HLB Fails Anticancer Drug Approval, "FDA May Have Been Unable to Conduct Clinical Inspection Due to Lack of Funds"

Hangseong Pharmaceutical, "CMC Issue Is a Problem with Some Facilities"
HLB, "Resubmission Timing Will Be Decided After Meeting with FDA"

HLB claimed that the failure of the U.S. Food and Drug Administration (FDA) approval for its anticancer drug, Rivoceranib, may be due to the FDA's budget constraints.

Han Yonghae, CTO of HLB Group; Frank Jiang, Vice President of Hansoh Pharmaceutical, China; Jeong Seho, CEO of Elevate Therapeutics; Jang Seonghun, Vice President of Elevate Therapeutics (from left) attending a press conference held during the HLB Bio Forum in Songpa-gu, Seoul on the 23rd.
[Photo by Lee Chunhee]

On the morning of the 23rd, at the HLB Bio Forum held in Songpa-gu, Seoul, Jeong Se-ho, CEO of Elevate Therapeutics, stated, "The reason why the Bioresearch Monitoring Program (BIMO) inspection was not conducted could be because the FDA lacks the resources or budget to carry out on-site inspections." He added, "Although it is currently assumed that the places where BIMO was not conducted are Russia or Ukraine, it is not because they could not go due to the war, but possibly because the FDA did not have the funds to go."

Elevate is HLB's U.S. subsidiary that has been working on obtaining FDA approval for Rivoceranib and the combination drug Camrelizumab. This combination therapy was scheduled for an FDA decision on liver cancer treatment approval on the 16th. However, HLB failed to obtain approval and received a Complete Response Letter (CRL) from the FDA. The CRL pointed out issues including ▲lack of BIMO inspection at some clinical sites ▲problems related to the Chemistry, Manufacturing, and Controls (CMC) of Camrelizumab production by Hansoh Pharmaceutical.

HLB and Hansoh Pharmaceutical claimed, "There were no issues in other BIMO inspections, and only some clinical sites were not inspected." Frank Jiang, Vice President of Hansoh Pharmaceutical, said, "Hansoh Pharmaceutical, the Contract Research Organization (CRO) IQVIA, and the Harbin Medical University Cancer Hospital in China, which had the most patients participating, all received a 'No Action Indicated (NAI)' rating," adding, "There have been no problems in BIMO inspections so far." CEO Jeong commented on the BIMO issue, saying, "There are ways to conduct virtual inspections without the FDA visiting clinical sites directly, and alternative data submissions can be proposed," and added, "We will listen to explanations through a meeting with the FDA as soon as possible."

Regarding the more fundamental CMC issue pointed out in this approval failure, HLB stated, "We have not yet identified the problem and need to monitor the situation." CEO Jeong explained, "Any facility receives comments during the inspection process. Hansoh Pharmaceutical was no different, and no problematic ratings were issued." However, Vice President Jiang repeatedly insisted that this matter was due to issues with some 'facilities.'

HLB asserted, "This CRL is unrelated to the drug's efficacy and safety." Han Yong-hae, Chief Technology Officer (CTO) of HLB Group, claimed, "The evaluation of efficacy and safety was completed without any remarks," and added, "There are cases like ours where a CRL is issued related to CMC, and in such cases, it typically takes an additional 6.7 months on average to obtain approval." Regarding the timing of reapplication, CEO Jeong said, "We have requested a meeting with the FDA," and added, "After confirming the issues through the meeting, we will decide on the timeline for resubmission and other steps."