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. Investors are facing greater 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.
Shouyao Holdings (Beijing) Co., Ltd
(address: 2205, floor 22, block a, building 1, No. 10, Ronghua Middle Road, Beijing Economic and Technological Development Zone) letter of intent for IPO and listing on the science and Innovation Board
Sponsor (lead underwriter)
(address: Building 4, No. 66 Anli Road, Chaoyang District, Beijing)
Any decision or opinion made by the CSRC and the exchange on this issuance does not indicate that they guarantee the authenticity, accuracy and completeness 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 the changes in the operation and income of the issuer or the changes in the stock price after the shares are issued according to law.
Issue overview
Type of shares issued: RMB ordinary shares (A shares)
The number of shares in this public offering is 37.18 million, accounting for 25.00% of the total share capital after the issuance. The shares issued this time are all new shares issued to the public, not involving the public offering of shares by the original shareholders
The sponsor will arrange China Securities Co.Ltd(601066) Investment Co., Ltd., an alternative investment subsidiary established according to law, to participate in the strategic placement of this offering. The initial expected follow-up investment ratio is 5.00% of the shares issued to the public, that is, 1859000 shares, Finally, the specific example and amount of the sponsor's relevant subsidiaries participating in the strategic allocation will be determined after the issuance price and sales situation are determined on March 10, 2022 (T-2). The difference between the final placement quantity and the initial placement quantity of strategic investors is first transferred back to offline issuance. The restricted period of the shares allocated to this follow-up investment is 24 months, which shall be calculated from the date of listing of the shares issued to the public
Non participation of senior managers and employees of the issuer in strategic placement and strategic placement
The par value of each share is RMB 1.00
The issue price per share is RMB []
Expected issue date: March 14, 2022
The stock exchange and the scientific innovation board of Shanghai Stock Exchange to be applied for listing
The total share capital after issuance is 148719343 shares
Sponsor (lead underwriter) China Securities Co.Ltd(601066)
Signing date of the prospectus: March 4, 2022
Statement and commitment
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 the accounting institution shall ensure that the financial and accounting materials in the prospectus are true and complete.
The issuer and all directors, supervisors, senior managers, controlling shareholders, actual controllers, 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.
Tips on major issues
The company specially reminds investors to pay full attention to the following major issues and carefully read the "risk factors" section of this prospectus:
1、 The company is an R & D enterprise applicable to the fifth set of listing standards. Its products are in the R & D stage. At present, there is no drug approved for marketing, and there is uncertainty in R & D
The company is an innovative drug research and development enterprise applicable to the fifth set of listing standards. Its products are in the research and development stage. At present, there are no drugs approved for marketing. As of the signing date of this offering intention, the company has 22 projects under research, all of which are class 1 new drugs, including 11 independent R & D pipelines and 11 cooperative R & D pipelines. In the independent R & D project, one product has entered phase II / III clinic, one product has entered phase II clinic and four products have entered phase I clinic. In the cooperative R & D projects, one product entered phase II / III clinical, two products entered phase II clinical and eight products entered phase I clinical.
The research and development of new drugs is uncertain, especially in the aspects of target screening and compound design. Although the company has carried out structure-based drug design and ultra-high throughput virtual screening through new technology based on computer science and its simulation ability, so as to evaluate the drug formation, oral effectiveness, metabolic stability Early simulation and evaluation of blood-brain barrier, toxicity and other indicators can reduce the risk of new drug research and development in the compound design stage, but the subsequent preclinical stage and clinical stage may be unable to continue due to the poor safety or efficacy of candidate compounds.
There is great uncertainty in the clinical research and development of innovative drugs. Whether the drug clinical trial scheme can be successfully implemented and completed is affected by the approval progress of the clinical scheme, the approval progress of the genetics Office of the Ministry of science and technology, the ethical review progress of the research center, and the enrollment progress of clinical trial patients to a certain extent.
When recruiting patients for clinical trials, they will be subject to competition from pharmaceutical companies engaged in the research and development of similar products, which will reduce the number and types of patients that the company can potentially recruit. At the same time, the recruitment of clinical trial patients will also be affected by the resource competition of clinical trial suppliers, the resource competition of hospitals or clinical trial centers, and the competition of clinical related human resources.
Even if the company can recruit enough patients in the clinical trial, if the patient recruitment is delayed, it may increase the cost or affect the time or results of the clinical trial, then hinder the completion of the clinical trial and adversely affect the R & D process of the company's products under research. Therefore, there is a risk that the clinical progress of the company's products under research is less than expected.
After completing the clinical trial, the company needs to apply to CDE for drug listing. After obtaining the approval of drug registration, it can be officially listed for sale. In the process of CDE reviewing the company's drug listing application, there may be a long period for the drug to be approved for listing, or the drug cannot be approved for listing, which will have an adverse impact on the company's business operation and the time to achieve profitability.
2、 At present, the company has not generated drug sales revenue, there is a large amount of accumulated outstanding losses, and there is a risk that it will not be able to realize profit and profit distribution in the short term
At present, the company has no products on the market and has not generated drug sales revenue, and there is still great uncertainty about whether and when the products can be listed. The company cannot generate product sales revenue in a certain period in the future. In order to ensure the successful R & D and timely launch of products, the company needs to make continuous R & D investment, which may still be in a non profitable State in a certain period of time in the future. During the reporting period, the net profit of the company was -218153 million yuan, - 359857 million yuan, - 3301409 million yuan and -695931 million yuan respectively. As of the end of June 2021, the company's accumulated outstanding loss was -3710471 million yuan. In the future, the company may continue to make losses, and the accumulated amount of outstanding losses will continue to increase, resulting in the inability of the company to distribute profits, which will have an adverse impact on the company's capital status, R & D investment, business development, talent introduction and team stability.
3、 The company's products have market competition and marketing risks, and the commercialization of products after listing is less than expected
The company's core products sy-707 and sy-3505 are ALK inhibitors, which will face the market competition of ALK inhibitors. By the end of December 2023, ALK drugs had been imported, of which ALK drugs had been approved in the Chinese market; The four drugs have entered the medical insurance catalogue, and there is a possibility of further price reduction in the future; In addition to the listed products, imported ALK inhibitors bugatinib and loratinib have applied for new drug listing (NDA), which may further aggravate the market competition in the future. Sy-1530 is a Btk inhibitor for the treatment of mantle cell lymphoma. By the end of December 2021, three Btk inhibitor products for the treatment of mantle cell lymphoma in China had been listed and had entered the medical insurance catalogue. At present, many enterprises are carrying out clinical research on products under research for the same indications. In addition to the above core products, other products under research by the company may have listed or clinical competitive products with the same indications and targets. The above market competition may have an impact on the market share of the company's products, and then affect the company's operating performance and profitability. At the same time, the company has not carried out the commercial operation of products, has not established a complete sales team and system, and has no experience in commercial sales. There is uncertainty about whether it can effectively promote and realize the large-scale sales of products after the products are listed, and the company has the risk that the commercialization of products after the products are listed is not as expected.
4、 The company's core product sy-707 has the risk of revoking the listing approval after approving conditional listing
The company's core product sy-707 has been approved by CDE. It can apply for conditional approval for listing after the results of phase II clinical trial meet the expectations. The State Food and drug administration stipulates in the working procedures for the review and approval of the application for listing with conditional approval (for Trial Implementation) that for the drugs approved for listing with conditional approval, the holder of the drug listing license shall complete the relevant research such as drug clinical trials within the specified time limit after the drugs are listed, and apply in the form of supplementary application. If the post marketing research submitted by the drug marketing license holder proves that its benefits outweigh the risks, and passes the review, the drug registration certificate with a validity of 5 years shall be renewed. If the post marketing research submitted by the holder of the drug marketing license cannot prove that its benefits outweigh the risks, the drug examination center will make a negative evaluation conclusion, and the State Drug Administration will cancel its drug registration certificate according to procedures.
Therefore, if sy-707 is approved for conditional listing after the phase II clinical trial results meet the expectations, it is still necessary to continue to promote the follow-up clinical trial after listing. If the follow-up clinical trial cannot prove that the benefits of sy-707 treatment for patients outweigh the risks, there will be a risk that it will not pass the review of the drug examination center and the drug registration certificate will be cancelled by the State Food and drug administration according to the procedures.
5、 The company has the risk of touching the criteria for termination of listing after listing
The company will continue to invest in large-scale R & D in the next few years. Before the new drugs are approved for listing and sold rapidly and in large quantities, it may not be able to cover the company's early capital investment. After the company is listed, the unprofitable state of the company may persist or the accumulated uncollected losses may continue to expand.
If the fourth full fiscal year since the listing date of the company triggers the financial condition index in article 12.4.2 of the Listing Rules of science and Innovation Board of Shanghai Stock Exchange, that is, the audited net profit (including retroactive restatement) before and after deducting non recurring profits and losses is negative, the operating income (including retroactive restatement) is less than 100 million yuan, or the audited net assets (including retroactive restatement) are negative, It may cause the company to trigger delisting risk warning conditions.
If the company's main product research and development fails or fails to obtain the drug listing approval after listing, and the company has no other business or products meet the requirements of the estimated market value and financial indicators specified in Item 5 of article 2.1.2 of the Listing Rules of science and Innovation Board of Shanghai Stock Exchange, the company may also trigger the delisting risk warning conditions. If the company fails to meet the relevant conditions for withdrawing the delisting risk warning stipulated in the Listing Rules of Shanghai Stock Exchange on the science and innovation board, the company will face the risk of terminating the listing.
6、 Main financial information and operating conditions after the audit deadline of financial report
(I) main financial information after the audit deadline
The deadline for the audit of the company's financial report is June 30, 2021. Tianjian Certified Public Accountants (special general partnership) reviewed the company's consolidated and parent company's balance sheet as of December 31, 2021, consolidated and parent company's income statement, consolidated and parent company's cash flow statement and notes to financial statements in 2021, and issued the review report.
As of December 31, 2021, the total assets of the company were 58.176 million yuan, a decrease of 67.05% over the end of the previous year; Total liabilities amounted to 57.995 million yuan, an increase of 92.40% over the end of the previous year; The owner's equity attributable to the parent company is 18.10