On April 22, the domestic gene sequencing leader Shenzhen Huada Gene Co., Ltd. (hereinafter referred to as “Huada Gene”, 300676) issued an announcement, and the Shenzhen Stock Exchange sent a letter of concern to the company, in view of the company’s recent disclosure of the new crown virus produced. The nucleic acid detection kit has obtained relevant qualification certificates or sales announcements in many countries or regions such as the European Union, the United States, Japan, and Australia. At the same time, the stock price has risen sharply recently, and it is required to supplement the relevant matters.
Additionally explain the following points: 1. The validity period of the company ’s aforementioned qualification certificate or sales license, and whether there is a risk that it cannot be renewed after expiration; 2. Explain the Test kit sales in the aforementioned market, market share, market competition in the same industry, etc., and the possible impact on the company’s future production and operation, combined with the sustainability of demand to alert investors to risks; 3. Explain whether the company exists It should disclose undisclosed information or major events in the planning stage; 4. Explain whether the company violates the fairness of information disclosure; 5. Combine the company’s operating performance, stock price changes, and comparison with the valuation of listed companies in the same industry, etc. Fully alert investors to the risks; 6. Check the company’s controlling shareholders, actual controllers, other shareholders, directors, supervisors, senior managers and their close relatives who have held more than 5% of the company’s shares in the past month, and explain the situation Whether there is any insider trading or market manipulation, whether there are any reduction plans in the next 6 months, and report the transaction details and self-examination Report; 7. Other matters that need to be explained.
According to the company ’s previous disclosure, after the outbreak of the new crown epidemic, BGI started to develop relevant kits in early January 2020, and completed the initial research and development in only 72 hours And after passing the strict kit production process and quality control, the official announcement on January 14 completed the development of a new coronavirus nucleic acid detection kit (fluorescent PCR method).
Up to now, the new coronavirus nucleic acid detection related products have obtained the medical device registration certificate issued by China National Drug Administration (NMPA), obtained the EU CE certification, and obtained the US food The FDA has issued an Emergency Use Authorization (EUA), passed the Japanese PMDA certification, and obtained the Australian TGA registration.
While providing new crown detection kits and establishing “Fire Eye” laboratories at home and abroad to improve local detection capabilities, BGI ’s stock price has also risen synchronously. Since the beginning of this year, the stock price of BGI has risen nearly 60%. Especially in the last 8 trading days, the cumulative increase has exceeded 23%. On April 23, the closing price of BGI was 107.86 yuan / share, which was 2.48% lower than the previous day’s closing price.
In addition, according to the performance forecast for the first quarter of 2020 released by Huada Gene on the evening of April 9, the net profit attributable to shareholders of listed companies in the first quarter is expected to be 133 million yuan-142 million yuan A year-on-year increase of 35% -45%. The announcement mentioned that during the reporting period, due to the impact of the new coronary pneumonia epidemic, the market’s demand for new coronavirus testing kits has increased significantly. The infection prevention and control business and the precision medical testing integrated solution business have achieved rapid growth during the reporting period Operating income is expected to increase by approximately 30% -40% over the same period last year.