During the reporting period, due to unqualified product sampling, the problem of Product Quality wovent was concerned

Recently, Sichuan Wovent Biological Engineering Co., Ltd. (hereinafter referred to as "Wovent") updated the GEM IPO prospectus and inquiry response. The "Economic Information Daily" reporter noted that during the reporting period (referring to 2018, 2019, 2020 and January to June 2021, the same below), The overall growth of Wovent performance was stable, but the product had been notified by the relevant departments due to unqualified sampling.

According to the prospectus, Wovent is mainly engaged in the research and development, production and sales of in vitro diagnostic instruments, reagents and consumables, as well as the agency business of non-self-produced in vitro diagnostic products, and is an innovative enterprise dedicated to providing automated testing solutions and diagnostic products for medical testing.

During the reporting period, The overall performance of Wovent remained stable, with operating income of 276.3211 million yuan, 386.5630 million yuan, 378.8405 million yuan and 219.8069 million yuan, respectively, and net profit of 39.0163 million yuan, 66.4894 million yuan, 53.2305 million yuan and 37.2505 million yuan, respectively. Among them, revenue and net profit in 2020 have declined slightly.

It is worth noting that while the performance has grown steadily, Wovent has been notified by the relevant competent authorities many times during the reporting period due to unqualified sampling inspections. According to the prospectus, on May 22, 2020, the Notice of the State Food and Drug Administration on Issuing the Results of the National Medical Device Supervision and Sampling Test (No. 2) (No. 34 of 2020) showed that the 1 batch of glucose measurement kits produced by Sichuan Wovent Biotechnology Co., Ltd. (hereinafter referred to as "Wovent Technology"), a subsidiary of Wovent, did not meet the standards. Subsequently, Wovent Technology conducted a risk assessment of the batch of products, believing that the reason was mainly due to compatibility problems after the customer replaced the reagent bottles themselves.

From June 8 to 9, 2020, the Sichuan Provincial Drug Administration conducted a medical device flight inspection of Wovent technology, and on August 17, 2020, it issued the "Announcement of sichuan Provincial Drug Administration on the Flight Inspection of Medical Devices in the First Half of 2020" (No. 13 [2020]), which pointed out that the inspection results of Wovent technology were rectified within a limited period of time, and the rectification matters were mainly aimed at the standardization and optimization of the basic operation links in the company's production process.

It is worth mentioning that the Shenzhen Stock Exchange is also concerned about the sampling of Wovent subsidiaries, requiring the company to disclose the return and replacement of products and explain whether the company's internal control measures for product quality are effective. In this regard, Wovent said that the amount of returns and exchanges that occurred during the reporting period of the company and its subsidiaries accounted for a relatively small proportion, most of which were returned and exchanged due to the adjustment of the procurement needs of some customers, and the company handled the return and exchange procedures for this part of the customers based on the consideration of long-term cooperation.

In view of the internal control of product quality, Wovent said that the company has formulated corresponding systems in the procurement link, production link and sales link, such as the "Product Return and Recall Management System" to return and replace the delivered products that meet the conditions for return and exchange, the products that meet the conditions for recall are recalled, the return or recall caused by quality problems is evaluated for product defects, and the product defects are eliminated by warning, repair, update or destruction as appropriate.

Author: □ reporter Li Ben reported from Beijing

Source: Economic Reference