HLB's shares surged after the company announced that issues related to its manufacturing facilities for the liver cancer drug Riboceranib have been resolved in the U.S. Food and Drug Administration (FDA) approval process.
As of 9:09 a.m. on July 15, HLB's stock was trading at 34,700 won, up 29.96% (8,000 won) from the previous trading day, according to the Korea Exchange.
The company stated that its U.S. subsidiary, Elevate Therapeutics, received a Close-out Letter from its Chinese partner, Jiangsu Hengrui Medicine, indicating the completion of the FDA's inspection of the manufacturing site for Riboceranib active pharmaceutical ingredients under current Good Manufacturing Practice (cGMP) standards.
According to HLB, the FDA determined that the facility generally complies with current drug manufacturing and quality control standards and classified the inspection results as a Voluntary Action Indicated (VAI).
However, the FDA clarified that the classification of VAI does not affect the evaluation of the ongoing approval application.
Previously, on July 10, HLB received a third Complete Response Letter (CRL) from the FDA regarding the combination therapy of Riboceranib and Camrelizumab, which is being developed as a first-line treatment for liver cancer. The CRL was reportedly related to issues identified during the inspection of Jiangsu Hengrui's manufacturing facilities.
Jiangsu Hengrui is expected to submit its response to the FDA's request for additional information and a corrective and preventive action plan by July 24. HLB plans to resume the new drug approval process promptly after discussions with the FDA.
* This article has been translated by AI.
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