"Is Chinese Research Trustworthy?"... US FDA Halts Approval of China-Developed New Drugs

Published 10 Feb.2022 07:27(KST)

Updated 10 Feb.2022 09:27(KST)

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Hyunjung] The United States has put the brakes on the approval of dozens of cancer treatments and new drugs developed in China. Regulatory authorities have expressed doubts about whether the research results, including clinical trials conducted in China, can be applied to American patients, raising concerns about their reliability.

The Wall Street Journal (WSJ) reported on the 9th (local time) that the U.S. Food and Drug Administration (FDA), which is responsible for drug safety management, expressed concerns about pharmaceutical companies conducting clinical trials in China for new drug development.

This move threatens to halt the plans of Western pharmaceutical companies such as Eli Lilly, Novartis, and AG NVS, which were aiming for billions of dollars in sales through the import of Chinese pharmaceuticals into the U.S. Eli Lilly planned to launch a lung cancer treatment developed in China this year and sell it at a lower price than similar drugs currently on the market.

The FDA raised concerns primarily about whether the clinical trials were properly conducted in China and whether, even if the clinical results are accurate, they can be directly applied to Americans. According to the British Medical Journal (BMJ), 80% of the Chinese drug application data submitted to the Chinese drug regulatory agency in 2016 showed issues such as manipulation, defects, or insufficiency.

Richard Pazdur, head of cancer drugs at the FDA, questioned the reliability of clinical trials in China, stating, "We are not opposing drugs developed in China, but rather questioning whether the clinical results can be applied in the U.S. as well."

Some in the pharmaceutical industry believe that Chinese biotech companies and their Western partners may conduct additional testing of the proposed new drugs on American patients.

Previously, in 2019, the FDA approved BeiGene's lymphoma treatment Brukinsa. Most of the clinical trial participants leading to the approval were in China, with some in the U.S.