On April 17, Kehua Biological (002022.SZ) announced yesterday that a chemiluminescence reagent obtained a medical device registration certificate. Kehua Bio is a leading integrated IVD enterprise in China, and the chemiluminescence product line is the key development direction of the company. However, it is worth noting that since chemiluminescence is a fully enclosed system, the instrument can only use the matching reagents, so it is still necessary to obtain the company's chemical luminescence instrument before it can be sold.

In this regard, Kehua Biological Company told the Great Wisdom News Agency that the company's chemical luminescence instruments have been declared for production and are expected to be approved for listing at the end of this year or next year.

According to public information, chemiluminescence is a medium-to-high-end IVD product. Compared with domestically mature enzymes, R&D thresholds and terminal pricing are higher. The biggest attraction of the industry lies in the replacement of traditional enzyme-free diagnostic technology.

At present, imported products are in a dominant position in the field of chemiluminescence. Foreign brands such as Roche, Abbott and Beckman occupy a large market share, while domestic enterprises are still in the initial stage in the field of chemiluminescence. The existing products include Beijing Kemei and Shenzhen. The new industry and Sichuan Mike have a market share of 10-15% for individual companies.

Li Aman (300298.SZ), another A-share listed company, has obtained 31 certificates for the registration of chemiluminescence reagents as of the end of 2013. However, since the company's chemiluminescence instrument was put into the market this year, the business has not contributed to the company.

According to a brokerage analyst, from the current market situation, the competition pattern of chemiluminescence is not fierce. If Kehua Biotech's instruments can be put into the market as soon as possible, there is still a large market space. “The premise is that the instrument is approved as early as possible and can guarantee stability.”