Special note: 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.
Nuocheng Jianhua Pharmaceutical Co., Ltd
InnoCare Pharma Limited
（Ogier Global (Cayman) Limited, 89 Nexus Way, Camana Bay,
Grand Cayman, KY1-9009, Cayman Islands）
Prospectus for initial public offering of RMB common shares (A shares) and listing on the science and Innovation Board
(last draft)
Statement: the issuance application of the company still needs to go through the corresponding procedures of Shanghai Stock Exchange and China Securities Regulatory Commission. This Prospectus has no legal effect on the issuance of shares and is only for pre disclosure. Investors shall take the officially announced prospectus as the basis for investment decisions.
Sponsor (lead underwriter)
(27th and 28th floors, building 2, international trade building, No. 1 Jianguomenwai street, 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.
Statement and commitment
The issuer and all directors 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 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, senior managers, 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)
The number of RMB shares issued this time (excluding the number of shares issued with over allotment option) does not exceed 264650000 shares, accounting for 15% of the sum of the number of shares issued by the company on March 31, 2021, the total number of issued shares and the number of RMB shares to be issued and placed according to this issuance. On the premise of complying with Chinese laws and regulations, the over allotment option may be granted for RMB shares not exceeding 15% of the number of initially issued shares
Par value of US $1 China Vanke Co.Ltd(000002) per share
The issue price per share is RMB []
Expected issue date: mm / DD / yyyy
Stock exchanges and sectors to be listed Shanghai Stock Exchange science and Innovation Board
The total number of issued shares after issuance shall not exceed 1764323235 shares 2 (before exercising the over allotment option)
Sponsor (lead underwriter) China International Capital Corporation Limited(601995)
Signing date of prospectus: mm / DD / yyyy
1. The A-share shares issued by the company this time will be registered and deposited in the Shanghai Branch of zhongdeng company, and the registration, deposit and settlement related businesses will be handled in accordance with the registration and settlement rules of zhongdeng company and the provisions of Chinese laws and regulations. Since the par value of the shares issued by the company this time is US $0 China Vanke Co.Ltd(000002) , the company intends to convert the par value of the shares into the corresponding RMB amount according to the central rate of RMB Exchange announced by the people's Bank of China on the announcement date of the prospectus related to this issue at that time (if the central rate of RMB exchange is not announced by the people's Bank of China on that date, it will be postponed to the central rate of RMB Exchange announced on the next announcement date), The converted par value is only used for the share registration of zhongdeng company.
2. The total number of shares before and after this issuance is calculated on the basis of the total number of issued shares of 1499673235 shares on March 31, 2021.
Tips on major issues
The company reminds investors to carefully read the full text of this prospectus and pay special attention to the following important matters. 1、 The company is a biotechnology company that has not yet made a profit and has accumulated outstanding losses
The company is an innovative biomedical enterprise with excellent independent R & D capability as the core driving force. As of the signing date of this prospectus, one of the company's main products, albutinib (enokai) ®） It has been approved by the State Food and Drug Administration in December 2020. 3, 9 products are in phase I / II / III clinical trial stage, and 6 products are in preclinical stage. R & D, production and commercialization of new drugs are a process with large investment, long cycle and high risk. The company continues to invest in drug discovery, clinical development, production, commercialization and other links. During the reporting period, the company has not made a profit and has accumulated outstanding losses. The company reminds investors to pay attention to the following characteristics and risks of the company: (I) the company has not made a profit and has accumulated outstanding losses
The research and development of new drugs is highly uncertain, requires a lot of early-stage capital expenditure, and there is a huge risk that the products under research will not obtain regulatory approval or have no commercial feasibility.
As of the signing date of this prospectus, one of the company's main products, albutinib (enokai) ®） Commercial sales have begun. In addition, other products of the company are in the research and development stage, and the company has not made a profit and has accumulated outstanding losses. In 2019, 2020 and 2021, the net profits attributable to the shareholders of the parent company were -214138 million yuan, - 39.139 million yuan and -64.546 million yuan respectively. As of December 31, 2021, the company's accumulated outstanding loss balance was 35616648 million yuan. For some time to come, the company expects to have accumulated outstanding losses and will continue to suffer losses. (II) the company has many product pipelines, and it is expected that large-scale R & D investment will be required in the future
During the reporting period, the company invested a lot of money in preclinical research, clinical trials and new drug pre marketing preparation of product pipelines. The amount of R & D expenses in 2019, 2020 and 2021 are 234173 million yuan, 42.336 million yuan and 732714 million yuan respectively. As of the signing date of this prospectus, the company has 1 product on the market, 9 products are in phase I / II / III clinical trial stage and 6 products are in preclinical stage. In the future, the company still needs to continue large-scale R & D investment to complete preclinical research, clinical trials and preparations for new drugs before listing, which is expected to continue to generate large-scale R & D expenses. 3 full approval will depend on the results of ongoing confirmatory clinical trials.
(III) the company's clinical trial results may not be as expected
In the process of new drug research and development, although the products under research show good preclinical experimental data or early clinical trial data, they may have poor safety or effectiveness in later clinical trials due to a variety of reasons. Good preclinical experimental data or early clinical trial data can not predict the success of later clinical trials, and the interim results of clinical trials can not predict the final results. If the clinical test results of the products under development are less than expected, the company may not be able to obtain the drug registration certificate, which will have an adverse impact on the company's business. (IV) the company's products under development may not be able to obtain regulatory approval or the registration and approval process may be delayed
The R & D cycle of innovative drugs is long and the registration process is complex. In this process, the drug registration evaluation system may change or the regulatory authorities may improve relevant standards, resulting in the progress or results of innovative drug registration and approval less than expected. The company's products under development may be unable to obtain regulatory approval or the approval process may be delayed due to various reasons, including but not limited to: (1) failing to start or complete clinical trials without obtaining the approval of regulatory authorities; (2) Failing to prove that the product under development has good safety and effectiveness, or the clinical test results do not meet the statistical significance level required by the approval; (3) Regulators do not agree with the company's interpretation of preclinical trial data or clinical trial data; (4) The change of registration review policy leads to insufficient preclinical trial data or clinical trial data of the company, or requires the company to revise the clinical trial plan; (5) The company fails to conduct clinical trials in accordance with regulatory provisions or established clinical trial plans; (6) The clinical trial site, researchers or other participants in the clinical trial deviate from the trial scheme, fail to conduct the trial or withdraw from the trial in accordance with the regulations, etc. The above reasons may cause the progress or results of innovative drug registration and approval to be less than expected, resulting in an adverse impact on the company's business. (V) the company's products under development may not be recognized by the market
The market recognition of the company's products under research is affected by many factors, such as the competitive advantage of the products under research compared with other alternative therapies, treatment cost, market promotion effect and so on. After the company's products under development are approved for listing, they may not be recognized by doctors, patients, payers and other relevant parties, so they cannot generate considerable sales revenue. Even if the company's products under research are recognized by the market after being approved for listing, the advent of new products with more advantages than the company's products under research may make the company's products under research unable to maintain market recognition. (VI) the confirmatory clinical trial after conditional approval may not meet the relevant requirements of full approval
As of the signing date of this prospectus, one of the company's main products, albutinib (enokai) ®） It has been conditionally approved by the State Food and drug administration to be listed for the treatment of recurrent or refractory MCL and recurrent or refractory CLL / SLL. According to the drug registration certificate of orbutinib, the company needs to complete the phase III confirmatory clinical trial after the listing of orbutinib. After the completion of the above confirmatory clinical trials, obetinib can be fully approved. The research and development of innovative drugs is affected by many factors such as patient enrollment and policy changes. There is a certain uncertainty whether the clinical trial can be completed on schedule. If the company cannot meet the relevant requirements put forward by the State Food and drug administration when approving the listing of orbutinib with conditions, there may be risks such as failing to apply for drug re registration after the expiration of the validity period of the drug approval number, and the drug regulatory authority revoking the conditional listing license. 2、 Main business, product pipeline progress and market competition of the company (I) basic business information of the company
The company is an innovative biomedical enterprise with excellent independent R & D capability as the core driving force. It has comprehensive R & D and commercialization capabilities, focuses on the fields with huge unmet clinical needs such as tumors and autoimmune diseases, and develops the best or first-of-a-kind drugs with breakthrough potential in the global market.
Under the leadership of the management team with rich experience in R & D, production and commercialization, the company has built an integrated biomedical platform, taking into account the needs of R & D quality and R & D speed, and established a product pipeline with a high balance of innovation and risk and covering multiple hot targets with great market prospects, It is accelerating its growth as a biomedical leader in developing and providing innovative therapies for patients with tumors and autoimmune diseases around the world. (II) progress of product pipeline
As of the signing date of this prospectus, one of the company's main products, albutinib (enokai) ®） The product was approved by the National Drug Administration in September 2020 and was in phase I / II clinical trial conditions, and the product was in phase I / II clinical trial conditions before June 2020. The main research projects of the company are shown in the table below:
clinical
Field product name: progress of target indication test
develop
region
Recurrent or refractory CLL / SLL has been conditionally approved in China
