HLB announced that it has addressed many of the key issues that led to the U.S. approval delay of its liver cancer drug.
On July 14, HLB reported that its U.S. subsidiary, Elevate Therapeutics, received a letter from its partner, Anhui Zhifei Longcom Biopharmaceutical, confirming the completion of the FDA's cGMP inspection of the raw material manufacturing facility for riboceranib. According to HLB, the FDA classified the inspection results as a Voluntary Action Indicated (VAI).
The letter reportedly stated that the VAI classification does not affect the FDA's evaluation of the ongoing approval application associated with the manufacturing facility.
Previously, the FDA had cited the results of the cGMP inspection at the Anhui Zhifei Longcom site as a reason for issuing a Complete Response Letter (CRL) regarding the liver cancer drug. Elevate plans to conduct a more expedited official inquiry with the FDA, in addition to a Type A meeting.
It is also reported that Form 483 for the finished drug manufacturing facility included similar issues as those found at the raw material manufacturing facility. Anhui Zhifei Longcom is expected to submit a response and corrective and preventive action (CAPA) plan to the FDA by July 24 (U.S. time).
A company official stated, "The FDA has concluded its review of the supplemental requirements related to camrelizumab without any special issues in the last CRL. With the cGMP inspection of the raw material manufacturing facility now classified as VAI, we believe that most of the key issues that affected the approval process have been resolved." The official added, "We will work quickly with the FDA to resume the new drug approval process as soon as possible."
In 2023, HLB applied for FDA approval of riboceranib in combination with Anhui Zhifei Longcom's immuno-oncology drug, camrelizumab, as a first-line treatment for liver cancer. However, in 2024, Anhui Zhifei Longcom received a CRL from the FDA, leading to the denial of approval. A second application was also rejected last year due to issues related to sterilization procedures.
* This article has been translated by AI.
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