registration clinical trial stage, of which 9mw0813 is in the phase III clinical trial stage, 8mw0511 and 9mw0211 are in the phase II / III clinical trial stage; One variety 9mw3311 is in phase II clinical trial stage; The other 8 varieties under research are in phase I clinical trial stage, clinical implied license stage or preclinical research stage.
（2） Market competition of main varieties under research
The company has applied for the listing of new drugs and is in the key registration clinical trial stage and phase II clinical trial stage. The varieties under research and their market competition are as follows:
Market competition 1
Drug name target indication R & D progress phase II / III phase I listed NDA clinical
9mw01132 rheumatoid arthritis and other nda5263
9mw03113 fracture high risk female postmenopausal nda1326 osteoporosis
9mw03214 prevention of nda1225 bone related events in patients with solid tumor bone metastasis
8mw05115 prevents neutropenia in phase II / III clinical 3051 caused by tumor chemotherapy
9mw02116 neovascularization (wet) phase II / III clinical 3096 macular degeneration
Market competition 1
Drug name target indication R & D progress phase II / III phase I listed NDA clinical
9MW33117 treatment of New Coronavirus infection II phase clinical 10114
9MW08138 III stage of diabetic macular edema 1030
Note 1: the competition situation includes the issuer’s varieties;
Note 2: the market competition of 9mw0113 in China is adalimumab (xiumeile) ®） And its biological analogues; Note 3: the market competition of 9mw0311 in China is desuzumab (prolix) ®） And the competition of the same or similar drugs; Note 4: the market competition of 9mw0321 in China is desuzumab (angavir) ®） And the competition of the same or similar drugs; Note 5: 8mw0511 China’s market competition is the competition of long-term G-CSF products;
Note 6: 9mw0211 is an innovative drug, and its statistical scope of market competition in China covers all therapeutic biological products with indications of neovascular (wet) macular degeneration;
Note 7: 9mw3311 is an innovative drug, and its competition is global competition. Two of the varieties in phase II / III clinical trials in the table have obtained emergency use authorization (EUA) in the United States;
Note 8: the market competition of 9mw0813 in China is arbasip (aliya) ®） And its biological analogues.
Source: frost Sullivan analysis, announcement of listed companies, statistical deadline: December 21, 2021
（3） Risks of 9mw0113, 9mw0311 and 9mw0321
As of the signing date of this offering intention, the new drug listing application of 9mw0113 jointly developed by the company and Shanghai Junshi Biosciences Co.Ltd(688180) has been accepted and is expected to be approved in the first quarter of 2022; The drug marketing license application of the company’s independently developed varieties 9mw0311 and 9mw0321 has been accepted in December 2021, and 9mw0311 and 9mw0321 are expected to be approved in 2023. If 9mw0113, 9mw0311 and 9mw0321 fail to pass the listing approval, the company will not generate drug sales revenue before 2023, which will have an adverse impact on the company’s business, financial status, operating performance and prospects.
9mw0113, 9mw0311 and 9mw0321 are biological analogues, and there is a risk that the commercial value will be reduced due to the failure to obtain the extrapolation of indications. After 9mw0113, 9mw0311 and 9mw0321 were approved for listing as scheduled, the market competition was fierce, and they were faced with the price pressure brought by the centralized procurement of biological similar drugs, resulting in 9mw0113 and 9mw
