HLB's (028300) combination therapy of rivoceranib and camrelizumab, a new liver cancer drug under development, has once again failed to clear the U.S. Food and Drug Administration (FDA) approval hurdle. The FDA issued a third Complete Response Letter (CRL). The letter was communicated to HLB's U.S. subsidiary, Elevar Therapeutics, on the 9th local time.

Following the news, HLB's stock price plunged to the daily lower limit of 36,600 won during the afternoon trading session on the 10th. Investors' disappointment was fully reflected in the share price.

Third CRL, Cause Once Again 'Manufacturing Facility'

The reason for this request for additional information is not related to the efficacy or safety of the drug itself. The key issue is that deficiencies were identified during a cGMP (current Good Manufacturing Practice) on-site inspection of the manufacturing facility of China's Jiangsu Hengrui Pharmaceuticals, which produces camrelizumab, the combination therapy partner. The FDA's position is that it will withhold approval until the facility corrects the identified deficiencies and cGMP compliance is confirmed.

The fact that the same pattern is repeating is fueling market concerns. The same combination therapy received CRLs from the FDA in 2024 and 2025, and both cases were caused by requests for additional information related to Hengrui Pharma's manufacturing facility rather than clinical data or drug safety. With this latest instance, the same type of manufacturing issue has become an obstacle to new drug approval for the third consecutive time.

PDUFA Deadline is July 23

This review was conducted under the Prescription Drug User Fee Act (PDUFA), with July 23 as the final decision deadline. Elevar Therapeutics confirmed that the inspection findings are directly tied to the approval review and has officially requested relevant data from Hengrui Pharma. The company stated that it will promptly address the issues and then proceed with the resubmission process to the FDA.

Next Key Focus: September Cholangiocarcinoma Review

Investors' reactions are particularly intense because this is the 'third' occurrence. Disappointment has been amplified given that this outcome comes after overcoming two previous failures and mounting another challenge.

In addition to this liver cancer treatment, the HLB Group is also awaiting the FDA's decision on litifuginib, a cholangiocarcinoma (bile duct cancer) treatment candidate, in September. The impact of this CRL on the group's overall approval roadmap is cited as the next key point to watch.

However, some in the industry caution against excessive pessimism. Based on statistics showing that the majority of CRLs issued by the FDA stem from manufacturing and quality control (CMC) issues rather than clinical data defects, they argue that the possibility of approval remains once the production facility issues are resolved.

[This article is for reference in making investment decisions, and the final responsibility for investments lies with the investor. This article was written with the assistance of AI.]