(Yicai Global) May 31 -- Shares in Lepu Medical Technology slumped as much as 6.5 percent today despite the Chinese hi-tech medical device maker saying that the US recall of two of its Covid-19 test kits has barely any impact as the company stopped supplying antigen reagents to the US in June last year.
The company’s stock price [SHE:300003] was trading down 4.59 percent at CNY32.39 (USD5) at 1:30 p.m. China time today. Earlier in the day it had dropped to CNY31.74.
The US Food and Drug Administration launched a recall on May 28 of a SARS-CoV-2 antigen rapid test kit and antibody rapid test kit manufactured by Beijing-based Lepu, claiming that “there is a high risk of false results.”
Covering all kits manufactured and distributed since March 20, 2020, US customs calculates this to be 8.4 million units. Yet Lepu said yesterday that this figure includes test kits sent to South American countries via the US, and only 460,000 of these entered the US, the Securities Times reported, citing the firm.
The company is investigating the products that entered the US market and is actively cooperating with the FDA to verify the inventory of all distributors and complete the product recall in accordance with US law, the report said.
Lepu stopped selling its antibody kits to the US in June last year, after the products were dropped from the FDA’s Notification List of approved antibody tests on June 19 last year, it said.
Since then, the company has never applied for registration of its antigen test reagents in the US nor attempted to sell them in the country. Thus, the recall has basically no impact on Lepu, it added.
Lepu’s net profit surged 89.2 percent in the first quarter from the same period last year to CNY726 million (USD114 million). Revenue was up 65 percent to CNY2.7 billion (USD432.1 million).
Editor: Kim Taylor