HLB Seeks FDA Approval for Cancer Drug Liraglutide Amid Challenges

HLB is awaiting the U.S. Food and Drug Administration's (FDA) decision on its cholangiocarcinoma treatment, Liraglutide, by the end of this month. Following three complete response letters (CRLs) for its liver cancer drug, investor confidence has been shaken, making this approval review a critical test of HLB's drug development capabilities.

According to the pharmaceutical and biotech industry on September 5, the FDA's review deadline for HLB's U.S. subsidiary Elevate Therapeutics' New Drug Application (NDA) for Liraglutide is September 27. Liraglutide is being evaluated as a second-line treatment for patients with advanced cholangiocarcinoma who have FGFR2 gene fusions or rearrangements.

In July, HLB completed a late-cycle meeting with the FDA, which is a procedure where the FDA and the applicant discuss post-approval commitments and other matters before the review concludes. It is reported that the meeting primarily addressed post-marketing requirements (PMR) and post-marketing commitments (PMC). Notably, the company stated that no new issues or red flags that could significantly impact the approval decision were raised during this meeting.

The heightened market interest stems from HLB's recent setbacks in its liver cancer drug approval attempts. In July, HLB received its third CRL for the combination therapy of Riboceranib and Camrelizumab, which was being developed as a first-line treatment for liver cancer. The FDA cited the need for additional information regarding the manufacturing and quality control standards (cGMP) at the facilities of China's Jiangsu Hengrui Medicine. HLB clarified that there were no concerns regarding clinical efficacy or safety data, but the repeated delays have weighed on the company's drug development timeline and investor sentiment.

If Liraglutide secures FDA approval, it could alleviate some of the uncertainties stemming from the delays in liver cancer drug approvals for HLB. This would also mark a significant milestone as it could be the first instance of a domestic pharmaceutical and biotech company receiving FDA approval for an oncology product.

Industry experts believe that the outcome of this review will impact HLB's future funding and drug development strategies. A successful approval would provide HLB with commercialization experience in the U.S. and a foundation for developing subsequent indications. Conversely, a failure could increase the burden of restoring investor confidence and securing funding for the company, which would need to pursue a reapplication for the liver cancer drug.

Meanwhile, it is noteworthy that BlackRock, the world's largest asset management firm, has been increasing its stake in HLB as it continues to acquire shares in domestic biotech companies. BlackRock raised its stake in HLB to 5.01% in March, increased it to 6.05% in June, making it the second-largest shareholder after Chairman Jin Yang-gon, and further raised it to 7.15% in July.

Particularly, the continued buying activity after HLB received CRLs for its liver cancer drug candidates Riboceranib and Camrelizumab has drawn attention. Market analysts interpret this as a positive assessment by BlackRock of HLB's chances for drug approval and its long-term corporate value.