After announcing the development of domestic covid-19 antigen detection kit, Hybio Pharmaceutical Co.Ltd(300199) ( Hybio Pharmaceutical Co.Ltd(300199) . SZ) welcomed a letter of concern from Shenzhen Stock Exchange (GEM concern letter [2022] No. 150). Two days ago, after the company announced the layout of this hot field, the share price continued to rise sharply in recent days.
Most of the listed companies that have been approved covid-19 covid-19 antigen detection kit in China have "precipitated" this business in the past, while Hybio Pharmaceutical Co.Ltd(300199) with long-term layout of polypeptide drug research and development is obviously a "halfway monk".
Can the company's covid-19 antigen detection kit registration be approved in the future? How much will it boost the performance after the approval and listing? These remain to be tested by time.
letter to welcome attention after the sharp rise
Even if there is a letter of concern at this time, the share price of Hybio Pharmaceutical Co.Ltd(300199) has risen for two consecutive days.
The first financial reporter found that as early as March 13, 2022 (last Sunday), the official website of the National Center for infectious diseases clinical research in Shenzhen (hereinafter referred to as the National Center for infectious diseases research) published the news of the joint COVID-19 antigen detection kit with Hybio Pharmaceutical Co.Ltd(300199) .
According to the official website information, in March 11th, the national infectious disease research center and the third people's Hospital of Shenzhen (hereinafter referred to as the three hospital of Shenzhen) signed a binding letter of intent with Hybio Pharmaceutical Co.Ltd(300199) , and authorized Hybio Pharmaceutical Co.Ltd(300199) to carry out the commercial development, registration and sale of the household New Coronavirus antigen detection reagent. The national infectious disease research center is jointly organized by Shenzhen Municipal Health Commission and Shenzhen three hospitals. It aims to carry out cutting-edge medical research, promote medical research enterprise cooperation, and carry out major epidemic emergency research. Shenzhen third hospital is the only designated treatment hospital for covid-19 pneumonia patients in Shenzhen. It is the "main battlefield" of epidemic prevention and control in Shenzhen. It has accumulated rich treatment experience and case data of covid-19 patients clinically, and has advantages in virus strain research and antigen detection.
The above news also said that "the three parties will jointly provide China with covid-19 virus detection solutions". After the signing of the binding intention agreement, the national infectious disease research center and the three hospitals in Shenzhen will quickly complete the verification of real samples and antigen kit clinical research on clinical sample resources and detection resources, Cooperate with Hybio Pharmaceutical Co.Ltd(300199) to develop products with better sensitivity and specificity to solve the common problems such as missed detection and false positive in antigen detection.
Stimulated by this good news, the Hybio Pharmaceutical Co.Ltd(300199) share price rose sharply at the opening of trading in the morning of March 14 (Monday). In March 14th, Hybio Pharmaceutical Co.Ltd(300199) formally disclosed the news of the development of the "household New Coronavirus antigen detection reagent" in collaboration with the above-mentioned national infectious disease research center and the three hospital of Shenzhen, and issued the "risk warning". The signing of the contract is only a letter of intent for authorization of the patent. There is still uncertainty in the relevant patent declaration.
Hybio Pharmaceutical Co.Ltd(300199) said that the company's covid-19 test kit is currently in the clinical sample testing stage, and it still needs to be tested by China food and Drug Identification Research Institute in the later stage. "In terms of clinical research, there is a risk that the effect does not meet the expectations, the clinical progress and whether it can be approved for listing in the future are uncertain, and the economic benefits and impact on the company's performance in the future are uncertain."
Even after saying so much, the "enthusiasm" of investors remains unabated. On March 15, the Hybio Pharmaceutical Co.Ltd(300199) share price continued to rise as soon as the morning trading opened. After closing in the afternoon, Hybio Pharmaceutical Co.Ltd(300199) announced that it had received a letter of concern from the management department of GEM companies of Shenzhen Stock Exchange.
According to the letter from the Shenzhen Stock Exchange, Hybio Pharmaceutical Co.Ltd(300199) disclosed that the national infectious disease research center and the three hospital of Shenzhen were willing to license the family wide New Coronavirus exclusive antigen detection kit (B P301-F7 and P301-H5 two antibodies, and subsequent patents related to the project) to the company. Please Hybio Pharmaceutical Co.Ltd(300199) supplement the type, application and acceptance of the above-mentioned patent, patent number, content of patent protection, approximate time required for similar patents from application to authorization, etc.
In recent days, under the background of the multi-point outbreak of the epidemic in China and the "opening" of covid-19 antigen self-test products, covid-19 antigen detection concept stocks in the capital market have become a hot target for investors, and the share prices of many listed companies of covid-19 antigen detection products have soared. Regulators are worried about whether listed companies have "rub hot spots" under such circumstances.
The Shenzhen Stock Exchange Requested Hybio Pharmaceutical Co.Ltd(300199) to explain whether the announcement meets the information disclosure standard and whether the company actively caters to the market hot spots and hypes the company's share price in combination with the progress of the framework agreement and other agreements related to market hot spots disclosed by the company in recent three years.
In addition, the Shenzhen stock exchange requires to verify the trading of the company's shares by the company's controlling shareholders, actual controllers, shareholders holding more than 5%, directors, supervisors, senior managers and their immediate family members in the last three months, as well as whether there is a reduction plan in the next three months, Report the transaction details and self inspection report, and explain whether there is speculation in the stock price to cooperate with the reduction of shareholders' holdings.
In addition, the Shenzhen Stock Exchange also asked the company to explain the recent media interviews, institutional and investor research, reply to investor consultation, self media publicity, whether there is a violation of the principle of fairness of information disclosure, and whether there are other violations of information disclosure.
On March 15, Hybio Pharmaceutical Co.Ltd(300199) declined the interview of the first financial reporter. However, a person close to Hybio Pharmaceutical Co.Ltd(300199) said that the company had arranged the R & D of covid-19 antigen detection kit earlier, but it just reached the node of disclosure conditions recently, and there was no "hot spot" and stock price speculation. For details, you can pay attention to the company's follow-up announcement.
subsequent layout is still pending
On the whole, the focus of the regulators is whether Hybio Pharmaceutical Co.Ltd(300199) is really in the business field of covid-19 test kit, and whether the company is capable of developing and listing this business.
According to the letter of concern from Shenzhen Stock Exchange, Hybio Pharmaceutical Co.Ltd(300199) developed covid-19 Test Kit adopted technical route , company has listed in vitro test reagent products, production experience and production line of in vitro test reagent products, and in combination with the above situation, explain this research and development The process and time needed to produce fast New Coronavirus antigen detection kit for household use; And whether clinical trials have been conducted at present. If so, describe the sample size of clinical sample tests, specificity, sensitivity and other indicators .
first finance and economics reporter found that most enterprises that have been approved covid-19 covid-19 antigen self-test kit have business foundation "precipitation", that is, they have arranged this business earlier and become the performance support of the company .
For example, as early as November 2020, the New Coronavirus antigen detection kit (colloidal gold method) approved by Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) .SZ) was approved by the State Administration of pharmacy for emergency examination and approval, and became the first approval test for COVID-19 virus antigen in China. The annual report disclosed that the company's covid-19 antigen detection reagent was sold in Germany, Belgium, the United Kingdom and other countries in Europe, and a large number of covid-19 antibody detection reagents were exported overseas, driving the rapid growth of the company's performance.
In addition, many kinds of kits have been certified and sold in the world. For example, Andon Health Co.Ltd(002432) US subsidiary has been authorized by FDA and EUA and sold in the United States Shenzhen Yhlo Biotech Co.Ltd(688575) has been certified by Japan PMDA and has received orders to be sold and listed in Japan Bgi Genomics Co.Ltd(300676) wholly owned subsidiary has obtained the EU CE certificate and the listing approval of Saudi Arabia Food and drug administration Contec Medical Systems Co.Ltd(300869) has been registered by the competent EU authorities and is allowed to carry out overseas sales.
In contrast to Hybio Pharmaceutical Co.Ltd(300199) , the company has been laying out the R & D, production and sales of polypeptide drugs for a long time, and has been working in this field for 20 years. In November 2021, Hybio Pharmaceutical Co.Ltd(300199) announced that covid-19 virus polypeptide nasal spray was developed in cooperation with the Institute of Microbiology, Chinese Academy of Sciences.
In recent years, Hybio Pharmaceutical Co.Ltd(300199) performance has been sluggish. The company disclosed that it had suffered performance losses for three consecutive years from 2019 to 2021. In 2021, the company's net profit after deducting non recurring profits and losses is expected to suffer a loss of RMB 380 million to RMB 430 million.
Hybio Pharmaceutical Co.Ltd(300199) said that as of September 30, 2021, the company's book monetary capital balance was 215 million yuan and the asset liability ratio was 58.65%. In view of the large capital demand in the existing research projects, if the credit policy and the smoothness of financing channels change, the company may bear certain capital risks.
More importantly, when Hybio Pharmaceutical Co.Ltd(300199) announced the development of domestic rapid covid-19 virus antigen detection kit, at the same time, 10 manufacturers of similar products in China have been approved, and more than 70 similar products are still under approval by the State Drug Administration Hybio Pharmaceutical Co.Ltd(300199) said that there is still uncertainty about whether the company's products can be listed and approved, and there is great uncertainty about the impact on future performance.
The person in charge of a large pharmaceutical chain group in China told the first financial reporter that at present, covid-19 antigen self-test kit is difficult to order and arrive all over the country. "With the increase of approved enterprises, the price and profit space are far less impressive than expected".
The Shenzhen Stock Exchange also asked Hybio Pharmaceutical Co.Ltd(300199) to combine the company's funds and liabilities, as well as the company's COVID-19 nasal spray project, the research and development of the fast New Coronavirus antigen detection kit, the funds needed for production, and the funds needed for daily production and operation.
