The raw material on the antigen detection kit is out of stock. Some suppliers say they can wait as soon as three months

"The spot is definitely gone. The shortest scheduling period is three or four months" and "it is expected to be available in July and August". Recently, when the new longitude and latitude sent electricity to some NC membrane suppliers, most suppliers said that due to the epidemic, NC membrane has no spot and needs to be scheduled.

The so-called NC membrane is one of the necessary raw materials for antigen detection kit. It is used as the carrier of C / T line in colloidal gold test paper. At the same time, it is also the place where immune reaction occurs. It is one of the most important consumables in biological experiments.

Why is NC film in short supply? How should relevant listed companies respond?

in stock: three or four months at the earliest

According to the list provided by the supplier to Zhongxin Jingwei, the raw materials of antigen self-test reagent mainly include NC membrane, binding pad, colloidal gold synthesis, fluorescent microspheres, descaling agent, sealing agent, polymer, crosslinking agent, quenching agent, buffer, active and passive blockers, secondary antibodies and lysate. Among them, only NC membrane needs to be scheduled.

The dealer can't wait until the beginning of September, but the NC has to wait until the third month of the year. The dealer said that the new warp film is out of stock. However, the customer has to wait so long since August.

A domestic NC film manufacturer told Zhongxin Jingwei that they have NC films in stock, but they are not sold in rolls, but sold by sheet, with 2 films of 180 yuan, 5 films of 390 yuan, 10 films of 630 yuan and 20 films of 1050 yuan.

Wang Shuai (a pseudonym), another agent of imported NC membrane, told Zhongxin Jingwei that the NC membrane market is now mixed. According to the information he learned, the antigen detection kit needs a backing, followed by the caliber requirements. On the other hand, NC membrane mainly depends on import. Under the epidemic, the import of NC membrane is blocked, and some manufacturers also start OEM. "I can only say that if it is authentic imported goods, now the price is 10000 yuan, and one roll can't be bought. In the past, it was only two or three thousand ." Wang Shuai said.

According to the information of the State Food and drug administration, as of March 24, antigen detection kits produced by 19 enterprises had been approved, of which 13 enterprises were produced by colloidal gold method; The production process of 3 enterprises is fluorescence immunochromatography; The production process of three enterprises is emulsion method.

At the same time, on March 21, the office of the National Medical Insurance Bureau issued the notice on effectively doing a good job in the current epidemic prevention and control medical security, which said that covid-19 virus antigen detection reagent should be temporarily included in the catalogue of basic medical insurance medical services in the province.

According to incomplete statistics, Guangdong Province, Anhui Province and other places have issued relevant plans or centralized collection of antigen detection kits. Previously, the results of the special centralized procurement of covid-19 virus antigen detection reagent of Lujin alliance were released, and 5 of the 11 enterprises were selected, promising a total of 2010 million people per day.

Under medical insurance and centralized collection, antigen detection reagents may usher in a large amount. According to the analysis of Minsheng Securities Research Report, with the normalization of covid-19 pneumonia epidemic, covid-19 home self inspection is expected to be popularized nationwide. Assuming that the ex factory price of the product is 6-10 yuan / person, and the median value is 30% based on the penetration range of 10% - 50%, the corresponding market space for covid-19 antigen detection in China is 20.16-33.6 billion yuan per month. How can the approved enterprise deal with the possible shortage of NC film?

several enterprises said they would increase production capacity

Asahi bio is a biological raw material technology platform with independent R & D and production of antigen and antibody. According to the listing announcement, Asahi bio covid-19 virus detection reagent (immunochromatography) has been sold to overseas markets since March 2020, and the cumulative sales revenue by the end of 2020 is 986 million yuan.

According to the previous institutional research form of Anxi biology, Anxi biology said that at present, the monthly production capacity of covid-19 test box is about 260 million people, and the monthly production capacity of covid-19 test pen is expected to be about 50 million people. It also said that in the process of expanding production capacity, problems such as recruitment difficulties have been solved, and the factors that may affect the expansion of production capacity will be the supply of NC membrane. At present, there are about 4-5 foreign manufacturers cooperating with NC film manufacturers. Chinese manufacturers have some old brands and some new brands, which can meet the supply, but an Xu biology said that it will always maintain a certain vigilance. In the future, some high-quality suppliers may be cultivated to meet product requirements.

According to the annual report of Zhejiang Orient Gene Biotech Co.Ltd(688298) 2021, the annual revenue was 10.032 billion yuan, deducting the net profit not attributable to the parent company of 4.761 billion yuan, an increase of 187.1% over the previous year Zhejiang Orient Gene Biotech Co.Ltd(688298) said in its annual report that sales of New Coronavirus antigen rapid test reagent (including home self testing) products in Europe increased significantly in 2021.

According to Zhejiang Orient Gene Biotech Co.Ltd(688298) official wechat, at present, the company's covid-19 antigen detection reagent has a daily production capacity of about 18 million people. On the premise of ensuring technical indicators and product quality, the company will further improve the supporting capacity of production capacity, try its best to ensure the detection demand at home and abroad, and give priority to meeting the needs of the government in centralized procurement and residents' antigen self-detection.

On the 21st, Guangzhou Wondfo Biotech Co.Ltd(300482) in response to investors' questions about production capacity on the investor interaction platform, said that the company would dynamically adjust production capacity according to business strategy, market conditions and other factors. At present, the company's production capacity can meet the normal delivery of orders, and will continue to effectively plan production capacity according to market demand.

The production capacity of the other party is normal, and the new party has the corresponding production capacity.

why is there a shortage of nc film

Referring to the reasons for the shortage of NC membrane, several suppliers agreed that under the influence of the epidemic, on the one hand, the amount of antigen detection boxes required by the international epidemic has increased sharply, and many Chinese manufacturers participate in foreign exports; On the other hand, in the production of antigen detection kit, NC membrane mainly depends on import, and the epidemic situation will affect the import and export of NC membrane.

At the same time, it should not be ignored that according to the public information, the shelf life of NC membrane is only one year and needs to be sealed and stored in 5-15. Therefore, NC membrane does not support saturated storage.

Zhongxin Jingwei noted that Beijing Hotgen Biotech Co.Ltd(688068) in the listing announcement, it said that although there are other manufacturers in the market for key raw materials such as photomultiplier tubes and NC films, the company's product R & D and production process are well matched with the products of Binsong Photonics and Merck chemical. Therefore, the company has the risk that some key raw materials depend on import and price rise to a certain extent.

Previously, Zhejiang Orient Gene Biotech Co.Ltd(688298) on the investor interaction platform also said that the company has always attached importance to the principle of product quality first and mainly used NC membrane imported from Germany.

According to the semi annual report of Zhejiang Orient Gene Biotech Co.Ltd(688298) 2021, as a whole, the in vitro diagnosis industry has high technical threshold, high access threshold, long development time and high investment amount. The bottleneck of the industry is fierce competition, and some core technologies are still monopolized and controlled by foreign enterprises.

At the same time, Zhejiang Orient Gene Biotech Co.Ltd(688298) said that at present, the most difficult detection technology threshold in the in vitro diagnosis industry is how to better improve the accuracy (including specificity and sensitivity), convenience and time efficiency of detection. POCT rapid diagnostic reagents, such as the company's colloidal gold method, the biggest technical bottleneck is the biological raw materials of antigens and antibodies in the upstream of the industry. If they rely on outsourcing, the product technical indicators and core elements of quality cannot be well controlled.

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