HLB's efforts to secure FDA approval for its liver cancer drug have hit another snag. Quality control issues at the manufacturing facility of its co-developer have prevented the company from overcoming the approval hurdle for the third time.
On July 9, HLB's U.S. subsidiary Elevate Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for the drug riboceranib.
Riboceranib has been developed as a treatment for liver cancer in combination with the immuno-oncology drug camrelizumab from China's Jiangsu Hengrui Medicine.
In the CRL, the FDA indicated that while there were no direct issues with the clinical data for riboceranib itself, concerns were raised during the cGMP inspection of the manufacturing facility included in the NDA, leading to the issuance of Form 483. This form notifies companies of necessary improvements identified during FDA inspections.
The FDA stated that approval cannot be granted until the identified issues at the manufacturing facility are resolved in a timely manner and compliance with cGMP standards is confirmed. Additionally, a Pre-Approval Inspection (PAI) may be conducted if necessary, and both cGMP inspection and PAI must be satisfied for final approval.
The facility in question received a Form 483 following a routine cGMP inspection in April and is currently undergoing corrective actions. The final inspection rating has yet to be determined.
According to the company, this facility was inspected by the FDA for the first time in about eight years, having received four 'No Action Indicated' (NAI) ratings and one 'Voluntary Action Indicated' (VAI) rating in its previous five inspections since 2018.
HLB explained that since this inspection was a routine cGMP audit rather than a PAI for approval, Elevate and HLB were not informed in advance about the issuance of Form 483.
Immediately after receiving the CRL, Elevate officially requested details of Form 483, FDA response materials, and a timeline for corrections from Jiangsu Hengrui. The company plans to review the related materials and consult with the FDA before proceeding with the resubmission process.
Kim Dong-geon, CEO of Elevate, stated, "The CRL did not include any concerns regarding clinical efficacy or safety data, nor did it require additional clinical trials. We will promptly address the cGMP-related issues at the manufacturing facility and aim to resubmit as soon as possible."
Meanwhile, HLB's stock has plummeted, trading at a lower limit immediately after the market opened. As of 9:37 a.m., HLB was trading at 36,600 won, down 15,600 won (29.89%) from the previous trading day.
* This article has been translated by AI.
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