In the past two weeks, the State Food and Drug Administration has successively approved 10 new coronavirus antigen detection reagent products.
According to the website of the State Drug Administration (hereinafter referred to as the "National Drug Administration"), on December 23, after review by the State Administration of Drug Administration, the approval of Dana (Tianjin) Biotechnology Co., Ltd. and Beijing Bell Bioengineering Co., Ltd. 2 new coronavirus antigen detection reagent products.
Up to now, the State Food and Drug Administration has approved 46 new coronavirus antigen detection reagent products.
On December 22, the State Food and Drug Administration reviewed and approved two new coronavirus antigen detection reagent products of Aveco Biotechnology Co., Ltd. and Mike Biological Co., Ltd.
On December 12, the State Food and Drug Administration reviewed and approved two new coronavirus antigen detection reagent products from Zhengzhou Antu Bioengineering Co., Ltd. and Xiamen Weizheng Biotechnology Co., Ltd.
On December 11, Zhongshan Bioengineering Co., Ltd.'s new coronavirus antigen detection reagent product was approved.
On December 9th, the State Food and Drug Administration reviewed and approved the detection of 3 new coronavirus antigens by 3 companies, Bioda Biotechnology (Wuhan) Co., Ltd., Jidan Biotechnology Co., Ltd. and Taipu Biosciences (China) Co., Ltd. Reagent products.
Just on December 8, the State Food and Drug Administration issued the "Announcement on Extending the Validity Period of the Registration Certificate of New Coronavirus Antigen Detection Reagents" (2022 No. 114), which emphasized that the State Food and Drug Administration has approved 36 new coronavirus antigen detection reagents , the drug supervision and management department will continue to speed up the review and approval of related products, strengthen the post-marketing supervision of related products, and ensure product quality and safety.
Based on this calculation, from December 9 to December 23, within two weeks, the State Food and Drug Administration has approved 10 new crown antigen detection products.
Enterprises are busy expanding production, 24 hours of production
With the optimization and adjustment of epidemic prevention and control policies, the number of new crown infections in various places has surged, and the demand for antigens has also "exploded overnight". The approval of antigens has accelerated, but it may take time to alleviate the market shortage.
On December 23, The Paper journalists called several listed companies as investors.
The staff in the office of the Secretary of the Board of Directors of Antu Biology said that basically the antigen detection reagent products will not be launched until the end of the month, and they are still in production, so the production capacity is not easy to measure.
After the product is launched, it will be sold nationwide.
The staff of the Securities Affairs Department of Daan Genomics stated that the production capacity of the new coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) developed by its wholly-owned subsidiary Zhongshan Bioengineering Co., Ltd. (hereinafter referred to as "Zhongshan Biology") can reach More than 1 million servings per day.
However, the staff member said that he did not know the sales situation, and the subsidiary company was responsible for it.
On December 19, Daan Gene stated on the investor interaction platform that the company's wholly-owned subsidiary Zhongshan Biology has entered a 24-hour continuous production state and has been selling to the domestic market.
On December 16, Zhongshan Bioengineering Co., Ltd. issued a "statement" on its official website, saying that the company is focusing on increasing production and expanding capacity, and can accelerate the production of new crown antigen reagents in the short term, and take practical actions to ensure stable production and supply.
At the same time, Zhongshan Biology promises to strictly abide by the government's centralized procurement price, and calls on partners and other suppliers to jointly maintain market price stability.
According to a previous report by The Paper, Zhijiang Bio said that the company's products are in short supply and are expanding production capacity, and strive to expand the production capacity by four times in December and January next year.
Yahuilong said that due to the impact of the epidemic, the company's current daily production capacity is 6-7 million servings.
Its self-developed and produced novel coronavirus antigen detection reagent (colloidal gold method) is currently in short supply. It is mainly supplied to Guangdong Province, especially Shenzhen, giving priority to medical institutions and pharmacies and other places that are urgently needed by the masses.
Mingde Biology stated on the Shenzhen Stock Exchange Interactive Exchange that the company will ensure the production of antigen detection kits through various methods such as active recruitment and multiple shifts.
The company has approved the ex-factory price of antigen products according to the production and operation costs, and has maintained a stable supply.
Regulators move to curb antigen markups
As more and more products are approved to enter the market, competition for COVID-19 testing products is intensifying.
Mike Bio announced at noon on December 23 that the company's new coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) has obtained a medical device registration certificate in China, marking that the company can provide the domestic market with adaptable all-scenario The overall solution for new crown virus detection will help to further enhance the competitiveness of the company's new crown virus detection products and provide more assistance for epidemic prevention.
Mike Bio once admitted in the third quarter report of 2022 that with the in-depth development of centralized procurement of new crown testing products and the intensification of market competition, the ex-factory prices of new crown testing products continued to decline, and the gross profit margin shrank.
The number of outbound tests of the company's new crown nucleic acid detection products increased by 93.06% compared with the first three quarters of last year, revenue fell by 23.08% year-on-year, and the average sales gross profit margin dropped by about 20 percentage points; as far as the third quarter is concerned, the number of outbound tests for new crown nucleic acid detection products Compared with the third quarter of last year, it increased by 86.13% year-on-year, and sales revenue fell by about 40.05% compared with the third quarter of last year. Therefore, the new crown nucleic acid detection products have a greater impact on the company's overall performance.
In the third quarter report of 2022, Jidan Bio pointed out that in the first three quarters of 2022, the company's accumulative income from the new crown business was 562 million yuan.
From a single quarter perspective, the proportion of new crown business revenue continued to decline in the first three quarters.
There is also some chaos in antigen sales.
Weizheng Biotech issued a "Solemn Statement" on its official website on December 14, saying that some individuals or companies in the market without their legal authorization, promoted and sold products produced by Zhengbio through WeChat Moments, e-commerce platforms and other online channels. Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method), and some individuals or companies sell this product at a high price.
Relevant departments are also stepping up efforts to investigate and deal with behaviors such as selling antigen detection kits at high prices.
On December 20, the State Administration for Market Regulation held a special press conference on price stability and quality assurance of epidemic-related drugs and medical supplies, announcing the cooperation between the central government and the Beijing Municipal Bureau of Market Supervision to carry out joint inspections on antigen detection reagents.
Just this month, Beijing Wantuo Film and Television Culture Media Co., Ltd. sold antigen detection kits of 25 pieces per box at a price of 250 yuan, which was much higher than the price of similar antigen detection kits in the surrounding market at the same time.
The Haidian District Market Supervision Bureau of Beijing has filed a case for investigation into the company's alleged violations of price gouging and unlicensed operation, and plans to impose an administrative penalty of 300,000 yuan.
As of the close on December 23, Mike Bio closed up 6.80% to close at 18.84 yuan; Antu Bio closed up 5.05% to close at 58.92 yuan; Weizheng Bio closed up 1.43% to close at 16.99 yuan; Jidan Bio closed up 3.32% to close at 13.70 yuan; Daan Gene closed up 0.06% to close at 16.26 yuan; Zhijiang Biology closed up 1.12% to close at 36.89 yuan; Yahuilong closed up 5.26% to close at 22.82 yuan; It closed up 7.32% to close at 64.93 yuan.