(Yicai) March 24 -- Shares in Jiangsu Hengrui Pharmaceuticals slumped today after the Chinese drugmaker’s new cancer medicine failed for the second time to get the greenlight in the US. Hengrui vowed to take swift corrective action and to reapply as soon as the issues were resolved.

The news raised concerns about the drug’s US market prospects, affecting the company’s stock price. Hengrui’s share price [SHA: 600276] closed down 1.1 percent at CNY44.35 (USD6.12).

Hengrui has received a Complete Response Letter from the US Food and Drug Administration regarding its Biologics License Application for the combination of its PD-1 inhibitor Camrelizumab and its VEGFR-2 inhibitor apatinib as a first-line treatment for liver cancer, the Liangyungang-based company said on March 22.

A Complete Response Letter is a regulatory action indicating that the FDA's review is complete but that the application did not meet the required standards, the firm said. In the letter, the FDA cited unresolved issues in the inspection of production facilities but did not provide specific details. If the applicant can address these concerns within the set time, a Complete Response Letter usually does not affect the final outcome, it added.

In May 2024, Hengrui received its first Complete Response Letter for the same drug. The FDA cited at the time some inadequacies in its manufacturing process and travel restrictions in certain countries. This prevented the Maryland-based authority from completing the necessary Biological Research Monitoring Program inspections and as a result the application could not be approved within the designated timeframe.

In October last year, Hengrui resubmitted the Biologics License Application for the liver cancer treatment and it was accepted by the FDA.

Hengrui’s factory was inspected by the FDA in January, it said. The FDA confirmed that issues found during the first inspection had been resolved, but raised three new requests for improvement.

Hengrui said it will respond to these requests within the required timeframe and will resubmit the application as soon as it clarifies the specific issues behind the FDA’s concerns, so as to secure the greenlight next time.

Editor: Kim Taylor