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NetEase Finance July 17threcently,Hengrui Medicineone placepreparationThe production site receivedUSAThe Food and Drug Administration (FDA)Warning LetterThis warning letter is a follow-up measure to the results of the FDA's inspection of the pharmaceutical production site at No. 38 Huanghe Road, Lianyungang Economic and Technological Development Zone from January 8 to January 16, 2024. This site is the earliest built site under Hengrui's international pharmaceutical production base.

This warning letter lists two defects, which are basically derived from some of the contents listed in the last 483: the quality control department did not perform its duties in document supervision and control adequately, and failed to ensure that the preparations produced met CGMP requirements; the facility design was inadequate, and the areas used to produce sterile products did not have adequate measures to prevent contamination or confusion.

Hengrui Medicine told NetEase Finance that the company attaches great importance to the opinions raised by the drug regulatory agency during the inspection. In response to the improvement suggestions put forward by the FDA in this warning letter, the company will actively organize internal and external experts and third-party consulting agencies to implement the relevant suggestions, and maintain close communication with the FDA to try to close the warning letter as soon as possible.

In response to the product quality issues that have attracted widespread concern from the outside world, Hengrui Medicine said that the company has conducted a comprehensive investigation and assessment, and the issues pointed out in this FDA warning letter have not affected the quality and safety of the drugs.So far, the companyThe export of products from this site was not affected.

It is expected that this warning letter will not have a significant impact on the company's 2024 performance.Hengrui Medicine also mentioned that the site has a total of 12Generic DrugsThe varieties have obtained FDA marketing approval, but they are not the company's main products. The site's revenue from exports to the US market in 2023 was US$12.4 million, accounting for approximately 0.39% of the company's operating income in 2023; the site's revenue from exports to the US market in the first quarter of 2024 was US$3.9388 million (unaudited), accounting for approximately 0.47% of the company's current operating income.

Finally, Hengrui Medicine also emphasized thatThis warning letter has no impact on the company's other production sites, and the company's products currently exported to the United States are also not affected.

Industry insiders believe that Chinese pharmaceutical companies may face stricter supervision when going overseas in the future. Companies need to not only strictly control the quality of their own products, but also pay attention to changes in the regulatory environment of the target market. The Hengrui incident can serve as a reminder to the industry that companies need to pay more attention to production sites with a long history, and workshop design and equipment facilities need to be re-evaluated in accordance with the latest regulatory requirements to continuously improve their adaptability and compliance.