[Edaily Reporter KIM SAE-MI ] HLB INC.(028300)announced on the 15th that the U.S. Food and Drug Administration (FDA) inspection of the active pharmaceutical ingredient (API) manufacturing facility for the new liver cancer drug Riboceranib, conducted under Current Good Manufacturing Practice (cGMP) standards, was concluded with a “Voluntary Action Item” (VAI).
HLB’s U.S. subsidiary, Eleva Therapeutics, received a Seohan on the 14th (local time) from its partner, Hangzhou Pharmaceutical, confirming the conclusion of the FDA’s inspection of the riboceranib API manufacturing facility.
A VAI is a classification issued when the FDA identifies issues during an inspection but determines that they do not currently warrant administrative or regulatory action, and that voluntary corrective action by the company is necessary.
According to HLB INC., the FDA explicitly stated in the Seohan that the VAI classification itself does not directly affect the evaluation of any ongoing marketing authorization applications associated with the facility in question.
HLB INC. plans to submit an official inquiry to the FDA to determine the impact of this inspection result on the Complete Response Letter (CRL) for the riboceranib and camrelizumab combination therapy. The company intends to pursue this inquiry through a more expedited process, separate from the Type A meeting held to discuss the approval process following the CRL.
However, the corrective action process related to the finished drug product (DP) manufacturing facility is still ongoing. A Form 483 detailing the FDA’s inspection findings was also issued for that facility, and Hangzhou Pharmaceutical is scheduled to submit a response and a Corrective and Preventive Action (CAPA) plan by the 24th (local time).
HLB INC. maintains that the findings regarding the DP manufacturing facility fall into a similar category to those of the active pharmaceutical ingredient (API) manufacturing facility. The specific findings and the FDA’s final facility classification have not been disclosed.
HLB INC. officials stated, “We understand that the corrective actions required regarding camrelizumab in the previous CRL have been reviewed and concluded without any particular issues,” adding, “Since the inspection of the API manufacturing facility was also concluded with a VAI, we will promptly consult with the FDA to resume the approval process.”
The official added, “We will formally confirm with the FDA how this outcome affects the grounds for the CRL and will respond without delay to the remaining corrective actions required for the finished drug product manufacturing facility.”
