Source of this article: Times Finance Author: Wen Ruonan
Picture source: Tuchong Creative
Affected by the adjustment of the new crown epidemic prevention and control policy, nucleic acid detection exited, self-test antigen came on, and became a hot commodity in the market, with many companies jumping in.
On December 12, after review by the State Food and Drug Administration, two new coronavirus antigen detection reagent products of Zhengzhou Antu Bioengineering Co., Ltd. (hereinafter referred to as "Antu Biotechnology", 603658.SH) and Xiamen Weizheng Biotechnology Co., Ltd. (hereinafter referred to as "Weizheng Biotechnology", 839355.OC) were approved.
According to statistics from Times Finance, since December, seven companies have been approved for their COVID-19 antigen detection reagent products. So far, the State Food and Drug Administration has approved 42 new coronavirus antigen detection reagent products.
From the consumer side, it is already difficult to find a single set of antigen test kits on the market.
"The current tight supply problem in the market may be alleviated with the increase of approved manufacturers. The approval of many companies should be to ensure that the market demand is met as soon as possible." Zhang Lu, the sales director of an antigen reagent manufacturer, told Times Finance, "The recent antigen detection kits have become hard currency, and it is estimated that it will only last for a month or two, which is the recent sudden explosive growth. After the production capacity of each company is increased, it will be relatively stable. This situation will not continue forever."
Supply exceeds demand. , the ex-factory price increased by more than 96% in half a month.
On December 7, the National Health Commission released the "New Coronavirus Antigen Detection Application Plan" (hereinafter referred to as the "Plan"), which mentioned that the new coronavirus antigen self-test is applicable to those who need independent antigen testing, People in crowded places (large enterprises, construction sites, universities, etc.), elderly people at home and elderly people in nursing homes. Among them, "people who need autonomous antigen testing" mentioned that "all personnel can perform self-antigen testing at any time in accordance with the principle of autonomy and voluntariness."
In addition, the "Plan" also clearly stated that "reserves shall be carried out on a primary medical and health institution basis, and each primary medical and health institution shall reserve antigen detection reagents according to 15-20% of the total population served."
As soon as the above news came out, there were more and more discussions about antigen self-testing, and the demand for antigen test kits grew rapidly. According to previous reports from Red Star Capital Bureau, from November 28 to December 4, the transaction volume of JD Health’s (06618.HK) antigen detection kits increased by 344% compared with last week.
Times Finance visited and found that in the first week of December, many pharmacies in Guangzhou still had a small supply of antigen test kits. Among them, a staff member of the Neptune Star store told Times Finance on December 2, "If you want to buy antigen reagents, you must make a reservation first, and the earliest is next Tuesday (December 6)."
However, on December 13, Times Finance once again asked the aforementioned Neptune Star store about its in-store inventory. The relevant staff said, "It has been out of stock for a long time, and it may not be available for pre-orders now. I want to buy it myself, but I feel that I can't buy it now even if I have money." Another pharmacy staff said, "The store is temporarily out of stock, and the arrival time cannot be determined." With
in short supply, terminal prices have continued to rise. Guangzhou citizen Gao Yifan told Times Finance that on November 30, she spent 68 yuan to buy 2 boxes of 10-person " Corfu " brand new coronavirus antigen test kits. A week later, the price of the above-mentioned products had risen to 98 yuan. On average, the price per serving rose from 3.4 yuan to 4.9 yuan, an increase of about 44.12%.
According to the observation of Times Finance, COVID-19 antigen reagent products with a price of 4.9 yuan per serving are relatively common. On e-commerce platforms, there are even products with a discounted price of more than 10 yuan per serving. The ex-factory price of
is also rising. According to Times Finance, recently, the external quotations of many dealers of new coronavirus antigen reagent products have reached 4 yuan per copy, and they need to be purchased at regular intervals and at designated locations to purchase them.
On December 13, a relevant person from an antigen reagent manufacturer in Shandong told Times Finance that the price he quoted to customers in the first two weeks was 1.78 yuan/piece. However, due to rising raw materials, the current ex-factory price has risen to 3.5 yuan/piece, which means that the ex-factory price has increased by more than 96% in half a month.
product approvals are accelerating, and manufacturers are getting crazy calls
In order to meet the rising market demand, product approvals are also accelerating.
On December 2, Jiangsu Meike Medical Technology Co., Ltd.’s new coronavirus antigen self-test kit was approved after review by the State Food and Drug Administration. A week later, six companies including Bioda Biotechnology (Wuhan) Co., Ltd., Jidan Biotechnology Co., Ltd. (603387.SH) and Taipu Biosciences (China) Co., Ltd., Zhongshan Bioengineering Co., Ltd. (hereinafter referred to as "Zhongshan Bioengineering"), an wholly-owned subsidiary of Da'an Gene (002030.SZ), Antu Biotechnology, and Weizheng Biotech were approved one after another.
According to statistics from the State Food and Drug Administration, as of December 12, 42 companies have been approved for COVID-19 antigen detection reagent products.
A relevant person from the Da'an Gene Securities Department told Times Finance, "The production capacity of the new coronavirus antigen self-test kits of the subsidiary Zhongshan Bioengineering can reach more than 1 million doses per day. In the future, we will consider whether to expand production capacity based on market demand."
sales staff are even more busy. "It's been very busy recently, and the phone calls have been busy, one after another. The factory has enough manpower and will not recruit short-term workers for the time being. In addition to the people in the factory, we also have sales, and the company's sales can help." On December 7, Zhang Lu told Times Finance, "It's not just us, everyone can't buy it. I have communicated with other companies, and they are all queued up to the end of the month."
In less than a week, on December 13, Zhang Lu told Times Finance that some antigen reagent manufacturers have stopped taking orders. "Many of our colleagues in charge of sales have stopped taking orders because the delivery time cannot be guaranteed. In addition, we should finish the orders on hand first, probably out of this consideration."
On the same day, Times Finance learned from the above-mentioned relevant person of an antigen reagent manufacturer in Shandong that the company currently has no stock in stock and has received too many orders. The production schedule of antigen reagents has been scheduled to February next year, and the company is still further increasing production capacity.
Judging from the C-end e-commerce platform, the purchase links for multiple antigen test kits have been removed from the shelves. Many store customer service personnel told Times Finance that due to the shortage of orders and the delivery date could not be determined, they were removed from the shelves.
Market demand has surged, and the market size of antigen reagents has increased rapidly. In addition to domestically approved manufacturers, there are also companies trying to get a share of the pie through OEM production.
On December 9, Corfu Medical (301087.SZ) stated on the investor interaction platform that the Corfu brand products currently sold in China are OEM-produced by other antigen manufacturers.
Times Finance noticed from the Taobao e-commerce platform that the monthly sales of antigen test kits labeled with the Corfu brand exceeded 400,000 per link.
Many people in the in vitro diagnostic industry told Times Finance that the OEM production of COVID-19 antigen reagents is not an isolated case. Jiu'an Medical (002432.SZ) and Sino Biotech (300298.SZ) are also engaged in the OEM business of COVID-19 antigen reagent kits. Currently, these two companies are not on the domestic product approval list.
Times Finance saw from the e-commerce platform that the registrant name of the COVID-19 antigen kit marked with the "andon Jiu'an" trademark is "Biohan Biotechnology (Hefei) Co., Ltd." and the COVID-19 antigen kit labeled with the "Sinocare" brand comes from Nanjing Novezan Medical Technology Co., Ltd.
is asking for RMB 1 million to urgently recruit a sales director, and the factory will not stop working during the New Year
With the hot sales of the new crown antigen test kit, the entire industry chain has been activated internally and externally.
On December 6, a headhunter in the medical industry released recruitment information for the sales director of antigen in the industry group. The job responsibilities clearly mentioned that he would be responsible for the national sales of the new crown antigen product line. On the same day, Times Finance consulted the headhunter, who said that many companies are currently recruiting. A week later, the aforementioned headhunter told Times Finance that only one company was now recruiting, and the others were almost certain, with annual salaries in the 1 million yuan range.
In addition to urgently recruiting a sales director, now that the new year is approaching, the production line is also experiencing some labor demand. On December 13, Times Finance learned from a recruitment agency that an antigen reagent manufacturer in Zhejiang was recruiting antigen test paper workers.
"We are recruiting about 100 to 200 people, and it costs 18 yuan an hour, from 7 a.m. to 7 p.m., with food and accommodation included, and two or three days off during the New Year. The hourly wage in January should rise to about 20 yuan to 22 yuan, and red envelopes will be given during the Chinese New Year." Wang Jie, a labor agency in Shaoxing, Zhejiang, told Times Finance.
Third-party organizations that specialize in handling medical device qualifications have also sensed business opportunities and wandered in the gray area of the industry chain. The
antigen kit belongs to the category three medical devices in China. The manufacturer needs to obtain the relevant medical device registration certificate , and the dealer also needs to obtain the corresponding category 3 medical device business qualification. On December 9, Times Finance consulted a relevant person from a third-party organization as a company. They stated that the COVID-19 antigen self-test kit belongs to the 6840 in vitro diagnostic reagent in the third category of medical devices. If the company is approved for this business qualification, it can sell the COVID-19 antigen reagent.
"We have been in this industry for a long time. Recently, we have been processing a lot of antigen qualifications, and the teachers in the registration department are very busy. The all-inclusive package includes personnel, addresses, and agency accounting. Now the fastest processing time is 25 working days. You can also expedite the process and pay more." The person told Times Finance.
The cost of agency qualifications is also rising. On December 9, the all-inclusive expedited price of the above-mentioned third-party agency was 38,400 yuan. By December 14, this figure had risen to 42,400 yuan. The above-mentioned relevant person explained that "the main reason is that the cost of personnel has increased."
According to this person, to obtain the qualification to operate antigen reagents, a company must have a supervisory inspector, inspector, and quality director. The supervisory inspector can also be the person in charge of quality. Taking the Dongguan area as an example, the quality person in charge needs to have more than three years of working experience in a Class III medical device company. However, he said that this employment experience is not easy to obtain, so they can issue it on their behalf for a fee of NT$500.
Regarding matters related to agency medical device qualifications, lawyer Li Sheng, chief partner of Beijing Zhipu Law Firm, told Times Finance, "As an enterprise, when applying for a certain license from the administrative agency, the information submitted must be true. This is self-evident. This is clearly stated in Article 62 of the Administrative Licensing Law that 'the licensee shall truthfully provide relevant information and materials.' Otherwise, it shall be revoked in accordance with Article 69. Article 79 further stipulates, ‘If a licensee obtains an administrative license through improper means such as deception or bribery, the administrative agency shall impose administrative penalties in accordance with the law; if the administrative license obtained is directly related to public security, personal health, life and property safety, the applicant shall not apply for the administrative license again within three years; if a crime is constituted, criminal liability shall be pursued in accordance with the law.” ”
On December 13, the State Food and Drug Administration held a video dispatch meeting to strengthen the quality and safety supervision of new coronavirus antigen detection reagents. The meeting pointed out that recently, ten new optimization measures for epidemic prevention and control and a new coronavirus antigen detection application plan have been introduced, which have put forward new requirements for the quality and safety of new coronavirus antigen detection reagents. All new coronavirus antigen detection reagent registrants and regulatory authorities must further improve their political position, deeply understand the special importance of strengthening the quality supervision of antigen detection reagents, and ensure the quality and safety of antigen detection reagents with a more responsible spirit and more solid work.
(At the request of the interviewee, Zhang Lu, Gao Yifan, and Wang Jie are all pseudonyms in this article.)
