HLB ‘FDA meeting complete...no supplement data required'

FDA requested no additional supplemental data regarding the CRL

HLB’s U.S. subsidiary Eleva and Jiangsu Hengrui Pharmaceuticals hold follow-up meeting regarding the receipt of the CRL

"Has faithfully submitted the required supplemental data...FDA recommended the company submit an application for reexamination"

HLB announced on the 2nd that it had completed the meeting with the U.S.

 

Food and Drug Administration (FDA) to resume the license review of its new liver cancer drug.

 

At the meeting, which was attended by HLB's US subsidiary Eleva and Chinese partner Jiangsu Hengrui Pharmaceuticals, the FDA said it "strongly recommends submitting a re-examination application" to expedite the main review, which was delayed due to the issuance of the complete response letter (CRL), and delivered an official Post Action Letter (PAL) along its position.

 

HLB is interpreting the letter as meaning that "no additional supplementary information will be requested as Jiangsu Hengrui Pharmaceuticals has already faithfully submitted supplementary data regarding the points raised after the CMC on-site inspection visit in December for camrelizumab, which is used in combination with rivoceranib, a new drug for liver cancer." In May, HLB announced that it had received a CRL from the FDA regarding the application submitted requesting the approval of the combination therapy rivoceranib and Jiangsu Hengrui Pharmaceuticals’ immune-oncology drug camrelizumab as a first-line treatment for liver cancer.

 

The primary reason for the CRL was reportedly due to a BIMO (Bioresearch Monitoring) finding, which identified the manufacturing facility and key clinical sites for camrelizumab.

 

At the time, the company explained that the CRL was due to a facility issue.

 

Regarding BIMO on-site inspection, the FDA said that "the BIMO was not the primary reason for issuing the CRL.

 

The BIMO will be conducted during the re-examination period upon submission of the documentation." Now that the uncertainty surrounding the liver cancer drug has been removed, HLB plans to focus on completing the remaining steps for its global approval.

 

Yong-Hae Han, CTO of HLB, said, “We were assured by Jiangsu Hengrui Pharmaceuticals that they have already submitted sufficient supplementary documents to address the FDA's points, so we plan to fully prepare and submit our request for re-examination as soon as possible.

 

Although our plan was somewhat delayed than scheduled, it was an opportunity for us to conduct a complete inspection of the production plant to enhance the external credibility of our product quality, and were able to officially reflect the superior data of our new liver cancer drug to the application.

 

We expected these changes to have a positive effect in the future."