HLB Completes Preparation for Pharmaceutical Sales in 36 US States

First License Obtained in New Jersey in May
Expanded to 36 States in 6 Months

HLB announced on the 8th that its subsidiary Elevar has completed preparations for pharmaceutical sales in 36 states in the United States.

HLB logo. [Image provided by HLB]

This comes about six months after Elevar first obtained a sales license from the New Jersey Department of Health in the US last May. In the US, to ship and sell pharmaceuticals, it is mandatory to acquire pharmaceutical sales licenses in all 50 states and the capital. Among these, 8 states allow license issuance after market approval.

Considering that commercialization preparation in the US takes more than a year, HLB has been simultaneously proceeding with various licenses, registrations, and marketing preparations along with the New Drug Application (NDA) process earlier this year.

The company explained that following the successful completion of the US Food and Drug Administration (FDA) mid-review and the inspection of the Lenvatinib manufacturing plant, preparations for commercialization are progressing smoothly.

According to analysis data from IQVIA, a global pharmaceutical market research firm, as of October, the market share of Avastin-Tecentriq, which held over 65% of the first-line treatment market for liver cancer, has dropped to about 52%, while the market share of Imfinzi-Imjudo has increased to 25%.

This is explained as due to the treatment limitations of the Avastin combination therapy. This therapy shows reduced efficacy and safety in patients with gastrointestinal bleeding or worsened liver function (ALBI grade 2). Real-world data presented at the International Liver Cancer Association conference reported that 77% of patients discontinued treatment within 12 months.

On the other hand, HLB’s Lenvatinib-Camrelizumab combination therapy demonstrated efficacy in all patient groups in global Phase 3 results and was analyzed to reduce the risk of death or severe progression by about 40-50% with low hazard ratios (OS 0.62, PFS 0.52). The discontinuation rate was also low at about 3.7% compared to other treatments.

An HLB official stated, "Unlike Avastin combination therapy or Imfinzi combination therapy, the Lenvatinib-Camrelizumab combination therapy can be used in all patient groups and has high safety, so we are confident it will capture more than 50% of the market within three years after launch."

This content was produced with the assistance of AI translation services.