Since the National Health Commission issued a document on March 11 to incorporate covid-19 antigen detection into the application, in just six days, the centralized purchase price of relevant detection products is almost "halved", and the lowest price is 7.9 yuan / person.
"In fact, only within 2-3 days after covid-19 antigen detection reagent was put on the market, Tianjin pharmaceutical procurement center started the centralized maintenance of antigen detection reagent product information." Liang Jialin, an expert in health insurance policy publicity and education and Secretary General of the value medical advisory expert committee, said in an interview with China first finance and economics.
Liang Jialin said that local medical insurance departments intervened against the pricing of the original test reagent in less than a week, and the work of the reagent in the fields of price, quality control and use will be carried out more smoothly.
On January 17, at an export commodity inspection point at Pudong International Airport, Chinese customs officers photographed the covid-19 virus antigen detection kit exported to France. Xinhua News Agency
price needs "low linkage"
On the 14 day, the Tianjin medical purchasing center issued the notice on the centralized maintenance of New Coronavirus antigen detection reagent. As of now, a total of 7 provinces, including Guangdong, Zhejiang and Lu Jin Alliance (Shandong and Shanxi constitute drug purchasing alliance), Henan, Hubei, Inner Mongolia and so on, have started the COVID-19 antigen detection reagent collection.
Among the provinces that have announced the results of the successful election, Guangdong and Henan announced that Guangzhou Guangzhou Wondfo Biotech Co.Ltd(300482) won the election, and the price of the election was adjusted to 9.8 yuan / person.
Lu Jin Alliance announced five successful enterprises (including Shenzhen Huada Yinyuan, Beijing Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Wuhan Wuhan Easy Diagnosis Biomedicine Co.Ltd(002932) , Zhejiang Orient Financial Holdings Group Co.Ltd(600120) biology and Tianjin boaosai Biology), with an average winning price of about 8.3 yuan / person. If calculated according to the centralized purchase price of antigen detection products in Guangdong Province at 16.8 yuan / person in April 2021, the average price reduction of this centralized purchase is nearly 50%. In addition, the above five selected enterprises need to promise that the daily supply of Shandong and Shanxi is 20 million.
It is worth noting that many provinces have made restrictions on the rules of centralized purchase. For example, Shandong stipulates that enterprises need "low linkage" while declaring the lowest and highest bid price. Inner Mongolia also mentioned in the rules of centralized purchase that "in principle, the purchase price is not higher than the online price of other provinces and cities".
"This means that the results of this centralized purchase in Shandong will clearly focus on the final quotation, and the price difference of shortlisted enterprises will be relatively small." Zhao Heng, founder of latitudehealth, a medical strategy consulting company, said in an interview with China business that the above rules also show that the price of covid-19 antigen detection products will continue to decrease in the future. Previously, Zhao Heng predicted that the single price of covid-19 antigen detection products would fall between 5 and 10 yuan.
Zhao Heng also said that the purchasing subject of covid-19 antigen detection reagent should be mainly administrative units (including communities), which can be purchased and distributed to residents for use; At the retail level, more buyers should be groups that need to travel later to facilitate their self inspection in advance.
Shi lichen, founder of Beijing Dingchen Management Consulting Co., Ltd., believes that the average decline this time is still relatively large. After all, new products such as covid-19 antigen detection reagent have just been listed, but due to the comparison with nucleic acid detection (price), the decline is also within a reasonable range.
Shi lichen told China first finance and economics that the key question is whether the sales of covid-19 antigen detection reagents can be really raised under the rapid approval of the State Food and drug administration. "I don't think it's possible to have a high growth in the long term, but it will still form a certain market increment in the short term."
to meet the supervision requirements such as quality control
Industry insiders believe that relevant departments have prepared a comprehensive supervision system for the antigen detection market, which means that covid-19 antigen detection reagent needs to meet a series of requirements such as quality control and functional supervision on the basis of price reduction.
In this regard, Liang Jialin told reporters that, for example, in terms of quality supervision, the State Food and drug administration has issued a notice at the first time under the antigen detection scheme, instructing the provincial food and drug administration to strengthen post Listing Supervision and strictly investigate and deal with illegal acts such as unlicensed production and operation (such as illegal factories) and production and operation of unregistered antigen detection reagents [such as varieties not approved for listing in China (mainland)].
In terms of functional supervision, Liang Jialin said that since antigen detection is allowed to be used in home scenes and community scenes, it may leave room for inducing consumption and over inspection, "In particular, since those with positive self-test results may be diagnosed as positive in subsequent nucleic acid test results and face centralized isolation of individuals or families, it is necessary to prevent self-test persons from concealing and underreporting positive results, and formulate incentive and restraint policies in terms of actively reporting rewards and illegal concealment consequences."
In addition, Li Jinming, deputy director of the clinical testing center of the National Health Commission, also reminded at the press conference of the joint prevention and control mechanism of the State Council held on the 15th that in areas with low prevalence of covid-19 virus, antigen testing will detect more false positives. Therefore, it is suggested that the general population should not carry out antigen testing casually without similar symptoms of covid-19 pneumonia and relevant epidemiological sojourn history.
"At the same time, we should also prevent and curb the misuse of antigen testing, which is not only conducive to reducing the disease burden of residents, but also avoid the medical run caused by false positives." Liang Jialin said.
In addition to quality control and function supervision, what impact will price supervision have on enterprises? Liang Jialin said that the antigen reagent of Guangzhou Wondfo Biotech Co.Ltd(300482) of the head enterprise that had previously been selected in the centralized procurement of the alliance also took the initiative to apply for reducing the price of the successful selection to 9.8 yuan / person. Local medical insurance departments spent less than a week to intervene in the pricing of the original testing reagent, and the sudden huge profits in the nucleic acid testing industry are not expected to repeat.
enterprises still have profit margins
In the special centralized procurement of covid-19 virus antigen detection reagent of Lujin alliance, the quotation of 7.9 yuan / person of Bgi Genomics Co.Ltd(300676) subsidiary Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. attracted special attention. The outside world can't help asking, will there be room for enterprise profits with such a low quotation?
On March 17, the first financial reporter contacted Bgi Genomics Co.Ltd(300676) for confirmation and asked about the specific centralized purchase. As of the time of publication, no positive reply has been received. However, Bgi Genomics Co.Ltd(300676) told reporters that the company pays close attention to the bidding and procurement trends in various regions, promotes the market expansion of various channels, and helps to improve the accessibility of covid-19 antigen detection products. For the winning of centralized procurement, please refer to the results released by local official institutions.
At present, the retail prices of covid-19 antigen detection reagents on the market are mostly about 20 yuan to 30 yuan. The person in charge of a chain drugstore enterprise in China told China first finance and economics that the company recently ordered 500000 antigen detection kits from approved manufacturers, and the price is about 16 yuan. "Earlier, both sides had a game, and the subsequent specific price may fall again. After all, there are many approved enterprises, plus the price limit of centralized purchase."
In fact, the cost price of antigen detection reagent is not high. The relevant media quoted the data of securities companies to show that at present, the production cost of one person antigen self-test reagent in China is generally about 2 yuan to 4 yuan. In addition, due to the high proportion of self-produced raw materials, the cost may continue to be compressed.
"Now the centralized purchase prices reported by the approved production enterprises must have profit margins." Liu Gang (a pseudonym), R & D director of an antibody detection kit manufacturer, introduced to the first financial reporter from the perspective of production link.
Liu Gang's company is a large manufacturer of raw materials for covid-19 antigen detection kit in China. According to Liu Gang, the technologies used by the recently approved covid-19 antigen detection kit manufacturers are mainly colloidal gold method, fluorescence immunochromatography and latex method. "Antigen detection reagent products have a high maturity in the process Manufacturing in China, just like the early pregnancy detection reagents circulating in the market before. The whole process is relatively simple and the threshold is relatively low." The reporter found that among the 12 approved covid-19 antigen detection kit manufacturers, the number of products using colloidal gold method technology accounted for the highest.
Liu Gang told the first financial reporter that the main core raw material of covid-19 antigen detection kit is still antibody, that is, the immunoglobulin produced by the plasma cells proliferated and differentiated by B lymphocytes or memory cells under the stimulation of antigen and can specifically bind to the corresponding antigen, "The performance and quality of antibodies have a great impact on the sensitivity, specificity and other indicators of diagnostic reagents, as well as the overall performance and quality of diagnostic reagents."
China's leading enterprise producing antibodies to covid-19 antigen detection kit raw materials should belong to Feipeng biology, a giant of in vitro diagnostic reagent raw materials. Since the outbreak of covid-19 in 2020, as the core raw material supplier of molecular covid-19 test reagent and antigen antibody covid-19 test reagent, Feipeng biology has quickly responded to the market demand and rapidly developed a series of covid-19 virus related enzyme, antibody, antigen and other reagent raw materials and corresponding reagent products. It has been generally recognized by the market and purchased in large quantities by in vitro diagnostic reagent customers outside China. The demand is strong, and the relevant income has increased significantly.
According to the latest IPO prospectus disclosed by Feipeng biology on March 14, 2022, the company relies on the independently developed antibody technology platform and adopts advanced technologies such as immune technology, hybridoma technology, humanized antibody technology and cell fermentation technology to provide customers with high-quality antibody in vitro diagnostic reagent raw materials, including monoclonal antibody and polyclonal antibody.
Feipeng biological said that the company's antibody products are divided into monoclonal antibodies and polyclonal antibodies. Monoclonal antibodies are mainly produced by cell fermentation and mouse ascites, and polyclonal antibodies are mainly produced by rabbits and sheep.
"Among the antibody raw materials used in antibody kits on the market, monoclonal antibodies are used the most." Liu Gang said.
In 2018, 2019, 2020 and January to June 2021, the revenue contribution from antibody in the revenue of in vitro diagnostic reagent raw materials of Feipeng biology was 100 million yuan (accounting for 45.38% of the total revenue of the current year), 129 million yuan (accounting for 44.76% of the total revenue of the current year), 392 million yuan (accounting for 36.68% of the total revenue of the current year) and 765 million yuan (accounting for 69.39% of the total revenue of the current period).
The covid-19 antigen detection kit manufacturers Zhejiang Orient Gene Biotech Co.Ltd(688298) ( Zhejiang Orient Gene Biotech Co.Ltd(688298) . SH), Guangzhou Wondfo Biotech Co.Ltd(300482) ( Guangzhou Wondfo Biotech Co.Ltd(300482) . SZ), Beijing Hotgen Biotech Co.Ltd(688068) ( Beijing Hotgen Biotech Co.Ltd(688068) . SH) have purchased reagent raw materials and antibodies from Feipeng biology. According to the prospectus of Feipeng biology, in 2018, 2019 and January to June 2021, Guangzhou Wondfo Biotech Co.Ltd(300482) purchased 3.0166 million yuan, 8.6712 million yuan and 18.051 million yuan of antibody products from Feipeng biology. In 2020 and January to June 2021, Zhejiang Orient Gene Biotech Co.Ltd(688298) purchased 629219 million yuan and 252 million yuan of antibody products from Feipeng biology respectively.
In the past, covid-19 antigen detection kits produced by Chinese enterprises were mostly exported overseas. Feipeng biology said that most of the antibodies that account for the largest proportion of the company's covid-19 product revenue are directly sold abroad or finally sold abroad after being produced into antigen detection reagents by domestic customers.
Nowadays, under the background of multi-point outbreak of the epidemic in China and the "opening" of covid-19 antigen self-test products, the market prospect of covid-19 antigen detection kit products is optimistic by the industry.
According to the prospectus of Feipeng biology, the antibody of the company's products is mainly priced in "mg". In 2018, 2019, 2020 and January June 2021, the sales price of antibody per mg gradually increased, reaching 30.30 yuan / Mg, 38.29 yuan / Mg, 71.87 yuan / Mg and 116.09 yuan / mg respectively.
"In the production and manufacturing process, in addition to the raw materials and antibodies used, some auxiliary materials will be used, plus labor costs." Liu Gang said that the manufacturing cost will not be too high. The approved manufacturer Huada Yinyuan told first finance that the main components of the antigen detection kit include detection card, sample extraction solution and sample extraction tube.
