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 issuer, and make investment decisions prudently.
Jiangsu Yahong Pharmaceutical Technology Co., Ltd
Jiangsu Yahong Meditech Co., Ltd.
(room 1009, building D, phase II, new drug creation base, No. 1 Yaocheng Avenue, Taizhou (east of Chuangye road and north of Yuannan Road)
Prospectus for initial public offering and listing on the science and Innovation Board
Sponsor (lead underwriter)
(North block, excellence Times Plaza (phase II), No. 8, Zhongxin Third Road, Futian District, Shenzhen, Guangdong)
Statement and commitment
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 there are no false records, misleading statements or major omissions in the prospectus and other information disclosure materials, 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 agency 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.
Overview of this offering
Type of shares issued: RMB ordinary shares (A shares)
Number of shares issued: the number of shares issued by the company this time is 110 million, accounting for 19.30% of the share capital after issuance; The original shareholders of this offering will not offer shares to the public
Par value per share: RMB 1.00
Issue price per share: RMB 22.98
Expected issue date: December 27, 2021
Listed stock exchanges and sectors: Scientific Innovation Board of Shanghai Stock Exchange
Total share capital after issuance: 570 million shares
Sponsor (lead underwriter): Citic Securities Company Limited(600030)
Signing date of prospectus: December 31, 2021
Tips on major events
The company specially reminds investors to pay attention to the following major matters and risks, and carefully read the full text of the chapter “risk factors”. 1、 The issuer is a biomedical industry company adopting the fifth set of listing standards
The issuer is a global innovative drug company focusing on the field of urogenital system tumors and other major diseases. At present, the issuer has no products on the market. As of the signing date of this prospectus, the issuer is carrying out 12 research projects corresponding to 9 main products, of which 3 studies corresponding to 2 products have been in phase III or key clinical trials.
The issuer shall apply and comply with the listing standards specified in Item (5) of paragraph 2 of Article 22 of the examination rules for the issuance and listing of shares on the science and Innovation Board of Shanghai Stock Exchange: “The market value is expected to be no less than RMB 4 billion, the main business or products need to be approved by relevant state departments, the market space is large, and phased results have been achieved. Pharmaceutical enterprises need to have at least one core product approved to carry out phase II clinical trial, and other enterprises that meet the positioning of the science and innovation board need to have obvious technical advantages and meet corresponding conditions”. As an innovative drug R & D 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) the risk that the clinical trial progress of the issuer’s drug under development is less than expected
The progress of new drug R & D and clinical trials is affected by multiple factors. With the advancement of the R & D process of each research project, the issuer expects that multiple product indications will enter the clinical trial stage in the next three years. When recruiting patients and determining clinical trial institutions, the issuer may encounter difficulties due to factors such as the number of enrolled patients, defining qualification standards, competitors carrying out similar clinical trials in the same period, thus hindering the completion of clinical trials on schedule. The issuer may encounter a variety of unforeseen events during the progress of clinical trials, which may delay the clinical progress and hinder the products under development from obtaining regulatory approval. The above factors may have a significant adverse impact on the company’s business. （2） Risk that the clinical trial results of the issuer’s core products are less than expected
The new drug research and development process is long, the cost is high, and the results are highly uncertain. Industry practice shows that even if some candidate drugs make progress in preclinical research and initial clinical trials, they may not show ideal safety and efficacy in the later stage of clinical trials due to a variety of reasons, and even directly lead to project failure. The issuer cannot guarantee that any preclinical study and early clinical trial data can predict the subsequent clinical results of candidate drugs. If the company’s core product fails to obtain good clinical data and has to give up the follow-up R & D work, the company’s early R & D investment in the product will not be recovered, and the issuer’s future profitability will also be significantly and adversely affected.
1、APL-1202
(1) Apl-1202 risk of clinical failure
As of the signing date of this prospectus, two key / phase III clinical trials of apl-1202 in China are in progress, and the issuer has not obtained the results of the clinical trial. The issuer cannot guarantee that the preclinical research and early clinical trial data of apl-1202 can predict the subsequent clinical results. If the critical / phase III clinical trial of apl-1202 fails to obtain significant results and has to give up the follow-up R & D work, the issuer’s early R & D investment in the product will not be recovered, and the issuer’s future profitability will also be significantly and adversely affected.
(2) Patent risk of apl-1202
At present, there are no methap2 inhibitors approved for marketing worldwide, and most of them are in the early stage of clinical research and development. APL-1202 is a reversible MetAP2 inhibitor. The publisher has promoted it to the two critical phase /III clinical trials of non muscle invasive bladder cancer (NMIBC), but there is still uncertainty in subsequent research and development. Since there is no MetAP2 targeted drug on the market at present, the target drug of MetAP2 is uncertain, and apl-1202 has the risk of final non drug.
2. Apl-1702 clinical development is less than expected risk
As of the signing date of this prospectus, the global multicenter phase III clinical trial of apl-1702 is in progress, and the issuer cannot guarantee that apl-1702 can achieve the expected objectives on the subjects according to the established trial scheme. If the phase III clinical trial of apl-1702 fails to obtain significant results and has to give up the follow-up R & D work, the issuer’s early R & D investment in the product will not be recovered, and the issuer’s future profitability will also be significantly and adversely affected. （3） It still takes some time for the issuer’s core drug under research to submit the listing application, and there is uncertainty in the approval of listing
As of the signing date of this prospectus, the three studies corresponding to the issuer’s core products apl-1202 and apl-1702 are in the stage of critical or phase III clinical trials. Due to the uncertainty of follow-up clinical trials and new drug review and approval, the issuer still needs some time to submit the new drug listing application, and the approval of the regulatory authority is still required before listing. If the follow-up clinical trial and approval time of the drug under development of the issuer are greatly delayed than expected by the issuer, the drug under development cannot obtain the new drug marketing approval, or such approval contains significant restrictions, it will have a significant adverse impact on the business operation of the issuer. （4） The issuer’s core products have not yet been listed for sale, and there is uncertainty in the market space after the products are listed
As of the signing date of this prospectus, the issuer’s core products apl-1202 and apl-1702 are in phase III or key clinical trials, and the first indication is expected to be listed in 2023 and 2024 respectively. The issuer has no experience in commercial sales of products. If the marketing work of the company’s sales team fails to meet expectations after the listing of apl-1202 and apl-1702, and apl-1202 and apl-1702 are not recognized by doctors and patients, it will have an adverse impact on the improvement of apl-1202 and apl-1702 market penetration. Meanwhile, if apl-1202 and apl-1702 are not included in the medical insurance directory and medication guide for a long time after being approved for listing, or are transferred out after being included in the medical insurance directory and medication guide, the sales of apl-1202 and apl-1702 may not increase rapidly or decline, thus affecting the market space after the product is listed. （5） The issuer cannot guarantee to make profits in the next few years, and the company may also face delisting risk after listing. The issuer will continue to invest in large-scale R & D in the next few years, and the R & D expenses will continue to be at a high level. The unprofitable state after listing is expected to continue, and the accumulated uncovered losses may continue to expand in the short term. If the R & D and listing process of the issuer’s core products apl-1202 and apl-1702 are delayed to a large extent or cannot be approved for listing, and the commercialization progress after being approved for listing does not meet the expectations, the financial status in article 12.4.2 of the Listing Rules of Shanghai stock exchange for shares on the science and Innovation Board will be triggered in the fourth full fiscal year from the date of listing, That is, if 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 RMB 100 million, or the audited ending net assets (including retroactive restatement) are negative, the issuer may trigger delisting conditions. 2、 Product pipeline progress, market competition and corresponding risks (I) product pipeline progress
As of the signing date of this prospectus, the issuer is developing 9 products, of which 3 studies of 2 innovative products have been in phase III or key clinical trials.
The APL-1202 project has two indications in the field of non muscle invasive bladder cancer (NMIBC) in China: phase I is entering critical or III phase clinical trials: (1) concurrent chemotherapy followed by second-line treatment for recurrent
High risk NMIBC; (2) Single drug first-line treatment of untreated moderate risk NMIBC. Apl-1202 combined chemotherapy
The indications of moderate and high-risk NMIBC for second-line perfusion treatment of recurrence are expected to be submitted to the State Food and Drug Administration in 2022
City application. In the field of myometrial invasive bladder cancer (MIBC), the issuer obtained the United States in June 2021.
FDA approval for phase I / II clinical trial of apl-1202 combined with tirelizumab in the treatment of MIBC,
At present, it is preparing to start clinical enrollment in the United States and obtain the approval of China CDE ind at the end of September 2021.
Apl-1702 is a photodynamic therapy product integrating drugs and devices, which is mainly used for the treatment of all kinds of diseases
There are high-grade squamous intraepithelial lesions (HSIL) of the cervix caused by HPV virus subtype infection
Cervical precancerous lesions). Apl-1702 is in the stage of international multicenter phase III clinical trial, and the issuer expects
It will take the lead in submitting the listing application of apl-1702 in China in the fourth quarter of 2022.
（2） Market competition of main products and corresponding risks
1. Apl-1202 China’s NMIBC field will face the risk of fierce market competition in the future
As of June 30, 2021, no targeted drugs for NMIBC had been approved for marketing in China, with 7
Three innovative drugs are in the clinical stage, including 3 oral drugs, 2 bladder perfusion drugs and 2
Three are injectable drugs targeting PD-1. The specific products under development are as follows:
NMIBC products under development in China
Drug code / company action, indication, clinical stage, combination, number of treatment lines, type, common name, target mode
Untreated
