Polypeptide drugs Shengnuo Biotechnolog IPO was finally accepted

Recently, the Shanghai stock exchange accepted the IPO of Chengdu Shengnuo Biotechnology Co., Ltd., and Minsheng securities acted as the sponsor.

Shengnuo Biotechnolog IPO was finally accepted plans to raise 349 million yuan for the production line project of polypeptide API with an annual output of 395 kg, the technical transformation project of preparation industrialization and the upgrading project of Engineering Technology Center.

On June 29, capital state learned that recently, Chengdu Shengnuo Biotechnology Co., Ltd. (hereinafter referred to as ” Shengnuo Biotechnolog IPO was finally accepted “) technology innovation board IPO was accepted by the Shanghai Stock Exchange, and Minsheng securities acted as the sponsor.

Photo source: Official Website of Shanghai Stock Exchange

In September 2014, Guojin securities and Shengnuo Biotechnolog IPO was finally accepted signed the coaching agreement. In April 2018, after friendly negotiation, both parties agreed to terminate the cooperation and terminate the counseling agreement signed by both parties.

On September 26, 2018, Shengnuo Biotechnolog IPO was finally accepted received the guidance of Minsheng securities. On May 8, 2019, the company applied for change to be listed on the sci tech Innovation Board of Shanghai Stock Exchange;

In June of the same year (2019), the company said that according to the company’s development needs, the original application for listing on the sci tech Innovation Board of Shanghai Stock Exchange was changed to Shenzhen Stock Exchange gem.

On May 27, 2020, sinobio will change its listing board from Shenzhen Stock Exchange growth enterprise market to Shanghai Stock Exchange science and technology innovation board.

The company is a high-tech enterprise with the core technology of peptide synthesis and modification. Its main business includes providing pharmaceutical research and customized production services for domestic and foreign pharmaceutical enterprises in the research and development of polypeptide innovative drugs, independent research and development, production and sales of polypeptide generic drugs and preparation products with large market capacity and strong competitiveness at home and abroad, as well as polypeptide drug production technology Transfer of services. In addition, the company is also engaged in the processing of levosimendan preparations and the production and export of levosimendan API.

According to the financial data, the revenue of sinobio in 2017, 2018 and 2019 were RMB 194 million, RMB 278 million and RMB 327 million respectively; the corresponding net profits in the same period were 33.904 million yuan, 29.8613 million yuan and 48.1317 million yuan respectively.

The specific listing criteria selected by the issuer are: the expected market value is no less than RMB 1 billion, the net profit in the last two years is positive and the accumulated net profit is not less than RMB 50 million, or the expected market value is not less than RMB 1 billion, the net profit in the latest year is positive and the operating income is not less than RMB 100 million.

Shengnuo Biotechnolog plans to raise 349 million yuan for the production line project of polypeptide API with an annual output of 395 kg, the technical transformation project of preparation industrialization and the upgrading project of Engineering Technology Center.

Photo source: Company prospectus

As of the disclosure date of the prospectus, Lepu medical (300003. SZ), a listed company, held 10.80% equity of sinobio, ranking the second largest shareholder list of the company. The actual controllers of sannuo are Wen Yongjun and Malan Wen.

Shengnuo Biotechnolog admits that the company has the following risks:

（1） The risk of medical system reform

The pharmaceutical industry is one of the key industries in China. Pharmaceutical products are special commodities related to people’s life, health and safety. At the same time, the pharmaceutical industry is also a highly regulated industry. The regulatory authorities include national and local drug regulatory departments and health departments at all levels. They formulate relevant policies and regulations within their respective scope of authority to supervise the whole industry.

For example, in April 2016, the general office of the State Council issued the notice on the key tasks of deepening the reform of the medical and health system in 2016, which clearly required provinces to promote the “two vote system” throughout the province;

In May 2016, the general office of the State Council issued the notice on printing and distributing the pilot scheme of drug marketing license holder system. During the pilot period, drug research and development institutions or scientific research personnel in the pilot administrative region can become drug marketing license holders;

In November 2018, the fifth meeting of the Central Committee for comprehensive deepening reform deliberated and approved the pilot program of centralized drug procurement organized by the state. Public medical institutions in 11 cities were taken as the main body of centralized procurement. The national pilot working group and its office were set up by the National Health Insurance Bureau, the National Health Commission, the State Drug Administration and other relevant national departments to promote the formation of an alliance and centralized procurement of pilot cities Purchase;

In September 2019, the pilot work of centralized drug procurement will be extended to the whole country.

At present, China is in the period of economic restructuring, and various structural reforms are gradually deepening. With the deepening of China’s medical and health system reform and the gradual improvement of social medical security system, the policy environment of China’s medical and health market may face significant changes, and the regulatory policies related to the industry are still improving and adjusting.

If the company can not timely adjust its business strategy to adapt to the changes of market rules and regulatory policies brought about by the reform of medical and health system, it will be difficult to meet the needs of medical institutions represented by public hospitals, which will have adverse effects on the operation of the company.

（2） Market risk of drug price adjustment

Since 1998, the national development and Reform Commission has made many price reductions in the pharmaceutical market. In recent years, the National Health Commission and other regulatory departments have issued various notices to control the proportion of drugs and the growth rate of medical expenses. In May 2015, the national development and Reform Commission, the National Health Commission and other departments jointly issued the “notice on printing and distributing opinions on promoting drug price reform”.

Since June 2015, except for narcotic drugs and category I psychotropic drugs, the drug prices set by the original government will be cancelled, the drug procurement mechanism will be improved, and the role of medical insurance in cost control will be brought into play. The actual transaction price of drugs is mainly formed by market competition.

Among them:

(1) for the drugs paid by the medical insurance fund, the medical insurance department, together with the relevant departments, shall formulate the procedures, basis, methods and other rules for the formulation of medical insurance drug payment standards, and explore the establishment of a mechanism to guide the reasonable formation of drug prices;

(2) for patented drugs and exclusive drugs, an open, transparent and multi-party negotiation mechanism shall be established to form the price.

With the continuous improvement and improvement of drug price system, medical insurance system, centralized drug procurement bidding system and other systems, and further strengthening the implementation of medical insurance cost control, the company’s product sales price will face the risk of downward adjustment in a long period of time, which will have an adverse impact on the company’s profitability.

（3） Risk of R & D failure

The company always regards technological innovation and R & D as the driving force of the company’s development, and continuous R & D investment is the core of driving the whole business link. In recent years, the company has continuously improved peptide synthesis and modification technology to carry out pharmaceutical research and customized production services more efficiently, and has continued to invest in the research and development of peptide raw materials and peptide preparations.

At present, three varieties have applied for registration approval with the State Drug Administration, and three varieties have obtained clinical trial license.

Although the implementation of these R & D projects can lay a good foundation for the company’s technical progress and long-term development, due to the long development cycle and technical difficulty of peptide raw materials and preparations, there is uncertainty whether the product can be successfully developed. The company is faced with the risk that the R & D progress or approval results of R & D projects are not as expected, resulting in R & D failure.

（4） Risks of R & D project industrialization

Although the company has carried out relevant market research for each R & D project in the early stage, if the product R & D fails to meet the changing market demand, or the product is not accepted by the market, or there are similar competitive products in the treatment field, efficacy, safety and other similar products on the market, it will bring uncertainty on whether the company’s R & D achievements can be successfully transformed into business results Faced with the risk that the early R & D investment can not be recovered, which will have an adverse impact on the company’s operating performance.

（5） Risk of loss of core technical personnel

Having a high-quality, strong professional ability, stable technical personnel team is an important guarantee to maintain the leading edge of technology. The rapid growth of the peptide product R & D and production industry makes the competition for talents increasingly fierce. Whether the company can cultivate and retain the core technical personnel is the key to maintain the competitive advantage of the company. Although there has never been a large-scale loss of core technical personnel in the past operation history of the company, the loss of core technical personnel due to industry talent competition, lack of incentive mechanism and other factors in the future will have a negative impact on the company’s production and operation.

（6） Risk of declining demand for peptide drug research and development

The peptide pharmaceutical research and customized production services provided by the company, as well as the sales of polypeptide raw materials, are closely related to the R & D investment of downstream pharmaceutical enterprises. If the market demand of peptide drugs can not reach the expected scale in the future, pharmaceutical enterprises will reduce the research and development expenditure of polypeptide drugs significantly, which will lead to the reduction of the demand for peptide products and services of the company. If the company fails to timely The development of other customer resources may have an adverse impact on the company’s operating performance.

（7） The risk of overseas business relying on distributors’ channels

The final customers of the company’s overseas sales are relatively scattered, and the regulatory requirements for the import of API products in different customer locations are not the same, and the product demand of a single customer is small. If the company directly connects with it, the cost will be higher. In order to seize the market share of foreign API more effectively, the company mainly cooperates with distributors with rich customer resources and high reputation to carry out overseas sales.

If the distributor channel of overseas sales in the future is blocked or the sales is not smooth, and the company fails to develop other sales channels in time, it will have an adverse impact on the company’s business performance.

（8） The risk of adverse impact of Xinguan epidemic on the company’s business performance;

A novel coronavirus pneumonia outbreak began in January 2020 at home and abroad. With the spread of the epidemic worldwide, the economic and macro environment at home and abroad will continue to be affected to a certain extent for a long time, thus continuing to affect the daily production camp of domestic enterprises.

At present, the global epidemic outbreak has a great impact on the export and delivery of API products of the company. The delivery time of the company’s manual orders is constantly delayed, resulting in the risk of difficult delivery of export API products in the short term. It is expected that the export and sales of sannuo biopharmaceuticals will gradually resume after the epidemic situation in foreign countries gradually stabilizes in the future.

But if the novel coronavirus pneumonia epidemic is aggravated further in the world or is not controlled for a long time, it may lead to the long-term failure to deliver the export orders, the stagnation of overseas customers’ research and development projects, and the obstruction of international cooperation.

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