Tips on investment risk of science and Innovation Board
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. OBIO Technology (Shanghai) Corp., Ltd
(building 19, Lane 908, Ziping Road, Xi’An International Medical Investment Company Limited(000516) Park, Pudong New Area, Shanghai)
Initial public offering and listing on the science and Innovation Board
Prospectus
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.
(No. 689, Guangdong Road, Shanghai)
Co lead underwriter
(No. 618, Shangcheng Road, China (Shanghai) pilot Free Trade Zone)
Important 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 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. 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 this public offering is 100 million shares, accounting for% of the total share capital after issuance
20.28%。 This issuance is all new shares, and the original shareholders do not offer shares to the public.
The par value of each share is 1.00 yuan
The issue price per share is 13.23 yuan
Shanghai Stock Exchange
Section to be listed: Scientific Innovation Board
The total share capital after issuance is 493189000 shares
Sponsor (lead underwriter) Haitong Securities Company Limited(600837)
Co lead underwriter Guotai Junan Securities Co.Ltd(601211)
Signing date of prospectus: March 17, 2022
The sponsor Haitong Securities Company Limited(600837) arranged the subsidiary Haitong innovation Securities Investment Co., Ltd. to participate in the strategic placement of this offering. The number of placement was 4.00% of the number of strategic placement of this public offering, i.e. 400000000 shares, and the allocated amount was 5292000000 yuan. Haitong Chuangxin Securities Investment Co., Ltd. obtains the restricted term of the shares placed this time, which is 24 months from the date of the issuer’s initial public offering and listing.
Tips on major issues
This important notice is a summary notice. For the company risks and other important matters that investors need to pay special attention to, investors should carefully read the text of this prospectus. 1、 Gene therapy cdmo depends on the development of downstream gene therapy industry, and there is a risk that the development of gene therapy industry is less than expected (I) there are uncertain factors in the development of gene therapy industry
The issuer and its gene therapy cdmo industry are highly dependent on the development of downstream gene therapy industry. Globally and in China, the gene therapy industry has experienced twists and turns in the development process of the past 30 years, and there has been a period of development stagnation caused by safety problems; In recent years, although the gene therapy industry has accelerated its development and well controlled the safety problems with the continuous increase of listed drugs and clinical trials, it is still faced with the weakening of the advantages of the pipeline under research due to the rapid iteration of industry technology, the high price of drugs may lead to insufficient effective demand in the market, the small scale of the indication treatment market or more competition from traditional drugs Stricter supervision leads to a series of uncertain factors such as the difficulty of obtaining approval of new drugs, so the development prospect may be less than expected.
The gene therapy cdmo industry is highly linked with the downstream gene therapy industry. If the development of the gene therapy industry is less than expected due to safety, technology, price, indications, regulatory policies and other factors, it will have an adverse impact on the cdmo industry, and the issuer’s customers’ demand for cdmo services will weaken. (II) regulatory risk of gene therapy
Gene therapy is an emerging treatment. At present, only more than ten car-t products and adeno-associated virus products have been approved to market in the United States and Europe, and the experience of drug review and continuous supervision is limited. Among them, the technology of car-t is relatively mature, and the clinical research on safety and efficacy is relatively sufficient; The technology of oncolytic virus and AAV is more difficult, and the clinical research on safety and efficacy still needs more accumulation. In particular, the safety of AAV has attracted the continuous attention of FDA.
The scientific and industrial circles continue to discuss the safety and effectiveness of gene therapy. Global regulatory authorities such as FDA, EMA and nmpa have also adjusted regulatory regulations and policies according to various opinions on many occasions. While the overall regulatory trend tends to encourage the development of gene therapy, it also continues to emphasize the quality and safety of products.
China’s production standards and norms on gene therapy are still immature, the regulatory system is not comprehensive, and relevant regulations and policies are continuously adjusted according to the development of the industry. If there are medical safety incidents of gene therapy products in the future, which will lead to negative public opinion on the safety, practicability or effectiveness and ethics of gene therapy, it is possible to urge the regulatory authorities to implement stricter technical and experimental control over the gene therapy industry as a whole, and improve the difficulty of obtaining approval for clinical trials and listing of gene therapy products.
Facing the uncertainty of regulatory policy changes, if the company cannot adjust its business strategy in time to deal with changes in industry regulations and regulatory environment, its gene therapy cdmo business may be adversely affected. (III) there is some uncertainty in the path of gene therapy technology
1. Gene therapy cdmo technology path
At present, the issuer mainly provides services for R & D pipelines in preclinical and clinical phase I & II stages, and has accumulated more experience in process development, process validation, drug quality control technology, amplification production technology and project operation management in these stages. However, since the drug pipeline served has not yet entered clinical phase III trial, it has no production experience in these stages.
In terms of technology, clinical phase III and commercial phase production are different from preclinical and clinical phase I & II production in many technical considerations such as process characterization, commercial process amplification and continuous quality verification. At present, the issuer has carried out process characterization and other work, and the production scale has reached the requirements of clinical phase III. at the same time, it has the process amplification experience from small trial to pilot trial, the development experience of multiple quality methods and perfect quality management system, and has done some technical reserves for clinical phase III and commercial production.
However, in view of the cutting-edge nature of gene therapy, some cdmo process changes may occur due to the application of new technologies and changes in regulatory requirements during the promotion of the service pipeline from clinical phase I to phase III and beyond. Therefore, the technology accumulation formed by the issuer’s existing business may face uncertainty in the technology path for cdmo projects serving phase III and commercialization scale.
2. Downstream gene therapy technology path
In recent years, the exploration of gene therapy technology and mechanism and the development of clinical trials have continued to deepen, but there are still few gene drugs approved for marketing. In terms of mainstream drugs, imlygic, the oncolytic virus product of Amgen (Amgen), was approved by FDA and EMA in 2015, and other drugs approved by FDA and EMA are mainly AAV, car-t and other products; In China, nmpa approved one oncolytic virus product in 2005 and two car-t products in June and September 2021.
Gene therapy is a frontier and emerging field. Most drugs are in clinical trials, and there are some inherent uncertainties in its technical path. Among them, the technology of car-t is relatively mature, and the clinical research on safety and efficacy is relatively sufficient; The technology of oncolytic virus and AAV is more difficult, and the clinical research on safety and efficacy still needs more accumulation. In particular, the safety of AAV has attracted the continuous attention of FDA.
In view of the business characteristics of the issuer, such as focusing on the ind-cmc phase project, not providing phase III and commercial phase services, the main advantage field is oncolytic virus with higher process difficulty, and the clinical progress of relevant pipelines is fast, the pipelines served by the above cdmo project may face the risk of drug technology path failure, or the risk that the drug technology path needs to be adjusted when entering phase III. If such circumstances occur, the issuer’s cdmo project may not be able to be continuously promoted, or the developed process and quality control methods may not meet the requirements.
The uncertainty in the above technical path may cause the development of gene therapy industry to be less than expected, and bring certain risks to the company’s cdmo business operation. 2、 Business characteristics of the issuer’s gene therapy cro and cdmo (I) the whole chain service of gene therapy cro and cdmo has not been realized
At present, the issuer has the ability to provide cro services such as gene therapy vector development and gene function research for basic research of gene therapy, as well as cdmo services such as ind-cmc pharmaceutical research and GMP production of clinical samples for research and development of gene drugs.
However, based on the current business situation, the company’s gene therapy cro and cdmo customers are relatively independent and have great differences. Cdmo business mainly serves new drug R & D enterprises, and cro business mainly serves scientific research customers; The transformation of cro business and cdmo business is less, and there is no inevitable transformation relationship. Therefore, as far as the specific R & D pipeline is concerned, the company has not yet realized to provide it with complete and whole chain cro and cdmo services from early basic research, process development, efficacy test, clinical sample production to commercial production. (II) cdmo business execution projects and customer accumulation are relatively small
The cdmo business of the company has not developed for a long time, and the number of customers and executed projects are relatively small; In terms of business structure, at present, ind-cmc stage projects are the main ones, and there are relatively few clinical stage projects, all of which are clinical stage I & II; In addition, as of August 20, 2021, the genetic drugs covered by the issuer’s contract in hand are mainly oncolytic viruses, followed by AAV and cdmo projects of cell therapy, as follows:
Unit: 10000 yuan
Product category number of projects in hand (PCs.) contract amount not executed in hand (10000 yuan)
Oncolytic virus 222206058
AAV gene therapy 6 302356
Cell therapy 14548100
Others – 694.50
Subtotal 423125964
Note: cell therapy includes car-t, car-nk projects and their related plasmids, lentivirus projects, etc.
The issuer is committed to becoming a gene therapy service platform covering oncolytic virus, gene therapy vector, car-t products and other mainstream drugs, but due to different categories
